IFPAC Preliminary Program 2014
Jan. 21 - Jan. 24, 2014



Sunday PM

Pre-Conference Workshop: Post Approval Change Management for PAT and RTRT-Scientific & Regulatory Considerations (1:00PM to 5:00PM) Grand A/B (included in the standard conference fee) OPEN TO ALL  
Chair(s): Christine Moore, FDA, Sharmista Chatterjee, FDA and Theodora Kourti, GSK


Introduction to Workshop/Welcome
Theodora Kourti, GSK and Christine Moore, FDA

Regulatory Perspective, FDA
Christine Moore, FDA, Silver Springs, MD

Regulatory Perspective, EMA
Sean Jones, EMA (remotely)

A Perspective from Non-Pharma: Chemometrics Models over the Decades: Strategies for Long-Term Support
Mary Beth Seaholtz and Wendy Flory, The Dow Chemical Company

Industrial Perspective - I
Gert Thurau, Hoffmann-LaRoche, Basel, Switzerland

Industrial Perspective - II
Theodora Kourti, GSK

Industrial Perspective - III
Lorenz Liesum, Novartis Pharma, Basel, Switzerland

Panel Discussion
Theodora Kourti, GSK, Christine Moore, FDA, Mary Beth Seaholtz, DOW, Lorenz Liesum, Novartis, and Gert Thurau, Hoffmann-LaRoche, Basel, Switzerland


Sunday PM

Pre-Meeting LC Workshop: The Role and Effective Application of Chromatography in Monitoring Processes and Process Development. (1:30PM to 4:30PM) (included in the standard conference fee) OPEN TO ALL  
Chair(s): Ernie Hillier, Senior Product Marketing Manager, Waters Corporation


Welcome/Introduction
Ernie Hillier, Senior Product Marketing Manager, Waters Corporation

Characterisation of Biopharmaceuticals using Liquid Phase Separation Techniques
Presenter: Dr. Jonathan Bones, Principal Investigator, NIBRT

Challenges and Solutions to implementation of Chromatographic analysis in PAT
Presenter: Hillary Hewitson, Process Analytics Business Development Manager, Waters Corporation

Establishing platform Analytical techniques for small molecule process development Additional examples in Chemical materials and Food Analysis
Presenter: Dr. Thomas Wheat, Principal Scientist, Waters Corporation

Analytical Toolkit for Biotherapeutic Development: Expanding Liquid Chromatography Applications
Presenter: Dr. Douglas Richardson, Biologics Analytical Program Lead, Merck

PAT Round Table Discussion



Monday AM

Plenary Session: IFPAC/QbD/PAT/ONSITE  
Chair(s): Scott Armstrong, John Kauffman, G.K. Raju and Martin Warman


Welcome/Introduction
Scott Armstrong, ExxonMobil, Baton Rouge, LA, John Kauffman, FDA, CDER, OPS, OTR, DPA, St. Louis, MO, G.K. Raju, Light Pharma, Boston, MA and Martin Warman, Vertex Pharmaceuticals, Boston, MA

FDA Pharmaceutical Quality Oversight: One Quality Voice
Lawrence Yu, Director of OPS, FDA, Silver Spring, MD

Risk and Knowledge Management (TBA)
Kevin Nepveux, VP, Pfizer

Towards Manufacturing Biologics on Demand
Chris Love, Professor, MIT, Lead on MIT DARPA Program

Continuous Drug Product Manufacturing (TBA)
Patricia Hurter, VP, Vertex Pharmaceuticals, Boston, MA

Risk Assessment and Life Cycle Management: Implementation Across Multiple International Facilities
Don Bartusiak, Chief Engineer, Process Controls, ExxonMobil Research and Engineering

Food Quality, Safety & Analysis
Colm O'Donnell, University College Dublin, Belfield, Dublin, Ireland, P. J. Cullen, Dublin Institute of Technology, Dublin, Ireland and Michael McCarthy, University of California Davis, Davis, CA


Monday PM I

International Harmonization for Implementation of Risk Based Review and Inspection  
Chair(s): Sharmista Chatterjee, FDA and Dolores Hernan, EMA, UK


Industry Perspective on Current Status of International Harmonization
Ganapathy Mohan, Merck

Update on FDA-EMA QbD Pilot (tag team presentation by FDA and EMA)
Dolores Hernan, EMA and Sharmista Chatterjee, FDA

Implementation of a Risk Based Review - PDMA Perspective
Takaaki Suzuki, PMDA

International Collaboration for a Risk Based Inspection: Industry Perspective
Vasiliki (Vee) Revithi, Roche

International Collaboration for a Risk Based Inspection: FDA Perspective
Alicia Mozzachio, FDA and Carmello Rosa, FDA (TBC), Silver Spring, MD

Panel Discussion - International Harmonization for Implementation of Risk Based Review and Inspection
All


Monday PM II

Risk Management Over Product Life Cycle - I (Brand)  
Chair(s): G. K. Raju and Rick Friedman, FDA


QRM for New Product Quality Assessment
Ramesh Sood, CDER, ONDQA, FDA, Silver Spring, MD

QRM: Process Performance and Product Quality Monitoring
Kira Ford, Director - Global Quality System, Eli Lilly Company

The Implementation of Risk Assessments for Analytical Methods and their Utility for Guiding Experimentation
Janice Ensing, James Morgado, Kimber Barnett, David Fortin, Jeffrey Harwood, Jian Wang, Pfizer

Integrating QRM into Existing Combination Products
Carlos Monteagudo, Director, Quality Assurance, Amgen

Risk Based Review and the Management of Residual Uncertainty in the Regulation of Biological Products
Jeff Baker, CDER, OBP, FDA, Silver Spring, MD

Quality Risk Management in our Supplier Quality System
Edward Cook and Marty Murawski, Hospira

Risk Assessment in Process Design, Development and Performance Management
Sander van den Ban, Oral Solid Dose Product Lead, GSK

Panel Discussion
All Speakers


Monday PM III

Process Monitoring & Control - I: Part 1: IbM - The Vision, Business Case, and Outlook  
Chair(s): Jun Huang and Mojgan Moshgbar


Intelligence based Manufacturing - Business Case & Short to Mid-term Outlook
Mojgan Moshgbar (Ph.D.), Director Advanced Manufacturing Technology Group, PGS, Pfizer

Precision Manipulation of Nanoscale Objects: in devices, in processes, and in patients
Benjamin Shapiro, Fischell Department of Bioengineering, Institute for Systems Research, University of Maryland, College Park, President and Cofounder, Otomagnetics, LLC, College Park, MD

Internet of Things and Cyber-Physical Systems: Paths to Smart Industry and Smart Cities
Sokwoo Rhee (Ph.D.), Presidential Innovation Fellow 2013-2014 and Associated Director, Cyber-Physical Systems, NIST

Next Generation Non-invasive Smart Sensor Technologies
Govind Rao (Ph.D.), Director, Center for Advanced Sensor Technology, University of Maryland Baltimore

Optimal Campaign Continuous Manufacturing Pharmaceuticals
Paul I. Barton and Ali M. Sahlodin, Process Systems Engineering Laboratory, Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA


Monday PM IIIb

Process Monitoring & Control - I: Part 2: IbM - Making it Real!  
Chair(s): Gretchen Allison and Vibhakar Shah


Advance Manufacturing Technology (AMT) in GMP Environment 1
Gretchen Allison, Pfizer, Global Quality and Ke Hong, Pfizer, Advanced Manufacturing Technology

Innovative Multipurpose NIR Spectroscopy for Real-time Physical and Chemical Characteristics of Dense Media & Counterfeit Detection
Yi-Chieh Chen, Sarra Tiernan and Suresh N. Thennadil, Department of Chemical and Process Engineering, University of Strathclyde, Glasgow, UK

Raising the Bar through Product Robustness with Enhanced Process Knowledge and Understanding
Jennifer Walsh, Manufacturing Technology, Bristol-Myers Squibb

Model Based Design and Operation of a Continuous Drug Product Manufacturing Process
Dr. Salvador Garcia Munoz, Modeling and Simulation Eli Lilly and Company

Implementing Advanced Manufacturing Technologies in GMP Environment: Regulatory Expectations and Considerations
Vibhakar Shah, (Ph.D.), Senior Policy Advisor, DGMPA/OMPQ/OC/CDER/USFDA

Panel Discussion: IbM - Making it Real!



Monday PM IV

Implementation of QbD for Analytical Methods  
Chair(s): John Kauffman, FDA and Sonja Sekulic


Opening Remarks: Implementation of QbD for Analytical Methods
Sonja Sekulic, Pfizer

Screening and Optimization Designs to Improve Method Performance and Robustness
John F. Kauffman and Daniel J. Mans, FDA, CDER, Division of Pharmaceutical Analysis St. Louis, MO

Analytical QbD: Risk Assessment and Design of Experiments Use in Method Development at Novartis Pharma and Sandoz, A Novartis Company (Double Time Slot w/ I-253)
Chris Balducci, Network Leader, Novartis Pharmaceutical Corp. and Dirk H. Erdmann, Head Analytics, Sandoz (joint presentation with Sandoz)

AQbD: Risk Assessment and Design of Experiments Use in Method Development at Novartis Pharma and Sandoz, A Novartis Company (Double Time Slot w/ I-242)
Dirk H. Erdmann and Pito Roslansky, Sandoz (joint presentation with Novartis)

Applying a Perfect Storm of Technologies to Drive QbD-aligned LC Method Development
Richard Verseput, S-Matrix, Eureka, CA

Opportunities and Challenges to the Application of Quality by Design Concepts to Analytical Methodology
Kimber Barnett, Pfizer

Advanced Concepts for Change Control of Analytical Procedures with ICH Q12 Coming
Joerg Hoffman, Merck

Panel Discussion - Implementation of QbD for Analytical Methods
All Speakers


Monday PM V

BioTech - I: Small Molecule Manufacturing & the Application of PAT & QbD (Industry Manufacturing Strategies)  
Chair(s): Antonio Moreira and John Higgins


A Qualitative Approach to Bioprocess Monitoring and Decision Making with NIR-Spectroscopy and MVDA
Dan Kopec, Field Marketing Manager - Sartorius Stedim North America, Bohemia, NY

Quality by Design Principles in the Development of Chemical Processes to Manufacture Small Molecule Drug Substances
Marco Gil, Claudio Rebelo and Rui Loureiro, Hovione Farmaciencia SA, Loures, Portugal

Application of PAT in Small Molecule Process Development (TBA)
Jeroen Bezemer, Amgen, Corp.

Rapid Microbiological Monitoring (RMM) Technologies for Purified Water Monitoring
Shinsuke Yamasaki, Engineer, Azbil Corporation, Japan and Scott Morris, Applications Engineering Manager, BioVigilant

The Human Side of QbD
Pierre Boulas, Biogen Idec, Cambridge, MA

Life Cycle Data Consolidation for Knowledge Management -Data Fusion across Pharma Manufacturing & R&D
Mojgan Moshgbar, Director of Advanced Manufacturing Technology, PGS, Pfizer

Cutting Edge Strategies for Effective Project Management of Clinical & Pharmaceutical Projects
Zizi Imatorbhebhe, Alliance BioPharm& Health Partners, Suwanee, GA

New Smart Cost Effective Platform for Automation of Pharmaceutical Production Sequencing and Optimization of the Changeovers and Inventory Carrying Costs
Jun Huang, Senior Manager, AMT, PGS, Pfizer, Rob Richard, Project Manager Stottler Henke LLC and Mojgan Moshgbar, AMT, PGS, Pfizer

Implementation of Enterprise Manufacturing Intelligence - Progress on the Road to Total Data Domination
Bryant LaFreniere, Mary Beth Seasholtz and Lloyd F. Colegrove, The Dow Chemical Company, Midland, MI


Monday PM VI

QbD - Applications and Tools - I  
Chair(s): Scott Furness, FDA, Theodora Kourti, Manoharan Ramasamy and Lorenz Liesum


Quality by Design (QbD) and Design Space Estimation - How to Create a Multidimensional and useful Description
Conny Vikstrom, Senior Application Specialist, Umetrics, Umea, Sweden

Evaluating the Design Space for the Batch Manufacture of an OTC Medicine
Tim Freeman, John Yin, Freeman Technology Inc. and Jun Huang, Pfizer Inc.

