Plenary Session: IFPAC/QbD/PAT/ONSITE Global Solutions for Process Understanding & Control
Chair(s): Lucinda Buhse, Brian Rohrback, Gert Thurau
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| Welcome, Overview IFPAC-2012 |
| Lucinda Buhse, DPA, OTR, OPS, CDER, FDA St. Louis, MO, Brian Rohrback, Infometrix, Inc., Bothell, WA, Gert Thurau, Merck & Co., Inc., West Point, PA
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| FDA Brings Science to the Forefront (TBC) |
| Janet Woodcock, M.D., Director, CDER, FDA, Silver Spring, MD
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| Technology to Meet the Needs of Patients Around the World |
| Dr. Michael Thien, Senior Vice President of Global Science Technology and Commercialization, Merck Manufacturing Division, West Point, PA
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| EMA Update on QbD and PAT (TBC) |
| Evdokia Korakianiti, Scientific Administrator, Chemicals Quality of Medicines, EMA, UK
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| PAT Answers to Bioprocess, Biomedical and Environmental Questions |
| Professor Govind Rao, Center for Advanced Sensor Technology and Department of Chemical, Biochemical and Environmental Engineering, University of Maryland, Baltimore, MD
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| The Analytical Instrument Role (TBA) |
| Simon Senior, Ph.D., MBA, Director of Marketing for Environmental and Industrial Segments (Instruments), Perkin Elmer
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PAT/RTR Implementation Case Studies-Technical & Regulatory Perspectives - International Consortium for Innovation and Quality in Pharmaceutical Development
Chair(s): Doug Both and George L. Reid
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| This session will discuss case studies on PAT/RTR implementation from Pharma companies. Presentations will provide a current snapshot of how companies approach development and implementation of PAT and RTR with an emphasis on regulatory aspects. This session will explore (1) current applications, (2) the technical base to underwrite the regulatory filing strategy, (3) regulatory agency interactions, (4) associated challenges, including technical, internal and regulatory, and strategies to overcome, (5) measured costs/benefits to implementation, including personnel time, money, and quality |
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| R&D Development Activities in Support of Enabling Real Time Release Testing in the Initial Filing |
| Yang (Angela) Liu, Principal Scientist, Analytical Research and Development, Pfizer
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| Half a Decade of Real-Time Release Testing on a High-volume Product - A Look Back |
| Gert Thurau, Associate Director Analytical Sciences in Development and Supplies, Merck
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| Implementation of PAT for Real Time Release Testing |
| Steve Hammond, Sr. Director/Team Leader, Process Analytical Sciences Group, Pfizer and Mark Smith, Pfizer, Cork, Ireland
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| GSK Learning from Application and Approval of Real Time Release Testing |
| Manish Gupta, Ph.D., Quality by Design and Science Lead, USA, GlaxoSmithKline, Collegeville, PA
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| PAT/RTR: Regulatory Perspective (TBC) |
| Vibhakar J. Shah, Ph.D., Good Manufacturing Practice Assessment, Office of manufacturing and Product Quality (OMPQ), FDA/OC/OMPQ, Silver Spring, MD
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| BMS Learning from the Application and Approval of Real Time Testing |
| David Ziering, Ambarish Singh, Associate Director Global Regulatory Science and Douglas Both Associate Director Biopharmaceutical Process Analytical Science, Bristol-Myers Squibb Company, New Brunswick, NJ
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| Incorporating PAT Methods into Production Recipes for Real Time Release |
| Chris Amstutz, Emerson Process Management, Bradenton, FL
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Raman
Chair(s): Brian Marquardt
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| Quantitative Industrial Raman Spectroscopy: Developments in in-situ Raman Analysis |
| Ian R. Lewis, Kevin Davis, David Strachan, Harry, Owen, Pat Wiegand, Maryann Cuellar, and Sean Gilliam, Kaiser Optical Systems, Inc., Ann Arbor, MI
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| Transmission Raman in Process and Product Development |
| Dr. Mike Claybourn, Horiba Scientific, Villeneuve d'Ascq, France
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| Spatially Offset Raman Spectroscopy: A New Tool for the Non-invasive Identification of Pharmaceutical Raw Ingredients |
| Darren Andrews, Cobalt Light Systems Ltd., Oxfordsire, UK
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| Process RAMAN - Enabling the Pipe-Centric Sampling & Sensor Paradigm |
| Peter van Vuuren, SpectraSensors Inc., Houston, TX
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| Chemometric Modeling and Application for Real-Time Analysis of Ionic Solutions using Raman Spectroscopy |
