IFPAC ®- 2008
22nd International Forum
Process Analytical Technology - IFPAC
January 27-30, 2008
Baltimore, Maryland, U.S.A.
Welcome to IFPAC-2008
Partnership for Enhanced Quality & Manufacturing Excellence
TUESDAY, JANUARY 29, 2008
TUESDAY AM - I
QbD -Quality Control Strategies
Chairs: Jim Cheney and Dora Kourti
- Uncertainty in Design Space: The Application of Monte Carlo Methods to Process Modeling
John Kauffman, FDA, Div. of Pharm. Analysis, MO and Jean-Marie Geoffroy, TAP Pharmaceuticals, Lake Forest, IL
- Characterizing the Process Design Space using Multivariate Batch Modeling Methods
Chris McCready, UMETRICS, Kinnelon, NJ
- Implementing a Control Strategy to Provide Practical Implementation of ICH Q8/Q9/Q10
Bruce Davis, Representing ISPE, c/o AstraZeneca, Cheshire, UK
- PAT / Quality by Design and Merging Development and Manufacturing - "Closing the Gap"
Ingrid Maes, Consultant Innovative Technologies, Siemens AG, Zwijndrecht (Antwerp), Belgium
- QbD for Marketed Products (Novartis CRADA)
Author's TBA, Novartis, Suffern, NY
- Quality by re-Design - A QbD Approach to Legacy Products
Line Lundsberg-Nielsen, NNE Pharmaplan, Surrey, UK and Gert Molgaard, Soeborg, Denmark,
- Design Space and Control Strategy for Marketed Products
Theodora Kourti, Senior Technical Director, GlaxoSmithKline
- QbD Panel Discussion-PM
All PM Presenters
TUESDAY AM - II
PAT Applied for Biologics Manufacturing
Chairs: Duncan Low and Adeyma Arroyo
- PAT in Biologics Manufacturing: The Way Forward
Licinia O. Rodrigues, 4TUNE Engineering Ltd., Lisbon, Portugal, Arthur Voogd, Yokogawa Europe BV, AL Amersfoort, The Netherlands and Jose C Menezes, Technical University of Lisbon, Dept Chemical & Biological Engineering, Lisbon, Portugal,
- Implementation of Online Amino Acid Analysis for Medium and Feed Optimization in Mammalian Cell Culture
Polina Rapoport, Szu-Han Wang, Mike Arulgnanendram, Kirin Jamison, Deborah E.Pascoe, Genetech, South San Francisco, CA
- Multivariate Data Analysis Methods for Process Monitoring in a Biotech Pilot Plant
J. Conner, J. Gunther, J. Baclaski, D. Seborg, Amgen, Inc., Thousand Oaks, CA
- At-Sample-Point-Dilution Device for Remote Process Sampling
Authors, TBA, Dionex, Sunnyvale, CA
- PAT during Pharmaceutical Lyophilization: Correlating Product Residual Moisture Content to Water Mass Flux Measurements
William J. Kessler, Kristin Galbally-Kinney and P.A. Mulhall, Physical Sciences Inc., Andover, MA, M.J. Pikal, School of Pharmacy, University of Connecticut, Storrs, CT and Stefan Schneid and Henning Gieseler, School of Pharmacy, Department of Pharmaceutics, Friedrich-Alexander University, Erlangen, Germany
- Quasi-Real Time BioProcess Model Prediction from Optical Loss Measurements
Mark Selker, Finesse Solutions, Santa Clara, CA
- Multivariate Methods for Analysis and Control of Biological Manufacturing Process
Chris McCready, UMETRICS, Kinnelon, NJ
TUESDAY AM - III
NeSSI: the Bus, SAM and Sample Management
Chairs: Jeff Gunnell and Mel Koch
New Sampling and Sensor Initiative (NeSSI)
Since the development of NeSSI started, IFPAC has been a crucial forum for providing updates on current activities as well as identifying the critical next actions. This is accomplished with a mixture of presentations and evening workshops, a format which will be repeated this year.