Investigation of Twin Screw Granulation: Integrating Experimental and Computational Approaches
A. Kumar (1,2), K.V. Gernaey (3), I. Nopens (1,*), T. De Beer (2) 1. BIOMATH, Dept. of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent University, Belgium 2. Laboratory of Pharmaceutical Process Analytical Technology, Dept. of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Belgium 3. CAPEC-PROCESS, Department of Chemical and Biochemical Engineering, Technical University of Denmark, Denmark

Leveraging Bayesian Statistics to Build a Better Design Space
Tara Scherder, Bruno Boulanger, Pierre Lebrun and Eric Rozet, Arlenda, SA, Flemington, NJ

Stability Testing and Intelligent Matrixing with a New DOE Method
Conny Vikstroem, Umetrics AB, Umea, Sweden

Process Analytical Tools for Microencapsulation Process for Biodegradable Polymer based Microspheres
Reddy Malleswara, Rao Dama Venugopala, Gangwal Jitendra Kumar, Majumdar Arijit, Chormale Sharad, Singhai Aditi, Sen Deepak, Jagdish Badgujar, Yeedibilli Vijay Kumar, Pravinchandra Kinalkumar, Venkata Sureshkumar, Bhagwatwar Harshal and Dhiraj Kumar Chopra, Dr Redddy's Laboratories Limited, Integrated Product Development, Telangana, India

Rapid DoE(c)- A New Approach to Efficient Experimentation
David Lauri Pla and Mojgan Moshgbar, Director, AMT, PGS, Pfizer

Case Study on QbD Development for a Solid Dosage Form, a Project Manager Perspective
Sudha Vippagunta; Jiahao Zhu; Chris Balducci; Dirk Spickermann; Sanni Matero; Lorenz Liesum and Colleen Ruegger, Novartis Pharmaceutical Corporation, East Hanover, NJ


Monday PM VII

Process Raman  
Chair(s): Brian Marquardt


Raman Spectroscopy: Beyond the Research & Analytical Laboratory
David Strachan [1], Maryann Cuellar [1], Pat Wiegand [1], Sean Gilliam [1], Harry Owen [1], Carsten Uerpmann [2], Herve Lucas[2], Bruno Lenain[2], [1] Kaiser Optical Systems, Inc., [2] Kaiser Optical Systems, SARL

How to make Coffee with a Raman Spectroscopy. Maybe not Coffee but pretty much everything else
Eunah Lee, HORIBA Scientific, Santa Clara, CA, Adrian Knowles, HORIBA Jobin Yvon SAS, Villeneuve d'Ascq, France, Andrew Whitley and Li Yan, HORIBA Scientific, Edison, NJ

Development of a Process Analytical Solution for Real-Time Monitoring of Continuous Flow Reactors
Thomas Dearing, MarqMetrix, Olav Bleie, University of Bergen, Michael Roberto, Infometrix Inc., Brian Marquardt, University of Washington

Automated Peak and Peak-Ratio Selection for Regression and Classification Models of Raman and LIBS Data
Jeremy M. Shaver, Eigenvector Research, Brian Marquardt, MarqMetrix, Tom Dearing, MarqMetrix and Sergey Mozharov, MarqMetrix

In situ Raman Monitoring of Heterogeneous Reaction Systems - IsoclastTM Active Manufacturing & Emulsion Polymerization
Xiaoyun Chen, Dow Chemical, Midland, MI

Application of Raman to Pharma and Bio-Pharma Process Design
Jessica Whelan, APC, Dublin, Ireland, Miriam Carr, APC, Dublin, Ireland, Mark Barrett, APC, Dublin, Ireland and Brian Glennon, APC, Dublin, Ireland & School of Chemical and Bioprocess Engineering, UCD, Dublin, Ireland

Utilisation of Raman Spectroscopy for Primary and Secondary Pharmaceutical Development
Allyson McIntyre*(1), Richard Hart(1), Nicholas Pedge(1), Anders Sparen(2), Olof Svensson (2), and Magnus Fransson (2), (1) AstraZeneca Macclesfield, Macclesfield, UK, (2) AstraZeneca R&D Moelndal, Moelndal

Aseptic Polysorbate Identification with Handheld Raman
Eric G. Roy, Ph.D. Product Manager, and Claire Dentinger, Ph.D. Sr. Applications Scientist, Rigaku Raman Technologies, Wilmington, MA

High Throughput Measurements of Content Uniformity of Pharmaceutical Tablets - Regulatory Strategy and QbD
Mark Mabry1*, Julia Griffen1, Andrew Owen1, Pavel Matousek2; 1CobaltLight Systems Inc., 2Science and Technology Facilities Council (STFC), *Presenter

Fluorescence Suppressed Time Resolved Raman Spectra of Drugs
Tatu Rojalin, Division of Pharmaceutical Biosciences, CDR, University of Helsinki, Finland, Mari Tenhunen, Photonic Devices and Measurement Solutions, VTT, Oulu, Finland, Clare J. Strachan, Division of Pharmaceutical Chemistry and Technology, University of Helsinki, Finland, Marjo Yliperttula, Division of Pharmaceutical Biosciences, CDR, University of Helsinki, Finland


Monday PM VIII

Chemometrics (COPA) - I  
Chair(s): Juergen von Frese, Christian Airiau and Brian Rohrback


Chemometrics Models Developed for Decades? : Strategies for Long-Term Support
Wendy C. Flory and Mary Beth Seasholtz, The Dow Chemical Company, Analytical Technology Center, Midland, MI

Sweeteners Determination in Table Top Formulations using Raman and Near-Infrared Spectrometric Methods and Chemometric Analysis
Sanjeewa R. Karunathilaka, Samantha Farris, Magdi Mossoba and Betsy Jean Yakes, FDA/CFSAN, College Park, MD

Understanding Conditions and Limitations of Inferential Spectrometry
Marc Trygstad, Yokogawa Corp. of America, Sugar Land, TX

Putting it All Together - COPA plus one Decade
M. A. Power and W. M. Doyle, Symbion Systems, Inc.

A Chemometrics Success Story Five Miles Underground
Christopher Jones, Halliburton, Houston, TX

Application of Multivariate SPC to CPV and Supply Chain Analytics
Louis Halvorsen, Chief Technical Offices, Northwest Analytics

Advanced Analytics, a Component of the Informatics Framework
Christian Y. Airiau, Research and Development, Advanced Manufacturing Technologies, GlaxoSmithKline King of Prussia, PA


Monday PM IX

Microscopy/Spectroscopy/Sensors  
Chair(s): Walter Henslee and Jason Dickens, GSK (TBC)


On the Use of X-ray Microscopy in the Analysis of Pharmaceutical Formulations
Joseph D. Ferrara, Rigaku Americas Corporation and Rigaku Corporation, Kensaku Hamada, Rigaku Corporation, Yosuke ito, Rigaku Corporation, Kazuhiko Omote, Rigaku Corporation and Yoshihiro Takeda, Rigaku Corporation, The Woodlands, TX

Automatic Classification of Powder Agglomeration inside Capsules through X-ray Image Analysis
Ryan Gosselin(1*), Emmanuel Vachon Lachance(1,2), Antoine Cournoyer(2), Fiona Clarke(3), 1. Department of Chemical and Biotechnological Engineering, Pfizer Industrial Research Chair, Universite de Sherbrooke, Sherbrooke, Canada, 2. Process Analytical Sciences Group, Pfizer Canada, Montreal, Canada, 3. Process Analytical Sciences Group, Pfizer United Kingdom, Sandwich, United Kingdom

In-line Monitoring of Pharmaceutical Pan Coating Process by Means of Optical Coherence Tomography
Daniel Markl, Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Guenther Hannesschlaeger, Research Center for Non-Destructive Testing GmbH, Linz, Austria; Stephan Sacher, Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Michael Leitner, Research Center for Non-Destructive Testing GmbH, Linz, Austria; Russel Pescod, ProCepT nv, Zelzate, Belgium; Andreas Buchsbaum, Research Center for Non-Destructive Testing GmbH, Linz, Austria; Johannes G. Khinast, Institute for Process and Particle Engineering, Graz University of Technology, Graz, Austria

Evolving Analytical Technologies for the Pharmaceutical Synthetic Chemist
Michael D. Jones(1), Sean M. McCarthy(1), James McKearin(2), Jon Kremsky(2), Andy Aubin(1), and Paula Hong(1) 1. Waters Corporation, Milford, MA; 2. Prime Organics, Woburn, MA

Compact Hydrogen Peroxide Sensor for Sterilization Cycle Monitoring
Krishnan R. Parameswaran, Clinton J. Smith, Kristin L. Galbally-Kinney, and William J. Kessler, Physical Sciences Inc., Andover, MA

Drag Force Flow Sensor as a Tool for Real-Time Assessment of Granule Densification in High Shear Wet Granulation: Effect of Process Parameters and Application to Scale-up in Placebo and Brivanib Alaninate Formulations
Ajit S. Narang1, Valery A. Sheverev2, Vadim Stepaniuk2, Sherif Badawy1, Tim Stevens3, Kevin Macias3, Avi Wolf1, Preetanshu Pandey1, Dilbir Bindra1, and Sailesh Varia1, 1 Drug Product Science and Technology, New Brunswick, NJ, 2 Lenterra, Inc., Newark, NJ, 3 Analytical and Bioanalytical Development, New Brunswick, NJ

Open Discussion



Monday Evening

Evening Discussion Session 1 (8:00PM-9:30PM)  
Chair(s): Theodora Kourti, GSK


NIRS Guideline by EMA - What are the Implications for Industry? (8:00PM-9:30PM)
Panel: Theodora Kourti, GSK, Lorenz Liesum, Novartis and Sonja Sekulic, Pfizer


Monday Evening

Special Evening Session - Training the Next Generation: Process Analyzer Technicians (8:00PM-9:30PM)  
Chair(s): Scott Armstrong, ExxonMobil and J.D. Tate, Dow Chemical


More details to follow shortly... check back for continuous updates....


Tuesday AM I

QbD - Applications and Tools - II  
Chair(s): Scott Furness, FDA, Theodora Kourti, Manoharan Ramasamy and Lorenz Liesum


QbD: Agency Perspective
Scott Furness, FDA, CDER, Silver Spring, MD

Application of QbD for Drug Products Containing Nanomaterials
Katherine Tyner, OPS, CDER, FDA

QbD/Control Strategies
John Groskoph, Pfizer

Value Realization through QbD/PAT Implementations at Merck
Manoharan Ramasamy, West Point, PA, John Higgins, West Point, PA, Busolo Wabuyele, Kenilworth, NJ and Cindy Starbuck, West Point, PA

Industry Example - Enhanced Control Strategy for Biologics
Gert Thurau, Hoffmann-LaRoche, Basel, Switzerland and T.G. Venkateshwaran, Roche/Genentech

PAT as an Advantage Developing Chemical Synthesis Processes for Drug Substances Manufacturing
Claudio Rebelo, Nuno Matos, Marco Gil, Ricardo Mendonca and Rui Loureiro, Hovione Portugal

Recent Activities conducted by PAT committee of JSPME for Implementation of PAT and QbD in a Japanese Pharmaceutical Society
Takayuki Murakami, Sumitomo Dainippon Pharma Co., Ltd. and PAT committee of Japan Society of Pharmaceutical Machinery and Engineering (JSPME), Osaka, Japan

Manufacturing Process Control with PAT: Substitution of off-line HPLC & GC by in-line IR spectroscopy
Christian Lautz, F. Hoffmann-La Roche Ltd., Basel, Switzerland


Tuesday AM II

Risk Management Over Product Life Cycle - II (Generics)  
Chair(s): G. K. Raju and Daniel Peng, FDA


Risk Based Review for Generic Applications
Andre Raw, CDER, Office of Pharmaceutical Science, FDA, Silver Spring, MD

QRM in Generic Drug Product Development
Padam Bansal, Amneal Pharmaceuticals

QRM for Knowledge Transfer: Regulatory Perspective
Juandria Williams, CDER, Office of Compliance, FDA, Silver Spring, MD

QRM in Generic Industry
Siva Vaithiyalingam, Teva Pharmaceuticals

QRM for Quality & Compliance: Regulatory Perspective
Rick Friedman, CDER, Office of Compliance, FDA, Silver Spring, MD

Case Study on Quality Risk Management during Product Life Cycle
Chetan Doshi, Director, Formulation Development Solid Dose, Apotex, Inc.