| Jeremy M. Shaver(1), Sam Bryan(2), Randy Bishop(1) and Matt Edwards2, (1) Eigenvector Research, Inc., (2) Pacific Northwest National Laboratory
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| Retina Safe (1550 nm) Portable Raman Spectroscopy |
| Hermes Huang, Mike Donahue, Stuart Farquharson, Wayne Smith and Carl Broulette, Real-Time Analyzers, Inc., Middletown, CT
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| Feasibility of Utilizing Handheld Raman Spectrometers to Determine API Polymorph in Lieu of PXRD |
| Yong Zhou, Pfizer Inc., Groton, CT
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| Deep Ultraviolet Resonance Raman Spectroscopy in Application of Quality Control of Therapeutic Proteins |
| Sergey Arzhantsev, DPA/OTR/OPS/CDER/FDA, Saint Louis, MO
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| PAT in Early-Phase API Process Development at Amgen |
| Dawn Cohen, Amgen, Thousand Oaks, CA
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| Pharmaceutical API Reaction Monitoring via Raman |
| Robert Wethman, Bristol Myers Squibb Co., New Brunswick, NJ
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| Integration of Continuous Flow Reactors and Raman Spectroscopy for Improved Process Understanding and Control |
| Michael Roberto, Stefan Martin, Charles Branham, Thomas I. Dearing, Wesley, J. Thompson, and Brian J. Marquardt*, Applied Physics Laboratory, University of Washington, Seattle, WA
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Advanced Instrument Concepts
Chair(s): Troy Francisco
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| New Developments in Probes and Systems for High Sensitivity Molecular Spectroscopy |
| W. Michael Doyle, Axiom Analytical, Inc., Tustin, CA
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| New Mid-IR Interferometer Technology |
| Jim Cronin, DuPont, Wilmington, DE
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| A Real-time, Portable Instrument and Platform Which is Able to Identify and Quantify Trace Concentrations of Solvents, Contaminants in Raw Materials, CIP Residues and Adulterants in Packaging Materials Right at the Point of Need: “Field Asymmetric Ion Mobility Spectrometry (FAIMS) By Owlstone.” |
| Steve Freshman, Owlstone, Global Partnership GM
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| Development of LIBS for Industrial Process Control – Perspectives and Examples |
| Steven G. Buckley, Photon Machines, Inc., Redmond, WA
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| New Opportunities in Trace-gas Sensing using Differential Optical Dispersion Spectroscopy (DODiS) |
| Michal Nikodem and Gerard Wysocki, Electrical Engineering Department, Princeton University, Princeton, NJ
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| Design Choices for an FTIR Spectrometer Module Purpose-Built for Industrial Analysis |
| Alex Jacobson, Zvi Bleier, & D. Warren Vidrine, FTRX LLC & Vidrine Consulting, Deer Park, NY
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| Flexible Probes for Process Spectroscopy from UV to Mid IR |
| Dr. Michael Mirakyan, ART Photonics, NY and Viacheslav Artyushenko, ART Photonics, Berlin, Germany
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QbD
Chair(s): Sharmista Chatterjee, Theodora Kourti and James Cheney
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| QbD Approach to Optimizing API Properties and Processing Parameters in Roller Compaction Preliminary Market Formulation |
| Johnson, M.A.*, Sharon, L., Margelefsky, , E.L., Algayer, K.N., Senderak, E.T., Eichman, J., Wong, G.S., Xie, L., Maher, T.K., Andrews and R., Hardy, I.J., Merck, West Point, PA
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| QbD: A Case-study from an Industrial Pharmaceutical Fluid Bed Granulation |
| Vera Lourenco (a), Thorsten Herdling (b), Dirk Lochmann (b), Gabriele Reich (c), José C. Menezes (a), Jens Schewitz (b), (a) Institute of Biotechnology and Bioengineering, IST, Technical University of Lisbon, Portugal, (b) Quality Operations, PAT - Laboratory, Merck Serono, Darmstadt, Germany, (c) Institute of Pharmacy and Molecular Biotechnology, University of Heidelberg, Germany
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| Development and Implementation of Innovative, Risk-based Control Strategies Under QbD Framework |
| W. Mark Eickhoff, Merck Sharp & Dohme, West Point, PA
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| Whole Process Analysis within the QbD Framework |
| Joao Espiga Machado, Juergen von Frese, 4tune Engineering Ltd, Data Analysis Solutions, Lisbon, Portugal
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| De-risking Scale-up of a High Shear Wet Granulation Process Using Latent Variable Modeling and Near Infrared Spectroscopy |
| Koji Muteki, Ken Yamamoto, George L. Reid and Mahesh Krishnan, Pfizer Inc., Groton, CT
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| Commercial Site Implementation of QbD: Two Opposing Realizations of Process Control to Ensure Quality |
| Omar Sprockel, Bristol-Myers Squibb, New Brunswick, NJ
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| Importance of More Flexible use of PAT in a Japanese Pharmaceutical Society |