Presentations will be in two sessions. One (Tuesday AM-III) will focus on the development of the NeSSI-bus and SAM: these are the critical components which will enable the electrification of NeSSI and full connectivity into the control and computing architectures of process plants. The second (Tuesday PM - III) will deal with the increasing range of NeSSI sensors which are coming to market, and the expanding base of end-user experience. Our evening workshop will focus on the steps required to complete commercialisation of an open-standard NeSSI-bus.
- NeSSI - An Enabling Platform for the Reduction of the Total Cost of Ownership of Process Analytical Systems
Peter van Vuuren, Application and Technical Consultant, SpectraSensors Inc./Kaiser Optical Systems Inc.
- Parker IntraflowT and Process Analytics: Deployment Status, Technology Development, and Beyond
Mike Cost, Parker Hannifin
- Process Analyzer Sampling with Astute System
Michel Josseau, EIF Filtres, Montreuil sous Bois, France
- New Intrinsically Safe (IS) Digital Bus Based Controller Area Network (CAN) and Applicability to Integrated Process Gas Chromatography Sample Handling Systems
Tracy Dye P.E., Director of Engineering, ABB Analytics and Patrick Lowery P.E., Director of Product Development, CIRCOR Instrumentation Technologies
- NeSSI-bus Control - An Intrinsically Safe CAN Specification
Richard A. Ales, Swagelok Company, Solon, OH
- Generation 2 Bus Specification Overview
Bob Farmer, Siemens Applied Automation, Bartlesville, OK
TUESDAY AM - IV
Advanced Separations (GC/LC, etc.)
Chairs: John Crandall, Jerry Clemons, and Rick Cooley
Eclectic! Novel! Fast! Advanced!
These words aren't always associated with chromatography. However, these words best describe the 2008 Advanced Separations Symposium at IFPAC. Nearly every mode of chromatography is represented including a revitalization of interest in simulated distillation. Join us for as many sessions as you can. And then be a part of the panel discussion led by process analyzer end users.
- Real-Time Inprocess Analysis Employing New Liquid Chromatography
Technology
Craig Dobbs, Waters
- Going Green: SFC Sets Out to Change the Industry
Rui Chen, Thar Instruments, Inc., Newark, DE
- On-Line Liquid Chromatography: A Key to Unlocking Process Understanding
Rick Cooley and Mike Doyle, Dionex, Bannockburn, IL
- Revolutionary Point-of-Use Micro-Chromatograph with Flexible, Selectable Application Capabilities for Process Industry
Bob Cook, AB Totalflow
- A Case Study of Common Process Applications on a Revolutionary Point-of-Use Micro-Chromatograph
Steve Lake, ABB Toptalflow
- Deethanizer Bottom Analyzer, Sample System, Problems and Solutions
Khalid A. Al-Raihan, Bader M. Al-Braik & Athar Waseem, Analyzer Section, Quality Assurance Department), PETROKEMYA, Jubail, Kingdom of Saudi Arabia
Athar Waseem, Process Analyzer Specialist, Quality Assurance Department.
Arabian Petrochemical Company (PETROKEMYA), Jubail - Saudi Arabia
- Fast On-line Analysis of Reforming Gasoline by Capillary Gas-chromatography - Detail Analysis - Properties Calculation
Franck Baco-Antoniali, Physic and Analysis Direction, Fabrice Bertoncini, Physic and Analysis Direction, Bertrand Marin, Physic and Analysis Direction, Herve Cauffriez, Development Direction, IFP-LYON, Vernaison, France
TUESDAY AM - V
Chemical Imaging: Data Analysis and Emerging Techniques
Chairs: Steve Hammond and Carl Anderson
- Fast Raman mapping of the entire sample surface - is it statistically representative enough?