Using Risk Assessment Tools to Lead Development into the Right Direction: A Case Study
Petra Brozic, Senior Scientist, Pharmaceutical Development, Sandoz

Panel Discussion
All Speakers


Tuesday AM III

Process Monitoring & Control-II: PAT Implementation for Drug Product Development and Manufacturing  
Chair(s): Tim Stevens and Ajit S. Narang


Application of Multivariate Analysis (MVA) for Efficient Drug Product Development: Industrial Perspectives
Zhenqi (Pete) Shi and Sal Garcia, Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN

Ensuring Data Availability to Support a Fully Integrated Control Strategy
Kelly Swinney and Martin Warman, Vertex Pharmaceuticals, Inc., Boston, MA

Implementation of Supersaturation Control in Large Scale Crystallization
Jeff Nye and Brenda Remy, Bristol-Myers Squibb

Implementation of On-line Near-IR Measurements for Process Control during Crystallization of an API Intermediate
Robert M. Leasure, David T. Jones, Jeffrey C. Juhnke, James F. June and Russell J. Rowgo Pfizer Global Supply, Kalamazoo MI

Development of a Process Monitoring System for a Transdermal Drug Delivery System using Near Infrared Chemical Imaging
Robert W. Bondi, GSK, King of Prussia, PA, Carl A. Anderson and James K. Drennen, Duquesne University, Pittsburgh, PA

Network based PAT System for Blending Process Control - Implementation Challenges
Paul Brodbeck, Control Associates, Engineering Manager, Umesh Pai, Sun Pharmaceutical Industries, Director R&D, Sridhar Valluri, Sun Pharmaceutical Industries, Process Engineer R&D and Todd Outwin, Sun Pharmaceutical Industries, PAT Associate Control Associates Inc.

Flexible PAT System for Pharmaceutical Manufacturing - Blend Uniformity Analysis Case Study
Umesh Pai, Sun Pharmaceutical Industries, Director R&D, Sridhar Valluri, Sun Pharmaceutical Industries, Process Engineer R&D, Todd Outwin, Sun Pharmaceutical Industries, PAT Associate, Cranbury, NJ

Enterprise PAT Solutions for Commercial Manufacturing: A Case Study on Real-Time NIR Blend Monitoring and NIR Tablet Assay
Elvin Varghese, Bristol-Myers Squibb and Andy Sweeney, Optimal Industrial Automation, Ltd.

A Case Study in Intelligence based Manufacturing - End-to-End Optimization of Solid Oral Dosage Unit Operations
Jun Huang, Ph.D. and David Lauri Pla, Ph.D., Advanced Manufacturing Technology, Pfizer Global Supply, Peapack, NJ


Tuesday AM IV

Lifecycle Management of Analyzer and Method Robustness  
Chair(s): Gert Thurau and John Kauffman, FDA


Lifecycle of NIR Analytical Methods - Regulatory Perspective (TBC)
Bogdan Kurtyka, FDA, Silver Spring, MD

A Critical Discussion of EMA's 2014 NIR Guideline and Addendum: The foreseen impact on NIRS use by the Pharmaceutical Industry
Maria B. Campos1, Pedro M. Felizardo1, Jose C. Menezes 2, (1) 4Tune Engineering Ltd - Technology Services & Products, Lisbon, Portuga, (2) IBB-Institute for Biotechnology & Bioengineering, Lisbon, Portugal

Inline Near-infrared Spectroscopic Moisture Determination during Fluid Bed Drying of Pharmaceutical Granules: Method and Technical Challenges
Lene Maurer, Pascal Chalus and Martin Wunderlich, F. Hoffmann-La Roche, Ltd., Basel, Switzerland

The "Science of Quality" and Patient Benefit
Helen Strickland, Senior Statistical Consultant, Product Lifecycle Management CC, GSK

Analytical Procedures and Method Validation
Lucinda Buhse, FDA, St. Louis, MO

Implementation and Maintenance of Process Models and Methods in Spray Drying
Joseph Medendrop, Vertex, Boston, MA

Experiences Implementing Real Time MVDA Clean-In-Place Systems
Saucedo, V., Li, Z., Schimizzi, D., Su, M., Phillips, A., Hudson, T. and Gan, B., Genentech, South San Francisco, CA

Maintenance of Multivariate Process Models
Petter Moeree, Director, GPM, Umetrics, Malmoe, Sweden


Tuesday AM V

BioTech - II: MSAT in Biologics Manufacturing  
Chair(s): Jose C. Menezes and Ranjit R. Deshmukh


Designing and Knowing the Space for CIGB 550-E7, an HPV Candidate Vaccine
Miladys Limonta Fernandez, Laura Varas, Maelys Miyares, Dayana Soler and Isis Torrens, Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba

Single Use Capacitance Measurements of Viable Cell Volume
Stuart Tindal1, Markus Weise2, Jochen Scholz1, Sven Gross1, Henry Weichert1, , Thomas Schnitzler2, Manfred Biselli2, Mario Becker1 1.Sartorius Stedim Biotech GmbH, Goettingen, Germany. 2. FH Aachen, Campus Juelich, Juelich

Using Monolithic Chromatographic Columns to Improve the Efficiency and Robustness of Biopharmaceutical Manufacturing
Nika Lendero Krajnc, Lidija Urbas and Ale trancar, BIA Separations, Slovenia

Automated Single use Mini-bioreactors: can they deliver scalable results and improve protein expression performance?
Barney Zoro (1)*, Kevin McHugh (1), Amy Walde (2), Alexis Bossie (2)(1)TAP Biosystems - Sartorius, Royston, Herts, UK, (2)Lonza, Walkersville, MD, USA

Online UPLC Applications for Biotherapeutic Development
Douglas D. Richardson 1, Zhi Chen 1, Maria Khouzam 2, Xiaodun Mou1, Daisy Richardson1, John Higgins2, and David Pollard 1, 1- BioProcess Development, Merck Research Labs, Kenilworth NJ, 2- Process Analytical Technology, Merck Manufacturing Division

Understanding PAT Quality Data Management in Development and Manufacturing Environments
Justin Moretto, Biogen Idec, Raleigh, NC, Co - authors, John Paul Smelko - Biogen Idec, Raleigh, NC and Pamela Bruen Docherty, Siemens, Spring House, PA

Material Homogeneity during a Filling Operation: Retrospective Analysis of Historical Data, Process Validation and Routine Monitoring
Kedar H. Dave, Bristol-Myers Squibb, East Syracuse, NY

Panel Discussion (All)



Tuesday AM VI

Imaging  
Chair(s): Steve Hammond and Carl Anderson


The use of UV Imaging to Study the Intrinsic Dissolution of Active Pharmaceutical Ingredients
Jesper Ostergaard, Associate Professor, Ph.D., Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen O, Denmark

Mixing and Transport during Pharmaceutical Twin-screw Wet Granulation: Experimental Analysis via NIR Chemical Imaging
Ashish Kumar; Jurgen Vercruysse; Maunu Toiviainen; Pierre-Emmanuel Panouillot; Mikko Juuti; Valerie Vanhoorne; Krist V Gernaey; Ingmar Nopens; Thomas De Beer, Ghent University, Ghent, Belgium

PAT for Packaging: Real time monitoring of Pharmaceutical Bottles Induction Sealing Process
Fabian Schapiro, DIR Technologies, Haifa, Israel

Development of a Multi-Functional Particle Characterization System for Analysis of Pharmaceutical Powders
Rudy Hofmeister1, Scott Tandy1, Steve Hammond2 and Joep Timmermans2, 1H2Optx Inc., San Jose, CA, USA, 2Pfizer Inc., Peapack, NJ, USA

Real-time Quantitative Material Characterization - Process Fingerprinting & Smart Transfers
Ning Zhang, Post Doc Fellow, AMT, PGS, Pfizer, Mojgan Moshgbar, Director, AMT, PGS, Pfizer, David Lauri Pla, Manager, AMT, PGS, Pfizer and Jun Huang, Senior Manager, AMT, PGS, Pfizer

Imaging Advancement (TBA)
Mojgan Moshgbar and Ke Hong, Pfizer

Total Surveillance! Inline Monitoring of Tableting with NIR Chemical Imaging
P.R. Wahl*, O. Scheibelhofer*, S. Sacher*, P. Kerschhaggl**, J.G. Khinast*,**** Research Center Pharmaceutical Engineering (RCPE) GmbH, Graz, Austria, ** EVK DI Kerschhaggl GmbH, Raaba/Graz, Austria, *** Graz University of Technology, Institute of Process and Particle Engineering, Graz, Austria

Developing a new PAT Device and Algorithms for the In situ Imaging of Crystallization
Toufic El Arnaout, P.J. Cullen and Carl Sullivan, Dublin Institute of Technology, Dublin, Ireland

Image Analysis (TBD)
John Bobiak, BMS


Tuesday AM VII

NeSSI  
Chair(s): Mel Koch


Over the past fifteen years there has been an increasing industrial interest in the development and application of new technology tools for enhancing global industry related initiatives such as: Quality by Design (QbD), Process Analytical Technology (PAT), and Process Optimization. One of the key developments that has enhanced advances in these areas is in the standardization of process sampling, as exemplified by NeSSI(TM) (the New Sampling and Sensor Initiative). The Center for Process Analysis and Control (CPAC) has provided oversight for this program.
Continued developments of the NeSSI(TM) platform have expanded its use from sampling a variety of process streams to becoming a platform for process sensors and communication to the process control systems. The data from these measurement tools contributes to developing more effective process control strategies - a goal that many companies are trying to achieve.

Introduction to the NeSSI Session
Mel Koch, University of Washington (UW), CPAC/APL, Seattle, WA

NeSSI is 15 Years Old Now - and Ready for Prime Time
Steve Doe, Parker

Application of Raman Spectroscopy for Real-Time Monitoring of Continuous Flow Reactors
Brian J. Marquardt, Michael Roberto and Thomas I. Dearing, Applied Physics Laboratory, University of Washington, Seattle, WA

OptografTM and "Pipe-Centric" Process and Sampling Interfaces - The New Paradigm for a Total Process Analytical System Solution
Peter van Vuuren, Kaiser Optical Systems Inc. (KOSI), Joe Slater, KOSI, David Faulkner and Philippe Coric, Astute

Online Process Control using Modular Fluid Delivery and Fast & Micro Process Gas Chromatography: From the Sample Point to the DCS Connection
John Crandall, President, Falcon Analytical and Ned Roques, Chief Chromatography Officer, Falcon Analytical, Ronceverte, WV

In-Process Sampling Systems
Neil Breton, Solvay, Belgium

OPC-UA/ADI - A better way to provide System Device Integration
Anders Martinsson, ABB

Using a Benchtop NMR as a Reaction Monitoring System
Dr. Andrew Coy, CEO, Magritek, San Diego, CA

Managing Big Data from the Laboratory to Manufacturing
Martin Gadsby, Optimal Industrial Automation Limited, UK


Tuesday AM VIII

Advanced Separations - I: Technology & Applications - FastGC, HPLC & Data Systems  
Chair(s): John Crandall


Historical Overview Fast & Micro Gas Chromatography
Dr. Edward Overton,Professor Emeritus, Dept. of Environmental Sciences, Louisiana State University School of the Coast & Environment, Baton Rouge, LA and John Crandall, Falcon Analytical, Ronceverte, WV; Presenter: John Crandall

Considerations in Processing Heavier Oils by Fast GC
Brian Rohrback, Infometrix, Inc., Bothell, WA

Fast GC Performance in the Real World: Multi Lab Studies for Repeatability & Reproducibility
John Crandall, President Falcon Analytical, Ronceverte, WV

Fast GC Analysis of Headspace Monitoring for Bioreactors
Coauthors: Darren Hydutsky, Jud Orescan and Doug Stilwell, DuPont; Presenter: Darren Hydutsky

Advances in Micro Gas Chromatography for Fixed Gases and Light Hydrocarbon Analysis on a Micro GC Fusion
Debbie Alcorn, INFICON, Inc., East Syracuse, NY

Advanced Separations (TBA)
Curt Novak, Global Business Development, Agilent

Recent Advances in Chromatography Data Systems Software: A More Complete Solution including Labs, At-Line, Online and Transportable: Part 1
George Schreiner, Vice President Technology, ChromPerfect

Recent Advances in Chromatography Data Systems Software: A More Complete Solution including Labs, At-Line, Online and Transportable: Part 2
George Schreiner, Vice President Technology, ChromPerfect


Tuesday AM

IFPAC - Food Symposium I: Emerging Technologies with Focus on Traceability and Contamination  
Chair(s): Michael McCarthy, Ph.D., University of California Davis, Davis, CA and Carol Zrybko, Ph.D., Mondelez International, East Hanover, NJ


Session Overview
Food safety incidents have reduced consumer confidence in the food industry and supply chain prompting increased government intervention and regulation on food safety and food defense. Rapid analysis methods - particularly in the area of microbial and chemical threat agent detection - are being developed at an ever accelerating pace. This session will focus on emerging technologies in analytical/detection methods, rapid bio-monitoring and genetic fingerprinting in a response to recent contamination issues.

A Dual-sensor Method for the Assessment of Minced Beef Microbial Quality
A.I. Ropodi, D.E. Pavlidis, D. Loukas, P. Tsakanikas, E. Z. Panagou and G.-J.E. Nychas, Agricultural University of Athens, Department of Food Science & Human Nutrition, Laboratory of Microbiology and Biotechnology of Foods, Athens, Greece

The Role of Vibrational Spectroscopy in Brand Protection and Food Product Assurance
Gerard Downey and Ming Zhao, Teagasc Food Research Centre, Ashtown, Dublin, Ireland and Colm O'Donnell, University College Dublin, Belfield, Dublin, Ireland

Towards the Automation of Food Quality/Contamination Assessment via Non Invasive Techniques
Tsakanikas Panagiotis, Efstathios Z. Panagou and GeorgeJohn E. Nychas, Laboratory of Microbiology and Biotechnology of Foods, Department of Food Science and Human Nutrition, Agricultural University of Athens, Athens, Greece

Estimation of Total Phenolic Content/Antioxidant Levels in Food Samples using CE (IV) - Rhodamine 6G Chemiluminescence in a Novel Microfluidic Device
Butheina Al Haddabi, Dr.Haider Al Lawati and Prof. Fakhr Adin Suliman, Royal Court Affairs, Fanja, Muscat, Oman

In situ Particle and Droplet Measurement for Monitoring and Optimization of Suspensions and Emulsions in the Food Industry
Guillermo Smart and Terry Redman, Mettler Toledo Particle System Characterization, Columbia, MD

Supplementing Lab Analysis with Inline Measurements
Ola Wesstrom, Endress+Hauser Inc., Greenwood, IN

The Role of NMR for Food Quality Assurance
Michael McCarthy, Ph.D., University of California Davis, Davis, CA


Tuesday PM I

QbD - Applications and Tools - III  
Chair(s): Scott Furness, FDA, Theodora Kourti, Manoharan Ramasamy and Lorenz Liesum


Applications of Dynamic Light Scattering as PAT for on-line Particle Characterization
Alon Vaisman, Malvern Instruments, Westborough, MA

Fully Automated Process Analytical Solutions for Advancement in Process-NIR and Biotech Process Control
Paul Pulicken, Bayer Technology Services, Baytown, TX and Jens Traenkle, Bayer Technology Services GmbH, Germany

The Evolving Role of Automated Sample Preparation in Support QbD, PAT and Analytical Method QbD in the Pharmaceutical Industry
Robert Houser and Carol Moynihan, SOTAX, Dedham, MA

An Efficient, Maintenance Free and Approved Method for Spectroscopic Control and Monitoring of Blend Uniformity: The moving F-test
Rut Besselinga,f, Michiel Damena,f, Thanh Tranb, Thanh Nguyenc,f, Kaspar van den Driesd,f, Wim Oostrae,f and Ad Gericha,f, a. InProcess-LSP, Oss, The Netherlands.b. Center for Mathematical Sciences, Merck/MSD, Oss, The Netherlands.c. InnoCore Pharmaceuticals, LJ Zielstraweg 1, Groningen, The Netherlands.d. Patheon, Tilburg, The Netherlands.e. Abbott Healthcare Products, C.J. van Houtenlaan Weesp, The Netherlands.f. Pharmaceutical Sciences, Merck/MSD, Oss, The Netherlands

The Final Steps for QbD/PAT Implementations: Method Transfers and Parallel Testing- Case Studies from API and Secondary Manufacturing
Lorenz Liesum, Antonio Peinado and Dominique Kummli, Novartis Pharma, Basel, Switzerland

Using PAT and QbD Principles for Process Understanding in the Biopharmaceutical Industry
Antonio Peinado, Novartis

QbD of a Hot Melt Extrusion (HME) Process from Development to Commercialization
Brandye Smith Goettler, Cindy Starbuck and Manoharan Ramasamy, MERCK/MSD, West Point, PA

Sustainable PAT Systems in API Manufacturing Part 1: The Implementation of an In-process mid-IR PAT System for the Safe Operation and Control of a Highly Energetic Sodium Borohydride Reduction Reaction Part 2: Bridging the Gap between Process Quality and Quality Control with QC-PAT.
John O'Reilly, Roche


Tuesday PM II

Product Lifecycle and QA  
Chair(s): Tara Gooen Bizjak, FDA and Ravi Tejwani


Evolution of Control Strategy and Specifications over a Product Lifecycle
Ravi Tejwani, Bristol-Myers Squibb

Building a Dynamic, Lifecycle-Focused Quality System: A Regulatory Perspective
Christina Capacci-Daniel, FDA

Developing knowledge over product lifecycle through Continuous Manufacturing
Yanxi Cain, Novartis Pharma AG

The Symbioses of the Control Strategy and the CPV Programme
Line Lundsberg, NNE Pharmaplan

Linking "Regulatory Commitments" to Post Approval Changes
Robert Iser, FDA

Update on ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle
Ashley Boam, FDA

Panel Discussion



Tuesday PM III

Using Process Capability to Ensure Pharmaceutical Product Quality - Industry and Regulatory Perspective (Brand and Generics)  
Chair(s): Daniel Peng, FDA, Karthik Iyer, FDA and George Millili, Genentech - ISPE


Detecting and Responding to Unintended Variability
Arnian Zilian, Novartis

Assessment of Product Performance from Development through Launch
Thomas P. Garcia, Pfizer

Process Capability in 21st Century Pharmaceutical Manufacturing
Johna Norton, Lilly

The Quality Journey-From Good to Great
Martin Van Trieste, Amgen

Process Capability - The Balance of Compliance and Performance
Jason J. Orloff, PharmStat

Cpk<1.33, What now?
Paul Stojanovski, Teva

Using Process Capability to Ensure Pharmaceutical Product Quality
Daniel Peng, FDA, Silver Spring, MD

Panel Discussion - Industry and Regulatory Perspective
All speakers and Audiences


Tuesday PM IV

Enabling Technologies to Continuous Manufacturing: International Consortium for Innovation and Quality in Pharmaceutical Development - IQ  
Chair(s): Sonja Sekulic, John Bobiak and Doug Both


Session Overview
Continuous manufacturing is being embraced by the industry and there is growing interested in implementing processes through this paradigm. The drivers to advances in continuous manufacturing have been sensor technology, miniaturization, process analytics, risk management, statistics and modeling. This session will focus on the examples of these analytical tools both from a hardware and software point of view that enable a robust, well controlled continuous process is developed, transferred and implemented. Small molecule and biologics will be represented as well as drug product and API manufacturing.

Optimizing a Continuous Tableting Process by Understanding Granule Properties
Andrew Birkmire, GEA Process Engineering, Inc., Tim Freeman, Freeman Technology, Ltd. and Joshua Hullen, GEA Process Engineering, Inc.

Control Strategy Enabling Technologies for Continuous Processing
Kevin Macias, Tim Stevens and Aditya Vanarase Bristol-Myers Squibb Co., New Brunswick, NJ

Continuous Bio-manufacturing - New Developments in Sensors and Automation
Christian Grimm, Sartorius Stedim

Challenges and Opportunities of Implementing Process Control in Continuous Manufacturing of Drug Products
Zhenqi (Pete) Shi and Sal Garcia, SMDD, Eli Lilly and Company, Indianapolis, IN

Increasing Online Measurement Density and Reliability in Continuous Processes
Tomas Vermeire, GEA, Antwerpen, Belgium

PAT for Drug Product Continuous Process: from Understanding to Control
Yang (Angela) Liu, Pfizer Inc., Groton, CT

Enabling Direct Compression Continuous Tablet Manufacturing via Dry Coating through a Predictive Material Sparing Approach
Laila Jallo, Zhonghui Huang, Liang Chen, James Scicolone, and Rajesh N. Dave, New Jersey Center for Engineered Particulates New Jersey Institute of Technology Newark, NJ

Allotrope Foundation PAT Workshop Readout: Opportunities to realize immediate value to the industry via implementation of the standardized Allotrope Framework
Terry Tougas, Boehringer-Ingelheim/Allotrope Foundation, Dana Vanderwall, Bristol-Myers Squibb/Allotrope Foundation and Gang Xue, Amgen/Allotrope Foundation


Tuesday PM V

BioTech - III: Process Control for Biotechnology/Pharmaceutical  
Chair(s): Cenk Undey and Jose C. Menezes


Effect of MVDA Data Structures in Bioprocess Monitoring
Zheng Li, Hamilton, R. and Saucedo, V., Genentech, South San Francisco, CA

Initial Report on the Use of Natural-Abundance Stable-Isotopic Analysis in a Continuous, In-Process Fermentation Bioreactor and in Biologic Drugs (Heparin)
J. Jasper1, F. Zhang2, R. Linhardt2, R. Poe3, M. Gupta4, and B. Leen4, 1Nature's Fingerprint(R) / Molecular Isotope Technologies LLC, 2Rensselear Polytechnic Institute, 3Birch Biopharmaceutical LLC, and 4Los Gatos Research Inc.

Optical Coherence Tomography based Freeze Drying Microscopy
William Kessler, Mircea Mujat and Kristin Galbally-Kinney Physical Sciences Inc., Andover, MA and Vamsi Mudhivarthi and Michael Pikal, Department of Pharmaceutical Sciences, School of Pharmacy University of Connecticut Storrs, CT

Application of Online Feed Control Using Raman Spectroscopy in Cell Culture Bioreactor
Tony Wang and Cenk Undey, Amgen, West Greenwich, RI

Taking advantage of PAT and Process Control in Small Scale Bioproduction
Barbara Kavsek, Martin Joksch,Maximilian Besenhard, Siemens Corporate Technology, Vienna, Austria and Kjell Francois, Siemens Industry, Belgium

Combining Process and Spectroscopy Data in Development and Implementation of Multivariate Batch Models for Real-time Process Monitoring Applications
Anna Persson - MKS Umetrics, Wilmington, MA

Development of PAT Applications of Conventional and Single use Probes with Dielectric Spectroscopy in Bioprocessing
Dr. John Carvell and Dr. Aditya Bhat, Aber Instruments Ltd., Aberystwyth, Ceredigion, UK

Next Generation Bioprocesses using Online Monitoring and Control
Hamidreza Mehdizadeh, David Lauri and Mojgan Moshgbar, Advanced Manufacturing Technology, Global Technology Services, Pfizer


Tuesday PM VI

Particle Characterization  
Chair(s): Zhigang Sun, FDA and Nicolas Abatzoglou


PAT for Particle Size and Zeta Potential On-line Measurement using Ultrasound
Andrei Dukhin and Sean Parlia, Dispersion Technology Inc, Bedford Hills, NY

A PAT-based Experimental Methodology relating Velocity Profiles in Flowing Powder Mixtures with Cohesion/adhesion Parameters
Nicolas Abatzoglou(*), Oumaima Chaib and Ryan Gosselin, (*) Corresponding author, Universite de Sherbrooke, Department of Chemical & Biotechnological Engineering Pfizer Chair, Sherbrooke (Quebec), Canada

At-line DLS for Real-Time Monitoring of Particle Size in a Nanoemulsion Process
Ken Bernstein, Greg Troiano and Abhimanyu Sabnis, BIND Therapeutics, Inc., Cambridge, MA

In-situ Monitoring of High Shear and Fluid Bed Processing using Spatial Filter Velocimetry
Alon Vaisman, Malvern Instruments, Westborough, MA

Structural Characterization of IgG1 mAb Aggregates and Particles Generated under Various Stress Conditions
Srivalli Telikepalli, Ozan Kumru, Cavan Kalonia, Reza Esfandiary, Sangeeta Joshi, C.R Middaugh, and David B. Volkin, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS

Tracking the Fate of Agglomerated API in the Drug Product Process with NIR Chemical Imaging
Megerle Escotet, Gary McGeorge and Boyong Wan, Bristol-Myers Squibb New Brunswick, NJ

Characterization of Particles using Raman and FBRM Technology in Commercial API Manufacturing
Carlos Orihuela, Lei Cai and Hsien-Hsin Tung, AbbVie, Inc.