Eunah Lee, HORIBA Jobin Yvon, Edison, NJ
- Characterizing Near Infrared Chemical Imaging of Pharmaceuticals: Statistical sampling, Depth of penetration, and More
E. Neil Lewis, Janie Dubois, Gerald Sando, Kenneth Haber and Linda Kidder, Malvern Instruments, Columbia, MD
- Chemical Imaging (TBA)
Coulton Legge, GSK
- Applications of terahertz pulsed technology in the pharmaceutical setting
Philip Taday, TeraView Limited, Platinum Building, Cambridge, United Kingd
- Augmenting Spectroscopic Imaging for Analyses of Samples with Complex Surface Topographies
Frank Vogt, University of Tennessee, Knoxville, TN
- Spatial Resolution Targets for Spectroscopic Chemical Imaging
John Kauffman, Sean J. Gilliam, Changning Guo, FDA, Div. of Pharm. Analysis, St. Louis, MO and R. Scott Martin, Department of Chemistry, St. Louis University, St. Louis, MO
- Emerging Analytical Tools - Transmission Raman and Spatially Offset Raman Spectroscopy (SORS) for Rapid Non-invasive Analysis of Pharmaceutical Products
Pavel Matousek, Rutherford Appleton Laboratory, Oxfordshire, UK
TUESDAY AM - VI
The Next Level for Chemometrics and Process Analytics - I
Chair: Brian Rohrback
- The COPA Initiative
Brian G. Rohrback, Infometrix, Inc., Bothell, WA
- Taming the Beast - An Oil Refinery's Comprehensive Approach to Development of FT NIR Calibrations for Refinery Process Streams and Finished Products
Daniel C. Mertens, Tesoro Companies, Inc., San Antonio, TX
- Combining Instrument Standardization and Data Preprocessing: What Methods, and What Order?
Barry M. Wise, Eigenvector Research, Inc., Wenatchee, WA
- Fault Detection in Batch Reactions
Fred Baudais, DuPont, DuET/Measurement Systems Technology, Wilmington, DE
- Scientific Understanding Exactly Defines "Specificity" and "Robustness" in Multivariate Case--Consquences and Opportunities
Ralf Marbach, VTT Optical Instruments Center, Oulu , Finland
- See and Explore Multi-variable Design & Control Spaces with Geometric Process Control
Robin Brooks, Curvaceous Software Limited, Gerrards Cross, Bucks, United Kingdom
- Benefits of Locally Weighted Regression (LWR) for on-line analysis of industrial processes
Larry McDermott, Norman Wright and Martha Ranc, Hamilton Sundstrand, Pomona, CA
TUESDAY PM - I
QbD - Real Time Release
Chair: Dora Kourti
This session discusses the tools and procedures that would be necessary to build up a structure that would lead to Real Time Release.
- Case studies of multivariate data analysis (MVA) as part of PAT in manufacturing environments
Anna Persson, Umetrics, Inc., Kinnelon, NJ
- A Method for Process Understanding Using NIR, IR Spectra, and Chemometrics - For the Effective Process Understanding at Pharmaceutical Process
Masahiro Watari, Yokogawa Electric Corp., Tokyo, Japan
- PAT for Drug Product Processing During the Commercialization Phase of the Product Lifecycle
John Higgins, Nathan Pixley, Mano Ramasamy, Greg Troup, Fan Zhang-Plasket, and Gert Thurau, Merck and Co., Inc., West Point, PA
- Process Analytical Technology (PAT)- A Journey from Reactive to Proactive Pharmaceutical Manufacturing
Barry Gujral, Process Analytical Technology Coordinator, Freeman Stanfield, Manager Analytical Development, Doug Rufino, Senior Director Lab Services, DSM Pharmaceuticals Inc., Greenville, NC
- A Framework for the Development of Design and Control Spaces
Mark-John Bruwer, ProSensus Inc., Hamilton, Ontario, Canada
- The Road to REAL TIME RELEASE
Theodora Kourti, Senior Technical Director, GlaxoSmithKline
- End Point Prediction and Control of Batch BioProcesses