In-process Particle Size Analysis for Commercial Pharmaceutical Manufacturing
Zhigang Sun, Ph.D, Division of Process Assessment II, Office of Process and Facilities Office of Pharmaceutical Quality, CDER, FDA, Silver Spring, MD

Application of EYECON an Online Non Product Contact Process Analytical Technology to Perform Particle Characterisation during Fluidised Bed Processes
P. Cruise*, Ian Jones*, S. Banahan*, C Cortazzo^, Joachim Froehlich^, Lilia Sprich^ and Raoul Pila^, * Innopharma Labs, Ireland, ^ Glatt GMBH Process Technology, Binzen, Germany

Development and Evaluation of a Novel, Multi-functional Particle Characterization System for Analysis of Pharmaceutical Powders and Solids
Chi-Shi Chen (1), Pierre Philippe Lapointe-Garant (2), Helene Quach (4), Jean Sebastien Simard (2), Joep Timmmermans (1), Steve Hammond (1), Rudy Hofmeister (3), Scott Tandy (3), Prof. Nicolas Abatzoglou (4), (1) Pfizer Inc., Peapack, NJ, USA, (2) Pfizer Inc., Montreal, Canada, (3) H2Optx, San Jose, CA, USA, (4) Universite de Sherbrooke, Sherbrooke, Canada


Tuesday PM VII

Mass Spectroscopy/Process Spectroscopy  
Chair(s): Bob Bear


Process Mass Spectrometry as a Tool for Process Control, Monitoring and Development
Todd Colin Ph.D. (Presenting Author) and Robert Wright Ph.D., Thermo Fisher Scientific, Sugar Land, TX

A New Simple & Robust Process FT-NIR Spectrometer with Small Footprint and Extended Maintenance Interval
Thomas Buijs and Michael Simpson, ABB, Quebec, Canada

Enhanced Raman Analyzer for Real Time Monitoring of Recycled Polymer Extrusion - An Integrated Approach from Development through Deployment
Yusuf Bismilla and Mark Kemper, Tornado Spectral Systems, Toronto, Canada, Richard Kramer, Applied Chemometrics Inc., Dr. Mike Power, Symbion Systems Inc. and Edmir Silva, Unifi Manufacturing Inc.

A Highly Reliable Sensor for Nickel Carbonyl and Iron Carbonyl in Ambient Air
Henry Buijs, and Thomas Buijs, ABB, Quebec, Canada

Novel Hydrogen Sensor for Applications in the Petrochemical and Power Industries
Thomas Buijs, and Michael Simpson, ABB, Quebec, Canada

New Frontiers for Global Fingerprinting of Ultra-trace Elements and Emerging Contaminants
Candace E. Rowell, Nora E. Kuiper, Basem Shomar and Hugues Preudhomme, Qatar Environment, Energy Research Institute (QEERI - Qatar Foundation), Doha, Qatar

Panel Discussion



Tuesday PM VIII

Advanced Separations - II: Technology & Applications - FastGC, HPLC & Data Systems  
Chair(s): John Crandall


Data Processing in a Fast GC World
Brian Rohrback, Infometrix, Inc., Bothell, WA

Application in On-Line Sample Preparation Techniques for Process Analytical RSLC and HPIC Systems
Mike Doyle, Thermo Fisher Scientific, Sunnyvale, CA

Collaborative Development and Evaluation of a Liquid Chromatography Interface for Monitoring Process Development
Ernest J. Hillier, Charles H. Phoebe, Aaron D. Phoebe and Thomas E. Wheat Waters Corporation, Milford, MA

Considerations for Integrating a Liquid Chromatographic System within a Manufacturing Facility for the Analysis of Samples for Real Time Product Control
Charles H. Phoebe, Jr., Ernie J. Hillier and Aaron D. Phoebe, Waters Corporation, Milford MA

Mass Spectral Identification of Sample Components with Conventional Chromatographic Methods
Thomas E. Wheat, Daniel Root and Patricia R. McConville, Waters Corporation, Milford, MA

Market Significance, Fast GC (TBA)
John Crandall, Falcon Analytical, Ronceverte, WV

Chromatography: The Stepchild? Old Reliable? The Workhorse of Analytical Chemistry!
Moderator: John Crandall, President Falcon Analytical, Panelists: To be announced, the authors & attendees


Tuesday PM

IFPAC - Food Symposium II: Food Safety  
Chair(s): Luis E. Rodriguez-Saona, Ph.D., The Ohio State University, Columbus, OH and Bei Ma, M.S., United States Pharmacopeial Convention, Rockville, MD


Session Overview
Food pathogens create an enormous social and economic burden on communities and health systems continuing to be a source of concern for consumers, federal government, and industry. The US Government has identified a number of previously unrecognized food vehicles as causes of foodborne disease, and the development of control strategies for pathogens and contaminants need to address a wide range of foods. This session will focus on detection technologies for foodborne pathogens addressing sensitivity, specificity, speed of testing, and use under a variety of conditions to ensure safe foods.

Untargeted Screening of Extra Virgin Olive Oil Sold in the US for Assessment of Authenticity by using FT-NIR Spectroscopy and Chemometric Analysis
M.M. Mossoba1, S. Ranasinghe1, H. Azizian2, A. Fardin Kia1, P. Delmonte1, C.T. Srigley1, L. Vaclavic1, C. Ridge1, G. Mazzola1, J.K.G. Kramer3, and J. Callahan1 1FDA, CFSAN, ORS, College Park, MD, USA,2NIR Technologies, Oakville, ON, Canada, 3Guelph Food Research Center, Agriculture and Agri-Food Canada, Guelph, ON, Canada

Portable FT-IR Spectrometers for Authentication of Food Ingredients
Luis E. Rodriguez-Saona Food Science and Technology Dpt., The Ohio State University, Columbus, OH

Chemical Fingerprinting for Authentication and Process Control
James Harnly, Craig Byrdwell and Pei Chen, Food Composition and Methods Development Lab, Beltsville Human Nutrition Research Center, Agricultural Research Service, U.S. Department of Agriculture, Beltsville, MD, USA

Rapid Quantitative Analysis of Melamine in Milk by Surface-Enhanced Raman Spectroscopy Using Gold Nanoparticle Reagent
Bei Ma1 and Jing Zhang1, 2, 1 United States Pharmacopeial Convention, Rockville, MD, United States, 2 China Beijing Center for Disease Prevention and Control, Beijing, China

Potential Adulterant Screening and Quality Assessment of Dietary Supplements Using Multiple Rapid Detection Technologies
Bei Ma1 and Jing Zhang1, 2, 1 United States Pharmacopeial Convention, Rockville, MD, United States, 2 China Beijing Center for Disease Prevention and Control, Beijing, China

Evaluation of Food Grade and Pharmaceutical Grade Microcrystalline Cellulose Using Multiple Rapid Spectroscopic Technologies
Bei Ma1, Linbo Wang2, Beijia Shi3 and Yong Liu1, 1The United States Pharmacopeia Convention, Rockville, MD, USA, 2China Shanghai Institute for Food and Drug Control, Shanghai, China, 3China Jiangsu Institute for Food and Drug Control, Nanjing, China

Open Discussion



Tuesday PM

IFPAC Poster Session  
Chair(s): Antonio Moreira and Walter Henslee


Posters - Exhibit Hall/Exhibit Hall Foyer


Seprion-coated microcantilever Sensors for PrPsc Detection
Elena Bozzetta 1, Danilo Pitardi 1, Daniela Meloni 1, Maria Mazza 1, Riccardo Castagna 2, Ivan Ferrante 2, Carlo Ricciardi 2, Maria Caramelli 1, 1: Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d'Aosta, Turin, Italy 2: Politecnico di Torino, Dipartimento di Scienza dei Materiali e Ingegneria Chimica, Turin, Italy

Optimization of a Reporter Gene Assay to Disclose Illicit Treatments by Corticosteroids in Bovine Urine
Elena Bozzetta, Danilo Pitardi, Daniela Meloni, Fabio Olivo, Maria Cavarretta, Daniela Loprevite, Francesco Ingravalle, Valeria Massarotto, Pierluigi Capra, Marilena Gili, Guia Richelmi , Marzia Pezzolato and Maria Caramelli, Istituto Zooprofilattico Sperimentale del Piemonte, Turin, Italy

Analysis of Lead in Commercial Wine Samples by Graphite Furnace Atomic Absorption Spectroscopy
Kydric Smith, Matthew Mireles and Samuel Melaku Abegaz, Department of Chemistry, Columbus State University, Columbus, GA

The Direct Analysis of Volatiles using Fourier Transform Molecular Rotational Resonance (FT-MRR) Spectroscopy
Brent J. Harris, Robin L. Pulliam, Justin L. Neill, Roger Reynolds, Matthew T. Muckle, Dave McDaniel and Brooks H. Pate, BrightSpec, Charlottesville, VA

Qualitative and Quantitative Analysis of Water Soluble Vitamins using UPLC with Selective Mass Detection
Sara Stead, Mark Benvenuti and Jennifer A. Burgess Waters Corporation, Milford, MA

In-Line NIR-based Blend Uniformity Monitoring and Control within Integrated PAT System
Todd Outwin, Sun Pharmaceutical Industries, Inc., Sridhar Valluri, and Umesh Pai; CAMO Software Inc., Brad Swarbrick, Control Associates Inc., Paul Brodbeck; Optimal Industrial Automation, Ltd.: Chris Cox

Development of Continual Mixing Granulator "GTS-MiGRA"
Takuya Nagato, Manager, R&D Department, Technical Division and Koji Hasegawa, Manager, R&D Department, Technical Division, Powrex Corporation, Hyogo, Japan

Implementation of QbD Approach to the Analytical Method Development and Validation for Estimation of Antidiabetic Drugs in Pharmaceutical Dosage Form
Ahmed Ashour, Post-Doctoral Fellow Department of Pharmaceutical Sciences University of Maryland Ahmed Emad Elgendy, Professor,Department of Analytical Chemistry Faculty of Pharmacy Misr International University Ghada Hadad, Assistant Professor, Department of Analytical Chemistry, Faculty of Pharmacy, Suiz Canal University, Rasha Mahmoud Ahmed Assistant Lecturer Faculty of Pharmacy Misr International University, Cairo, Egypt

Fourier Transform Infrared Spectroscopy and Multispectral Image Analysis as means of Assessing the Microbiological Quality of Vanilla Cream
Alexandra Lianou1, Galatios Moschonas1, Ioannis Triantafyllou2, George-John E. Nychas1, Efstathios Z. Panagou1, 1 Laboratory of Microbiology and Biotechnology of Foods, Department of Food Science and Human Nutrition, Agricultural University of Athens, Athens, Greece 2 Hypertech IT Solutions, Athens, Greece

Detection of Minced Meat Adulteration using Multispectral Imaging and Fourier Transform InfraRed (FTIR) Spectroscopy
A.I. Ropodi, D.E. Pavlidis, D. Loukas, E. Z. Panagou and G.-J.E. Nychas, Agricultural University of Athens, Department of Food Science & Human Nutrition, Laboratory of Microbiology and Biotechnology of Foods, Athens, Greece

Quantification of Minced Beef Adulteration with Pork using FTIR Spectroscopy and Partial Least Squares Regression
A.I. Ropodi, D.E. Pavlidis, D. Loukas, E. Z. Panagou and G.-J. E. Nychas, Agricultural University of Athens, Department of Food Science & Human Nutrition, Laboratory of Microbiology and Biotechnology of Foods, Athens, Greece

A Neuro-fuzzy Modeling Approach for the Prediction of Meat Quality
Loukas Dimos, Dimitris Pavlidis, Efstathios Z. Panagou and George-John E. Nychas, Agricultural University of Athens, Department of Food Science & Human Nutrition, Laboratory of Microbiology and Biotechnology of Foods, Athens, Greece

A Comparative Study on Performance of Mid Infrared and Near Infrared Spectroscopy for Liquid Milk
Ole Rasmussen, FOSS, USA, Per Waaben Hansen, FOSS, Denmark, Lars Norgaard, FOSS, Denmark and Dorthe Bisgaard Oldrup, FOSS, Denmark

Authentication of Poultrymeat Storage as Fresh or Frozen by Histology and HADH Activity
Serena Meistro, Fabio Olivo, Katia Varello, Mario Botta, Luca Nocilla, Elisa Baioni, Daniela Meloni and Elena Bozzetta, Istituto Zooprofilattico Sperimentale del Piemonte, Turin, Italy

Development of Characterization Tool for Assessment Nano- sized Materials using Pulsed Field Gradient Nuclear Magnetic Resonance (PFG-NMR)
Haruhisa Kato and Ayako Nakamura, National Metrology Institute of Japan (NMIJ), National Institute of Advanced Industrial Science and Technology (AIST), Tsukuba, Japan

Principal Component Concentration Determination in Osteoarthritic and Healthy Articluar Cartilage by FTIRI and Partial Least Square
Jian-Hua Yin*, Xue-Xi Zhang, Department of Biomedical Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China

HTVS Enabled Raman Spectroscopy for Determination of Olefin, Aromatic and Benzene Content in Gasoline Fuel Blends
Yusuf Bismilla, Tornado Spectral Systems, Mark Kemper, Tornado Spectral Systems, Dr. Leslie M. Tack, Pembroke Instruments, LLC and Marcus Trygstad, Yokogawa Corporation of America

SMART - RIPE - Novel Technology to Improve the Sustainability of the Cheese Ripening Process
Grainne Keena1,2, Ming Zhao2, Donal J O'Callaghan1, Colm P O'Donnell2, B. Perret3, G. Corrieu3, JM Dumontel4, and E. Arch5, 1Food Chemistry and Technology Department, Teagasc Food Research Center, Moorepark, Fermoy, Co. Cork, Ireland, 2Biosystems Engineering & UCD Institute of Food and Health, Dublin, Ireland, 3INRA, Grignon, France, 4C2AP, Pont-du-Chateau, France, 5Innovacio I Recerca Industrail I Sostenible (IRIS), Barcelona, Spain

Mechanistic Investigation of an Active Pharmaceutical Ingredient Utilizing Online NMR Spectroscopy
Anna L. Dunn, Analytical Research and Development, Pfizer Worldwide Research and Development, Groton, CT, USA and Department of Chemistry, University of Wisconsin, Madison, WI, USA, Anna Codina, Bruker UK Limited, Coventry, United Kingdom, David Foley, Analytical Research and Development, Pfizer Worldwide Research and Development, Groton, CT, USA, Brian Marquez, Bruker BioSpin, Billerica MA, USA and Mark T. Zell, Analytical Research and Development, Pfizer Worldwide Research and Development, Groton, CT, USA

Residue Analysis of Orthosulfamuron Herbicide in Fatty Rice using Liquid Chromatography-tandem Mass Spectrometry
So Jeong Im, Chonnam National University, Biotechnology Research Institute, College of Agriculture and Life Sciences, Gwangju, Republic of Korea

Detection of Pyridaben Residue Levels in Hot Pepper Fruits and Leaves by Liquid Chromatography-tandem Mass Spectrometry: Effect of Household Processes
Jae-Han Shim, Chonnam National University, Biotechnology Research Institute, College of Agriculture and Life Sciences, Gwangju, Republic of Korea

Novel Methods for the Improvement of Crystallization in the Food Industry
Terry Redman and Guillermo Smart, Mettler Toledo, Columbia, MD

Methods for the Reduction of Cycle Time in Intermediate Crystallization Steps
Terry Redman and Guillermo Smart, Mettler Toledo, Columbia, MD

Enhanced Bioreactor Observability and Process Guidance Using the Modular Automated Sampling Technology (MAST) Platform and an Integrated Bioprocess Lab Environment
C. Pepper, D. Newbold, D. Hansen, B. Downey and J. Breit (Capsugel, Bend Research, United States)

Chiral Analysis by Fourier Transform Rotational Spectroscopy
Simon Lobsiger, Cristobal Perez, Luca Evangelisti, Kevin K. Lehmann and Brooks H. Pate Department of Chemistry, University of Virginia, Charlottesville, VA

Mathematical Modeling of Two-phase Flow Behavior in a Continuous Tableting Process
Thomas Baxter and James Prescott, Jenike & Johanson, Inc., Tyngsboro, MA

The Evolving Role of Automated Sample Preparation in Support QbD, PAT and Analytical Method QbD in the Pharmaceutical Industry
Robert Houser and Carol Moynihan, SOTAX, Dedham, MA

A QbD Approach to Automated Analytical Method Development for Sample Preparation of Abuse Deterrent Opioid Formulations
Robert Houser, SOTAX, Dedham, MA

Dynamic Behavior and Residual Pattern of Thiamethoxam and its Metabolite Clothianidin in Swiss chard using Liquid Chromatography-tandem Mass Spectrometry
Prof. Jae-Han shim, Chonnam National University, Biotechnology Research Institute, College of Agriculture and Life Sciences, Gwangju, Republic of Korea

Analysis of Benzobicyclon and its Metabolite in Brown Rice and Rice Straw after Field Application using Liquid Chromatography-tandem Mass Spectrometry
So Jeong Im, Chonnam National University, Biotechnology Research Institute, College of Agriculture and Life Sciences, Gwangju, Republic of Korea

An Integrated Lab Environment for Real Time Data Generation and Analysis with a Focus on Cellular, Engineering and Antibody Critical Quality Attributes
Jeffrey Breit, Brandon Downey, Corey Dow-Hygland, Megan Peterson, Brian Russell, Justin Beller, Anthony Quach, Chris Cole and David Lyon, Bend Research, Capsugel Dosage Form Solutions, Bend OR

Portable Raman Spectroscopy for Monitoring Polymorphic Transitions
Katherine A. Bakeev and Philip Zhou, B&W Tek, Inc., Newark, DE

Measurement of Xylose and Glucose for Monitoring Corn Stover Fermentation in Bioethanol Production
Bob Gleason, YSI Life Sciences, Nancy Dowe, National Renewable Energy Laboratory, June Klingensmith, YSI Life Sciences and WilliamMiller, YSI Life Sciences


Tuesday Evening

Evening Discussion Session 2 (5:30PM - 7:00PM)  
Chair(s): Theodora Kourti, GSK


A Proposal for a Drug Product Manufacturing Classification System (MCS) for Oral Solid Dosage Forms
Theme Speaker: Kendal Pitt, GSK


Wednesday AM I

QbD and PAT in the Generic Industry  
Chair(s): Geoffrey Wu, FDA and Inna Ben Anat


Session Overview
This year's session will focus on advances in implementing and managing QbD & PAT in generic industry. Various presentation from industry, academy and the Agency will be included.

Session Introduction - QbD & PAT in Generic Drugs
Geoffrey Wu, FDA, Silver Spring, MD

QbD in the Lifecycle Management of Drug Products: a Regulatory Perspective
Susan Rosencrance, FDA, Silver Spring, MD

QbD in Implementation in Generics: are we there yet? - Industry Perspective
Inna Ben Anat, Teva Pharmaceuticals

Lifecycle Management of Process Analytical Technology Procedures
Marta Lichtig, Taro Pharmaceuticals

Operational Opportunities in Continued Process Validation
Tamar Ben-Avi, Taro Pharmaceuticals

Implementing a QbD Approach to the Development of Generic Transdermal and Topical Products
Mike Fowler, Watson

The Risk-based Review in Generic Drug Application: Bridging the Gap (TBA)
Andre Raw, FDA, Silver Spring, MD

Excipient Quality Risk Management
Brian Carlin, FMC BioPolymer

Q&A
All Speakers


Wednesday AM II

Continuous Manufacturing - I  
Chair(s): Rapti Madurawe, FDA and Theodora Kourti


Continuous Manufacturing-Regulatory Considerations
Rapti Madurawe, FDA, Silver Spring, MD

Modernization of Pharmaceutical Manufacturing in 21st Century - From Batch to Continuous Production
Thomas F. O'Connor, Xiaochuan Yang, Sau L. Lee, Celia Cruz, and Lawrence X. Yu: Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration and Sharmista Chatterjee: Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD

Establishing a Control Strategy for Continuous Processing using Real-time Release
Kelly Swinney, Vertex Pharmaceuticals, Inc., Boston, MA

Considerations for the Implementation of Multivariate Statistical Process Control for Monitoring and Characterizing Continuous Manufacturing Processes
Thomas O'Connor, Sau Lee - Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration and Sharmista Chatterjee - Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, Food and Drug Administration

PAT Developments in Continuous Manufacturing of Pharmaceutical Products
Francisca F Gouveia (a,c), Jesper P Rahbek (b), Asmus R Mortensen (b), Pedro G Felizardo (c), Rasmus Bro (a) a Department of Food Science, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark, b Chemical Production Development, Chemical Production Denmark, Nykoebing Sj., Denmark, c 4Tune Engineering Ltd., Portugal

Use of Multieye, an Online NIR based PAT Solution, for Real Time non Product Content Monitoring of Moisture Content in a Fluidised Bed Granulation/drying and Twin Screw Continuous Granulation Process
Paul Cruise*, Luke Kiernan*, Ian Jones* and Denisio Togashi^, * Innopharma Labs, ^ Dublin Institute of Technology

Real-time Determination of Product Quality and Model Predictive Control of Continuous Manufacturing Systems in a Regulated Environment
Chris McCready, Umetrics/MKS, London, Ontario, Canada

PAT Data Management for Continuous Manufacturing - The Next Generation
Kjell Francois and Ivo Backx, Siemens Industry - Vertical Pharma, Beersel, Belgium

Real Time Monitoring of Granule Blending using Multipoint Near Infrared Spectroscopy
H. Rifai, D.M. Togashi, L., R.Cama, C. Sullivan and P.J. Cullen, Dublin Institute of Technology, Ireland


Wednesday AM III

Fundamental University Research and its Industrial Applications  
Chair(s): Kevin Macias and James Drennen


Process Development on a Continuous Direct Compression System
B. Van Snick a, J. Holman b, J. Vercruyssea, J. Van Renterghem c, A. Kumar d, T. De Beer c, C. Vervaet a, J.P. Remon a, a) Laboratory of Pharmaceutical Technology, Dept. of Pharmaceutics, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, b) Process development center, GEA Pharma systems, Collette NV, c) Laboratory of Pharmaceutical Process Analytical Technology, Dept. of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, d) BIOMATH, Dept. of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent,University, Ghent, Belgium

Design Space Building for Control of Critical Quality Attributes of a Model Monoclonal Antibody
Hemlata Hemlataa, Kurt Brorsonb, Erik Readb, Cyrus Agarabib, Scott Luteb, and Seongkyu Yoona aDepartment of Chemical Engineering, University of Massachusetts, Lowell, MA, USA, bCDER/FDA, Silver Spring MD

Polymer Strip Films as a Robust, Surfactant-free Platform for the Delivery of Poorly Water-soluble Drug Nanoparticles
Scott Krull(1), Ramana Susarla(1), Afolawemi Afolabi(1), Meng Li(1), Ye Ying(2), Zafar Iqbal(2), Ecevit Bilgili(1), Rajesh N. Dave(1), (1)Department of Chemical, Biochemical, and Pharmaceutical Engineering, New Jersey Institute of Technology, Newark, New Jersey, (2)Department of Chemistry and Environmental Science,New Jersey Institute of Technology, Newark, New Jersey