John F.MacGregor, Mark-John Bruwer, McMaster University, Dept.of Chemical Engineering, Hamilton, ON, Canada and Seongkyu Yoon, BiogenIdec, Cambridge, MA
TUESDAY PM - II
New Sensor Technology Applications in Biotechnology
Chairs: Adeyma Arroyo and Duncan Low
- Evaluating the Performance of Different pH Sensor Technologies in Cell Culture Processes
Victor Saucedo, Brad Wolk and Adeyma Arroyo, Genentech, Inc., South San Francisco, CA
- Towards In Situ, Online Optical Measurements of Bioprocesses
Rajeev Ram, Harry Lee, Gustavo Gil, Paolo Boccazzi, Anthony Sinskey,
Elizabeth Bruce, MIT, Cambridge, MA
- MVA for Cell Culture or Downstream
Joydeep Ganguly
- Endosafe PTS
Jeffrey Weber, Pfizer
- Rapid Spectroscopic Methods for Chemometric Classification of Insulins
John Kauffman, Venkat Tumuluri, Connie M. Gryniewicz, and Hongping Ye
FDA, Division of Pharmaceutical Analysis, St. Louis, MO
- 100% Inspection on the Liquid filling Line: Quantitative in-line Determination of API in Insuline Cartridges
Dr. Heino Prinz, Uhlmann VisioTec GmbH, Laupheim, Germany
- Rapid, Simultaneous Monitoring of Multiple Components in Mammalian Cell Culture with Near IR Spectroscopy
Todd Strother, Jeffrey Hirsch, Thermo Fisher Scientific, Madison, WI
- Non-Invasive Biomass Monitor with Wide Linear Range
E. Timothy Davies, University of Georgia, Bioexpression and Fermentation
Facility, Athens, GA and Martin P. Debreczeny, BugLab LLC, Danville, CA
- Evaluation of Integrated Sensor Technologies in a Disposable Bioreactor
Heather Kramer, Derik West and Cory Card, Thermo Fisher Scientific, Logan, UY
TUESDAY PM - III
Nessi: The Toolkit, User Experience and Sensors
Chairs: Jeff Gunnell and Mel Koch
New Sampling and Sensor Initiative (NeSSI)
Since the development of NeSSI started, IFPAC has been a crucial forum for providing updates on current activities as well as identifying the critical next actions. This is accomplished with a mixture of presentations and evening workshops, a format which will be repeated this year. Presentations will be in two sessions. One (Tuesday AM-III) will focus on the development of the NeSSI-bus and SAM: these are the critical components which will enable the electrification of NeSSI and full connectivity into the control and computing architectures of process plants. The second (Tuesday PM - III) will deal with the increasing range of NeSSI sensors which are coming to market, and the expanding base of end-user experience. Our evening workshop will focus on the steps required to complete commercialisation of an open-standard NeSSI-bus.
- Analytical Applications of NeSSI
Dave Veltkamp and Brian Marquardt, Center for Process analytical Chemistry (CPAC), University of Washington, Seattle, WA
- C2V 200: A New Nessi Compatible microGC
Job Elders, C2V, Enschede, The Netherlands
- SP-76 Design for Gas/Air Regulators
Tracy Dye, ABB, Lewisburg, WV
- Real-time In-line Process Monitoring of Liquid Chemical Concentration
David M. Simko, Swagelok Company, Solon, OH
- Process Control of Esterification in a NeSSI-based Micro-reactor by Raman Spectroscopy
Chetan Shende, Frank Inscore and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown,
CT
- NeSSI Compatible Spectroscopic Flow Cells
W. Michael Doyle, Axiom Analytical, Inc., Irvine, CA
- Discussion Session: NeSSI Generation 3: Applications, Analyzers, Sensors
Jeff Gunnell, ExxonMobil Chemical Ltd., Cowdenbeath, Fife, UK
TUESDAY PM - IV
Advanced Separations (GC/LC, etc) - II
Chairs: John Crandall and Rick Cooley
Eclectic! Novel! Fast! Advanced!