Ultrasound Testing to Measure Mechanical Properties of Tablets in Continuous Manufacturing
Golshid Keyvan, Rutgers University Alberto Cuitino, Rutgers University

University Research: Industrial Application (TBA)
Anik Alam, Duquesne University, Pittsburgh, PA

Open Panel - Fundamental University Research



Wednesday AM IV

Blend Uniformity/Content Uniformity  
Chair(s): Karthik Iyer, FDA and Jim Bergum, BergumSTATS - ISPE


ISPE BUCU Group Output
Jim Bergum, BergumSTATS

Tolerance Interval Approach to Provide Confidence in Passing USP <905>
Jim Bergum, BergumSTATS

Tolerance Interval Approach to Assess Distribution of Dosage Form Assay Values
Buffy Hudson-Curtis, GSK

Comparisons of various Statistical Approaches to Demonstrate CU
Kim Vukovinsky, Pfizer

Bayesian Approach to Assess Content Uniformity
Thomas Parks, Lilly

Retrospective Application of Alternate CU Approaches to Approved Products
Ravi Tejwani, BMS

USP Perspective for the Use of USP <905>
Will Brown, USP

FDA Perspective for Assessing Content Uniformity
Karthik Iyer, FDA

Panel Discussion: BUCU
All Speakers


Wednesday AM V

BioTech - IV: Real Time Monitoring of Bio-Reactors and Bio-Processing  
Chair(s): Cyrus Agarabi, FDA, Michael Tarlov and Kurt Brorson, FDA


Coherent Raman Imaging for Rapid Characterization of Dosage Forms, Cells and Tissues
Marcus T. Cicerone, Biosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, MD

Global Profiling of E. coli Metabolites Using Liquid Chromatography- and Gas Chromatography-Mass Spectrometry
Kelly Telu, Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD

Next Generation Sensors for Bioreactor Monitoring: Going Beyond the Traditional
Govind Rao, Department of Chemical & Biochemical Engineering, Center for Advanced Sensor Technology, University of Maryland, Baltimore County, Baltimore, MD

Unlocking the Bioprocess through the Application of Omics
Jonathan Bones, NIBRT - The National Institute for Bioprocessing Research and Training , Foster Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland

Metabolic Flux Analysis for the Design of Amino Acid Supplementation in Antibody Producing Mammalian Cell Culture
Zhuangrong Huanga, Seoyoung Parka, Kurt Brorsonb, Erik Readb, Cyrus Agarabib, Scott Luteb, and Seongkyu Yoona , aDepartment of Chemical Engineering, University of Massachusetts, Lowell, MA, USA, bCDER/FDA, Silver Spring MD

Investigation of Intracellular Pathway Perturbation Leading to Antibody Glycosylation Variation under Varied Cell Culture Conditions
Sha Shaa, Kurt Brorsonb, Erik Readb, Cyrus Agarabib, Scott Luteb, and Seongkyu Yoona,aDepartment of Chemical Engineering, University of Massachusetts, Lowell, MA, USA, bCDER/FDA, Silver Spring MD

Experimental Application of Design of Experiments and PAT for Biotechnology Manufacturing
Cyrus Agarabi, CDER, FDA

Development of a Process Chemometrics Approach for Real-Time Monitoring and Predicting a Lab Scale Bioreactor Cell Culture Process Metabolites Profiles
Huiquan Wu1, Erik Read2, Maury White1, Brittany Chavez2, Paul Scholl3, Vaso Vlachos3, Kurt Brorson2, Cyrus Agarabi1, Mansoor Khan1, 1Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research (OTR), Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 2Division of Monoclonal Antibody (DMA), Office of Biotechnology Products (OBP), Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 3 Mettler-Toledo Autochem, Columbia, MD


Wednesday AM VI

Screening/Surveillance/Handheld  
Chair(s): Paul DeRose and Paul Vahey


Evaluating the Performance of Field Screening Using Portable Raman and Near Infrared Spectrometers
Jason D. Rodriguez US FDA/CDER/OPS/OTR/DPA, Steven K. Skaggs, US FDA/CDER/OPS/OTR/DPA, Manju M. Johny, US FDA/CDER/OPS/OTR/DPA, Hirsch K. Srivastava, US FDA/CDER/OPS/OTR/DPA, Yvette L. Loethen US FDA/CDER/OPS/OTR/DPA

On-Site Screening of Potentially Dangerous Drug Products Utilizing Ion Mobility Spectrometry
Connie M. Gryniewicz-Ruzicka, FDA,Division of Pharmaceutical Analysis, St. Louis, MO, Kelly J. Park, FDA, Office of Regulatory Affairs, Carson, CA and Katherine Alejo, FDA, Office of Regulatory Affairs, Jamaica, NY

Rapid, Non-Contact Analysis of Surface Bioburden using Deep UV Laser-Induced Native Fluorescence Hyperspectral Imaging
Joanny Salvas3(*), Jean-Sebastien Simard3, Joep Timmermans4(*), Steve Hammond2, Rohit Bartia1, Greg Wanger1, Kripa Sijapati2, Mike Reid2, Prashant Oswal2, Ray Reid2, William Hug2 , 1. Jet Propulsion Laboratory, Planetary Chemistry & Astrobiology Group, Pasadena, CA, 2. Photon Systems Inc, Covina, CA, 3. Process Analytical Sciences Group, Pfizer Canada Inc, Saint-Laurent, Quebec, Canada, 4. Process Analytical Sciences Group, Pfizer Inc, Peapack, NJ, USA

Taking Advantage of Fluorescence Signal in Raman Spectroscopy: Using Fluorescence Profiles to Distinguish Between Finished Drug Products
Yvette L. Loethen (presenter) and Jason D. Rodriguez (FDA/DPA), U.S. Food & Drug Administration/Division of Pharmaceutical Analysis, St. Louis, MO

BRAVO BRUKER - Superior design for Handheld Raman Spectrometers
Florian Eigenmann BRUKER OPTICS, Houston TX (USA), Yan Wang, BRUKER OPTICS, Boston MA (USA), Armin Gembus BRUKER OPTICS, Ettlingen (Germany)

Continuous Manufacturing Tablet PAT Model Development: Lessons Learned
Jenny Vargas Irizarry, Process Development Scientist at Janssen, Gurabo, PR

Open Discussion - All



Wednesday AM VII

Advanced Instruments Concepts  
Chair(s): Darren P. Hydutsky, J. D. Tate, Jason Dickens and Troy Francisco


Online Process Monitoring with the picoSpin NMR Spectrometer
John Frost, Thermo Fisher Scientific, Boulder CO

Evaluation of a Fit-For-Purpose, Miniature NIR Spectrometer for In-line Monitoring of Pharmaceutical Processes
Chi-Shi Chen (1), Pierre Philippe Lapointe-Garant (2), Jean Sebastien Simard (2), Joep Timmmermans (1), Nada O'Brien (3), Chris Pederson (3), Ryan Gosselin (4), (1) Pfizer Inc, Peapack, NJ, USA, (2) Pfizer Inc., Montreal Canada, (3) JDS Uniphase, Milpitas, CA, USA, (4) Universite de Sherbrooke, Sherbrooke, Canada

Integrated Monitoring of Chromatographic Analysis with Orthogonal UV and Mass Spectral Detection
Thomas E. Wheat, Daniel Root and Patricia R. McConville, Waters Corporation, Milford, MA

Selection of Convergence Criteria for Fluorescence Removal Algorithms
Sarah Marshall - Old Dominion University John B. Cooper - Old Dominion University, Norfolk, VA

Sequentially Shifted Excitation Raman Spectroscopy: Enhanced Fluorescence Rejection Using Segmented Post-Processing
Richard W. Jones, Sarah Marshall, and John B. Cooper, Old Dominion University, Norfolk, VA

Advanced Multi-purpose PAT - A new NIR Instrument for Characterization of Dense Media
Yi-Chieh Chen, Strathclyde University, UK and Ke Hong, Senior Manager, AMT, PGS, Pfizer

Quantifying the Composition of Pharmaceutical Tablets using LIBS; the Importance of Matrix Effects
Philip Quinn(1), Ryan Gosselin(1*), Joanny Salvas(2), Jean-Sebastien Simard(2) and Nicolas Abatzoglou(1), 1.Department of Chemical and Biotechnological Engineering, Universite de Sherbrooke, Pfizer Industrial Research Chair, Sherbrooke, Canada, 2. Process Analytical Science Group, Pfizer Canada, Montreal, Canada

Case Study of Possibilities of Industrial Internet in both PAT and Pharmaceutical Industry
Pekka Teppola1, Pasi Hyttinen1, Sini Kivi1, Marko Kaarre1, Mikko Juuti1, Jukka Hast1, Simo-Pekka Simonaho2, Ossi Korhonen2, Jarkko Ketolainen2 and Heikki Ailisto11 VTT Technical Research Centre of Finland, Knowledge Intensive Products and Services, Kuopio, FINLAND, 2 University of Eastern Finland, PROMIS Centre, School of Pharmacy, Faculty of Health Sciences, Kuopio, Finland


Wednesday AM VIII

Chemometrics (COPA) - II  
Chair(s): Christian Airiau, Juergen von Frese and Brian Rohrback


Using COPA for Research & Development (TBA)
Seongkyu Yoon, University Massachusetts Lowell

New and Improved Data Handling and Analysis Strategies for Batch and Continuous Processes
Brad Swarbrick, CAMO Software Inc., Woodbridge, NJ

Using Propagation of Error with Tolerance Intervals to Define a Design Space
Patrick J. Whitcomb (speaker) and Mark J. Anderson, Stat-Ease, Inc., Minneapolis, MN

Quality Assessments for an Organically-Complex Drug - Part 1: Background and the Chemometrics Role
Peter Gibson, GW Pharmaceuticals Ltd., Sittingbourne, Kent, UK

Quality Assessments for an Organically-Complex Drug - Part 2: Detail of the Chemometrics Implementation
Brian Rohrback, Infometrix, Inc., Bothell, WA

Knowing when to Quit: Why do we waste so much time trying to get models out of bad data?
Jeremy Shaver and Barry Wise, Eigenvector Research, Wenatchee, WA

Nonlinear MSPC and Root Cause Analysis with Kernel Methods
Juergen von Frese, Data Analysis Solutions DA-SOL GmbH, Germany

Improving Quality and Compliance through In-line SPC and SCADA Technology
Chris Monchinski and Arlene Weichert, Automated Control Concepts, Inc., Neptune, NJ


Wednesday AM

IFPAC - Food Symposium III: PAT for the Dairy Industry  
Chair(s): Colm O'Donnell, Ph.D., University College, UCD-Dublin Institute of Food & Health, Dublin, Ireland, Brent R. Young, Professor and Head Chemical and Materials Engineering, The University of Auckland, New Zealand and Steve Holroyd, Ph.D., Fonterra Research C


Session Overview
Application techniques, case studies, and the benefits of Implementing PAT for the dairy industry and in infant formula will be presented. Traditional dairy and pharmaceutical approaches and technologies will be discussed, also taking into consideration the nutritional arena.