These words aren't always associated with chromatography. However, these words best describe the 2008 Advanced Separations Symposium at IFPAC. Nearly every mode of chromatography is represented including a revitalization of interest in simulated distillation. Join us for as many sessions as you can. And then be a part of the panel discussion led by process analyzer end users.
- A Fast Temperature Programmed Process Gas Chromatograph
Jerry M. Clemons Ph. D., Consultant, ABB Process Analytics, Lewisburg, WV
- Advanced Computing for Process Gas Chromatographs
Rajko Puzic, Imperial Oil, Sarnia, Ontario, Canada, Aoshen Wong, Siemens, Bartlesville, OK and Brian G. Rohrback, Infometrix, Bothell, WA
- Fast Chemical Quality Control of VOCs Using Flash GC Technology and
Multivariate Statistical Analysis
Vincent Schmitt, Alpha MOS, Hanover, MD
- Robust Compact GC
David J. Veltkamp, Center for Process Analytical Chemistry (CPAC), University of Washington, Seattle, WA
- Micro Simulated Distillation Gas Chromatography for Refined Products
Carl Rechsteiner, Chevron ETC, Richmond CA
- microGC, fastGC, chemometricGC: What are the interactions and what are the implications for end users and their operations
John Crandall, Khalid A. Al-Raihan, Arabian Petrochemical Company PETROKEMYA), Jubail - Saudi Arabia, John Kutney, Talecris Biotherapeutics, Clayton, NC, Rajko Puzic, Imperial Oil, Sarnia, Ontario, Canada, Carl Rechsteiner, Chevron ETC, Richmond, CA
Tuesday PM - V
Pharmaceutical Imaging - Assessment of Pharmaceutical Quality and Process Understanding
Chairs: Carl Anderson and Steve Hammond
- Assessing Homogeneity using Chemical Imaging
Andrew Brookes, Astra Zeneca
- Complementary Spectroscopic Imaging Methods for Matrix Elucidation
Linda Jayes, Pfizer Ltd., Ramsgate Road, Sandwich, Kent, UK
- Rapid Raman Imaging of Pharmaceutical Tablets Using a Novel Continuous Readout Technique
R. Bennett, T. Smith, I.P. Hayward, Renishaw plc, Gloucestershire, UK
- Imaging of Pharmaceutical Blending for Improved Process Understanding
Carl A. Anderson, James K. Drennen, III, Robert P. Cogdill and Ma Hua, Duquesne University, West Lafayette, IN
- Trace Analysis using Laser Induced Fluorescence (LIF)
Eli Margalith, OPOTEK, Inc., Carlsbad, CA
- Assessment of Pharmaceutical Product Quality Based on Chemical Imaging
Robbe C. Lyon, Ph.D. , Deputy Director, FDA-CDER, Division of Product Quality Research, Silver Spring, MD
TUESDAY PM - VI
Life Cycle Management of Analyzer and Method Reliability
Chairs: Steve Jacobs and Gert Thurau
- Snatching Defeat From the Jaws of Victory...The Human Element in Project Success
Walter Henslee, Editor-in-Chief (J. Process An. Chem.); Scientist, Dow Chemical (retired)
- The Importance of Training on Sample Handling and Conditioning
Author: Mark Firmin; Presenter:Shannon Gregoire, A+ Corporation, LLC, Gonzales, LA
- Economics of Dependability for Analysis Systems
Herbert Hecht and Jeffrey Miller, SoHaR Inc., Culver City, CA
- In-line Mixing End-point Determination of Multi-component Pharmaceutical Products using Process Analyzers/PAT tools
Jean-SEbastien Simard, Process Analytical Techniques & Technologies, Product & Process Development, P.-P. L.-Garant, Wyeth and Universite de Sherbrooke and N. Abatzoglou, Dept of Chemical Engineering, UniversitE de Sherbrooke, Sherbrooke, QC, Wyeth Pharmaceuticals Canada, MontrEal Quebec Canada
- Novel Tool for Searching, Sorting, Copying and Managing Spectra Files for Use in the Development of Individual Discriminate Partial Least Squares (D-PLS) Material Discriminators
James A. Finch, Perrigo, Allegan, MI
TUESDAY - Evening - Session
NeSSI Evening Session
Focus on software and NeSSI applications.
Facilitator: Jeff Gunnell
Poster Session
Chair: Jerry Clemons
- Preparation Evaluation and Characterization of Omeprazole Loaded Eudragit Microspheres
Rakesh H. Goswami, Dr. G K Jani and Dr.M C Gohel, Dr. Renu Jain, L.M. College of Pharmacy, Ahmedabad, India and Torrent Research Center., Ahmedabad, India
- A New Modeling Approach to Performing Raw Material Identification by FT-NIR
Jeremy A Linoski, ABB, Houston, TX
- Process Lab: At-line Analysis for a Process Environment
Jennifer Camarda, Brinkmann Instruments, Inc., Westbury, NY
- Comprehensive and Fully Automated Water Analysis
Heike Risse, Metrohm Ltd., Herisau, Switzerland
- Determination of Alkalinity, pH Value and Total Hardness in Water Samples
Anja Zimmer, Metrohm Ltd., Herisau, Switzerland
- Application of HPTLC and HPLC for the Simultaneous Determination of Ramipril and Valsartan in Pharmaceutical Dosage Form
Nitin Dubey, College of Pharmacy, IPS Academy, College of Pharmacy, Madhya Pradesh, India, Nidhi Dubey, School of Pharmacy, Devi Ahilya University, Madhya Pradesh, India, Jigya M. Patel, A.R.College of Pharmacy, Gujrat, India, Sneha K. Patel, A.R.College of Pharmacy, Gujrat, India, Dr.R.S.Mehta, A.R.College of Pharmacy, Gujrat, India
- Preparation, Characterization and Analysis of Maha Muktashouktic Bhasma
Nitin Dubey, College of Pharmacy, IPS Academy, College of Pharmacy, Madhya Pradesh, India, Nidhi Dubey, School of Pharmacy, Devi Ahilya University, Madhya Pradesh, India, Dr. R.S.Mehta, A.R.College of Pharmacy, Gujrat, India, Dr. A. K. Saluja, A.R.College of Pharmacy, Gujrat, India and Dr.D.K.Jain, College of Pharmacy, IPS Academy, Madhya Pradesh, India
- Simultaneous Size, Shape and Chemical Analysis of Pharmaceutical Granules
Ricardo Vargas, APOTEX Inc., Technical Operations R&D, Toronto, Ontario, Canada, Janie Dubois and E. Neil Lewis, Malvern Instruments, Analytical Imaging Systems, Columbia, MD
- Total reflection X-ray fluorescence (TXRF) analysis: Working
principles, analytical possibilities and restrictions
Hagen Stosnach, Armin Gross, Alexander Seyfarth, Bruker AXS Microanalysis GmbH, Berlin Germany
- Application of Multivariate Curve Resolution in Pharmaceutical Process Understanding
Dongsheng Bu, CAMO Software Inc., Woodbridge, NJ
- Quality Engineering and PAT
Stephen Puryear, Quality Engineer, Novartis Corporation, Emeryville, California
- Using a Configurable Digital Process Controller to Manage Multiple Pressure, Flow, and Process Parameters in Microfluidic Applications
Richard Parker, Parker, Hollis, NH
- In Situ Monitoring of CHO Cell Culture Medium Using Near-Infrared Spectroscopy
Robert Mattes, Applications Scientist, Foss NIRSsystems, Inc., Laurel, MD
Display Wednesday Scientific Program
Registration Form for IFPAC-08
Last updated Thursday, 24-Jan-2008 18:58:21 CST