A Structured Investigation of Real-time Prediction of Milk Powder Functional Properties
B.R. Young (1), N. Depree (1), I. Boiarkina (1), T. Munir (1), D.I. Wilson (2), (1) The University of Auckland, (2) Auckland University of Technology, The University of Auckland, Chemical and Materials Engineering, Auckland City, New Zealand

New Generation FT-NIR Dual Channel Instrumentation for Fast and Accurate Control of Fat, Protein and Homogenizer Efficiency in the Dairy Industry
Florian Eigenmann BRUKER OPTICS, Houston TX, Dean Roberts, BRUKER OPTICS, Madison WI

Multipoint Near-Infrared Spectroscopy for Moisture Content Determination of Powered Infant Formula in Static and Dynamic Conditions
R. Cama 1, Y. Dixit 1, M. Casado 1, T. El Arnaout 1, C. Sullivan 1 P.J. Cullen 1,2 1 School of Food Science & Environmental Health, Dublin Institute of Technology, Dublin, Ireland; 2 School of Chemical Engineering, UNSW, Australia

Potential of Hyperspectral Imaging for Quality Control in Milk Powders
M. Tajammal Munir - Chemical and Materials Engineering, The University of Auckland, New Zealand Wei Yu - Chemical and Materials Engineering, The University of Auckland, New Zealand David I. Wilson - School of Engineering, Auckland University of Technology (AUT), New Zealand Brent R. Young - Chemical and Materials Engineering, The University of Auckland, New Zealand

In-line Analysis of Dairy Products using mid- and Near Infrared Spectroscopy and Chemometrics
Ole Rasmussen, FOSS, USA, Per Waaben Hansen, FOSS, Denmark, Lars Norgaard, FOSS, Denmark, Dorthe Bisgaard Oldrup, FOSS, Denmark, Mads Lykke Andersen, FOSS, Denmark and Jeff Boedigheimer, FOSS, USA

Tryptophan Fluorescence for Dairy Process Control
Fred A. Payne and Michael P. Sama, Biosystems and Agricultural Engineering Department, University of Kentucky, Lexington, KY

Development of PAT Tools for Dairy Processing
Prof. Colm O'Donnell, UCD School of Biosystems Engineering & UCD Institute of Food & Health, Dublin, Ireland

Alps Food Authentication, Typicality and Intrinsic Quality by *Near Infrared Spectroscopy*
Huck-Pezzei Verena A., Seitz, Ina, Karer, Regina, Schutzler, Matthias, De Benedictis, Lorenzo, Wild, Birgit and Huck, Christian W., Fonterra


Wednesday AM/PM

IFPAC Poster Session/Student Poster Day  
Chair(s): Antonio Moreira and Walter Henslee


Posters - Hotel Foyer
See List of Posters Under Tuesday PM


Wednesday PM I

Continuous Process Verification (CPV) - the Ultimate PV Frontier and Continual Improvement Enabler: Practices, Challenges and Opportunities  
Chair(s): Vibhakar Shah, FDA and Ranjit Deshmukh


Session Overview
This session will cover regulatory expectations of and industry perspective on implementing Continued Process Verification (CPV) for new and legacy products, representing both small molecules and biologicals. With some real-life examples and case studies, the session will seek to highlight best industry practices in implementing the CPV program within Firm's Quality system, and leveraging the knowledge gained through CPV program for improvement opportunities under proactive rather than reactive change control management. The session will also discuss some creative approaches in overcoming CPV implementation challenges and advances in Informatics for CPV programs.

Implementation of a CPV Program and How Challenges in Implementation are Addressed
Arne Zilian, Ph.D., CPV Program lead, Novartis Pharma AG, Basel

Continuous Process Verification: Comparison to Continued Process Verification and Case Study of Dryer Optimization
Gretchen Allison, Pfizer, Global Quality and Ke Hong, Pfizer, Advanced Manufacturing Technology

Quality Metrics and CPV
Karthik B. Iyer, Ph.D., (CDER, USFDA)

Industry Case Study: Continued Process Verification (CPV) for a Biotech Product
Bert T. Frohlich, Ph.D., Director Quality-by-Design and Process Controls, MS&T, Shire, Lexington, MA

Panel Discussion (Industry and FDA speakers)
(Arne Zilian, Allison Gretchen, Bert Frohlich, and Karthik Iyer)


Wednesday PM II

Continuous Manufacturing - II: Fundamentals of Manufacturing Science  
Chair(s): Douglas Hausner, Fernando Muzzio and Eric Jayjock


Design of Continuous Manufacturing Systems - a 12 Step Method
Douglas Hausner, Marianthi Ierapetritou and Fernando Muzzio, Rutgers University, Piscataway, NJ

1-D TOS; Variographic Analysis, Measurement Systems and Fit for Purpose Acceptance Levels
Kim H Esbensen* and R.J. Romanach* - Geological Survey of Denmark and Greenland (GEUS) ACABS Research Group, Aalborg University, Denmark ACRG Research Group, Tellemark University College, Norway** - University of Puerto Rico - Mayague

Understanding Process Variation in Continuous Mixing through TOS Variographic Analysis
Rodolfo.J. Romanach*, Andres Roman Ospino*, and Kim H Esbensen*** - University of Puerto Rico-Mayaguez, ** - Geological Survey of Denmark and Greenland (GEUS) ACABS Research Group, Aalborg University, Denmark, ACRG Research Group, Tellemark University College, Norway

Implementing a Robust PAT Solution and Closed Loop Control on a Continuous Manufacturing Plant for the Production of Pharmaceutical Tablets at UPRM
Leonel Quinones-Fontalvo, Chemical Engineering, University of Puerto Rico, Mayaguez Campus, Mayaguez, PR and Carlos Velazquez-Figueroa, Chemical Engineering Department, University of Puerto Rico, Mayaguez Campus, Mayaguez, PR

An In-Line Method for Continuously Monitoring Powder Density
Abhishek Sahay, Ravendra Singh,Andres Roman Ospino, Rodolfo.J. Romanach, Marianthi Ierapetritou, Rohit Ramachandran and Fernando Muzzio, Rutgers University, Piscataway, NJ

Advanced Feed-forward/feed-back Control of Continuous Pharmaceutical Tablet Manufacturing Process
Ravendra Singh, Abhishek Sahay, Marianthi Ierapetritou, Rohit Ramachandran, and Fernando Muzzio, C-SOPS, Chemical and Biochemical Engineering, Rutgers University, Piscataway, NJ, USA

A QbD Study of Continuous High Shear Granulation
Wei Meng, Xue Liu and Fernando Muzzio, Rutgers University, Piscataway, NJ

Experimental and Modeling Study of Powder Segregation in the Feeding Tube of a Tablet Press
Sarang Oka, Dana Barrasso, Abhishek Sahay, and Fernando Muzzio, Rutgers University, Piscataway, NJ

On Line Measurement of Granule Size Distribution During Continuous Wet Granulation using Image Analysis
Ridade Sayin(1), Paul Cruise (2), Ian Jones(2), Laura Martinez(3), Dimitrios Lamprou(3), Jim Litster(1), (1) School of Chemical Engineering, Purdue University, USA, (2) Innopharma Laboratories, Dublin, Ireland, (3) CMAC, Strathclyde University, Scotland


Wednesday PM IV

Quality Metrics  
Chair(s): Russell Wesdyk, FDA and Stephen Tyler, AbbVie - ISPE


ISPE Quality Metrics Pilot Program
Joe Famulare, Genentech

Quality Culture
Speaker (TBA)

Quality Culture
TBD, McKinsey

ISPE Quality Metrics: Definitions
Lorraine McClain, Teva

Quality Metrics: A FDA Perspective
Russell Wesdyk, FDA

Process Capability as a Prioritization Tool of Continual Improvement
Jason J. Orloff, Pharmstat

Panel Discussion



Wednesday PM V

PAT Implementation  
Chair(s): Martin Warman


On-line Analysis of Multivitamin Powder Flows in a Tablet Press
Pedro Palmeiro Durao(1), Nicolas Abatzolgou(1), Jean-Maxime Guay(2) and Ryan Gosselin(1*), 1. Department of Chemical and Biotechnological Engineering, Pfizer Industrial Research Chair, Universite de Sherbrooke, Sherbrooke, Canada, 2. Process Analytical Sciences Group, Pfizer Canada, Montreal, Canada

Experiences with registering Quantitative NIR Methods in Europe
Conor McSweeney, Sonja Sekulic, Mark Smith, Angela Liu and Steve Hammond, Pfizer Global Supply

Evaluation of Protein Titer and Heterogeneity with Multidimensional Chromatography
Sean M. McCarthy, Thomas E. Wheat and Ying Qing Yu, Waters Corp., Milford, MA

Automating Preparation of Chromatographic Mobile Phases LC-UV-MS Monitoring of Chemical Processes
Thomas E. Wheat, Amanda B. Dlugasch and Patricia R. McConville, Waters Corporation, Milford, MA

Softsensor Technology Example - Prediction of Particle Size Distribution after SOD formulation Drying Using Granulation and Drying Process Parameters
David Lauri Pla, Manager, AMT, PGS, Pfizer, Jun Huang, Senior Manager, AMT, PGS, Pfizer and Mojgan Moshgbar, Director, AMT, PGS, Pfizer

Improvement of Iterative Optimization Technology (Calibration-Free/ Minimum Approach) with Dimensionality Reduction of Spectra
Koji Muteki1, Hiromasa Kaneko2 and Kimito Funatsu2, 1 Pfizer Global Supply, Advanced Manufacturing Technology, Groton, Connecticut, United States, 2 Department of Chemical System Engineering, The University of Tokyo, Bunkyo-ku, Tokyo, Japan

The Use of PAT to Optimize Packaging Operations
Steve Hammond, Pfizer Global Supply, Peapack, NJ

In-line Monitoring of Segregation Effects in a Pharmaceutical Tableting Process
Stephan Sacher, Patrick Wahl, Otto Scheibelhofer, Roland Hohl and Johannes G. Khinast, Research Center Pharmaceutical Engineering GmbH, Institute for Process and Particle Engineering, Graz University of Technology, Graz, Austria


Wednesday PM VII

Process Control and Quality  
Chair(s): Walter Henslee


100% Inline Film Thickness Inspection by FormChecker
Dr. Sven Borchert, visiotec GmbH, Laupheim, Deutschland

Achieving Greater Process Understanding through Online Polymerization Reaction Monitoring
Nancy Jestel, Michael Hall, Eylem Tarkin-Tas, Mark Denniston and Carolyn Degonzague, SABIC, Selkirk, NY

Finale Capsule Inspection by VisioAMV
Borchert Sven, visiotec GmbH, Laupheim, Deutschland

From Final Product Tablet Inspection Machines to On-line Analyser Integration Platform Supporting PAT Deployment: How a Lean Engineering Approach has driven Product Development at PRODITEC
Christophe Riboulet, CEO and President, PRODITEC, Pessac, France

Quantitation of Cellular Response Dynamics and Protein Glycosylation during Media Component Fluctuations
Brandon Downey, John Schmitt, Corey Dow-Hygland, Jeffrey Breit, Brian Russell, Justin Beller, Elizabeth Herman, Anthony Quach and David Lyon, Bend Research, Capsugel Dosage Form Solutions, Bend OR

An Integrated Lab Environment for Real Time Data Generation and Analysis with a Focus on Cellular, Engineering and Antibody Critical Quality Attributes
Jeffrey Breit, Brandon Downey, Corey Dow-Hygland, Megan Peterson, Brian Russell, Justin Beller, Anthony Quach, Chris Cole and David Lyon, Bend Research, Capsugel Dosage Form Solutions, Bend OR

Advanced Process Control techniques and their application to the Pharmaceutical Industry
Paul Brodbeck, Control Associates, Allendale, NJ


Wednesday PM VIII

CEMS Technology and Emerging Regulatory Requirements  
Chair(s): Matthew MacConnell


Trace Detection and High Level Corrosives: Mass Spectrometry for Challenging Environmental Analyses
Chuck De Carlo, Industrial Product Manager, Extrel CMS, Pittsburgh, PA

A Simple and Successful CEMS, and Keeping up with the Times
Bruce E. Herman, Technical Specialist, Continuous Gas Analyzers, ABB Instrument Society of America (ISA) Air and Waste Management Association (AWMA) Source Evaluation Society (SES), ABB, Houston, TX

CEMS Applications and Sampling
Bob Bertik, Universal Analyzers, Carson City, NV

Overview of CEMS Technologies and the Advantages and Disadvantages of Each
Don Giel, Regional Sales Manager, Teledyne Monitor Labs, Inc.

CEMS Technology
Matthew MacConnell, Air Products, Allentown, PA

Panel Discussion



Wednesday PM

IFPAC - Food Symposium IV: Food Quality, Safety and Analysis Symposium - Discussion  
Chair(s): P. J. Cullen, Ph.D., Dublin Institute of Technology, School of Food Science and Environmental Health, Dublin, Ireland, Carol Zrybko, Ph.D., Mondelez International, East Hanover, NJ, Michael McCarthy, Ph.D., University of California Davis, Davis, CA, Luis


Food Symposium Wrap-up Discussion - All



Update 25-Jan-2015



Software Version - 2008110702