| Wataru Momose, Astellas Pharma Inc. and PAT committee of Japan Society of Pharmaceutical Machinery and Engineering (JSPME), Yaizu-shi, Japan
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| Roll-out of a PAT drying application to four sites: Achievements, surprises and lessons learned |
| Lorenz Liesum, Novartis, Basel, Switzerland
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| How does Continuous Process Validation Drive Product performance Monitoring and Understanding Variability? |
| Richard Kettlewell, Global Director of Validation and Lifecyle Management, GSK
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BioReactors
Chair(s): Kurt Brorson, Michael Tarlov and Steve Kozlowski
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| Bioreactor Introduction and Overview |
| Kurt Brorson, FDA, Silver Spring, MD
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| The International Community's Effort to Sequence and Maintain the CHO Genome |
| Kelvin H. Lee, University of Delaware Biotechnology Institute, Newark, DE
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| Quantitative Analysis of Cell Culture Media using Raman Spectroscopy |
| Dr. Alan G. Ryder, Nanoscale Biophotonics Laboratory, School of Chemistry, National University of Ireland Galway, Galway, Ireland
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| Process-sensitive Sentinel Genes as Novel Cell Culture Comparability Metrics |
| Bhargavi Kondragunta1,2, Bharat H Joshi2, Jing Han2, Kurt A. Brorson3, Raj K. Puri2, Antonio R. Moreira1 and Govind Rao1, 1Center for Advanced Sensor Technology and Department of Chemical, Biochemical and Environmental Engineering, University of Maryland, Baltimore County, Baltimore, MD, 2Division of Cellular and Gene Therapy, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 3Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
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| The Effects of Process Conditions on Productivity, Cell Physiology, and Protein Glycosylation for Cultured Mammalian Cells |
| Susan Sharfstein, University at Albany, College of Nanoscale Science and Engineering, Albany, NY
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| High Resolution Gas Phase Ion Mobility for Monitoring Protein Stability and Aggregation: Different Case Studies |
| Suvajyoti Guha1,2, Joshua R. Wayment2, Mingdong Li1,2, Vinayak Rastogi2, Erik Read3, Kurt R. Brorson3, Michael J. Tarlov2, Michael R. Zachariah1,2, 1University of Maryland, College Park, MD, 2National Institute of Standards and Technology, Gaithersburg, MD, 3Food and Drug Administration, Silver Spring, MD
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| CDER PAT Work (TBA) |
| Erik Read, CDER, FDA, Silver Spring, MD
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| When is often too often but not often enough: Online Quantitative Bioreactor Analytics |
| Craig Dobbs, Waters Corp., Milford, MA
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| PAT Applications for Recombinant Protein Product Quality Control |
| Veronica Carvalhal, Genentech, Inc., South San Francisco, CA
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| Developing Scale-Independent NIR Calibrations for PAT Monitoring of Mab Cultivations during Process Development and Manufacturing |
| Christian Hakemeyer1, Silke Werz1, Jose C Menezes2, Francisca Folque3, Ulrike Strauss1, (1) Pharmaceutical Biotech Production & Development, Roche Diagnostics GmbH, Penzberg, Germany, (2) Institute for Biotechnology and Bioginnering, IST - Technical University of Lisbon, Portugal, (3)Technology Services & Products, 4Tune Engineering Ltd, Lisbon, Portugal
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Control Strategies for Drug Development & Manufacturing
Chair(s): Tim Stevens, Ruben Lozano, and Kevin Macias
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| In-Line Monitoring and Control of a Fluid Bed Dryer by FT-NIR |
| Chris Heil, Thermo Fisher Scientific, Madison, WI
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| The Agile Quality Management System |
| Siegfried Schmitt, PAREXEL, Essex, UK
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| Implementation of PAT to Examine the Role of Roller Compaction and Tablet Compression Parameters on Critical Quality Attributes of a Solid Dosage Form |
| Claudia C. Corredor, Kevin Macias, Ruben Lozano, Anthony Tantuccio, Tim Stevens, and Douglas Both. Analytical and Bioanalytical Development, (ABD), Bristol-Myers Squibb, New Brunswick, NJ
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| Bi-layer Tablet Assay by Reflectance NIR - Development and Implementation |
| Licinia Rodrigues, Bruce T. Thompson, Peter McGuigan, Gert Thurau and John Carolan, Merck
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| Control: The Challenging Opportunity |
| Ali M. Afnan, Step Change Pharma, Inc., Olney, MD
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| Real-time Process Management for Continuous Production in Pharmaceutical Manufacturing |
| Arun Giridhar, Girish Joglekar, Laura Hirshfield, Anshu Gupta, Venkat Venkatasubramanian, Gintaras V. Reklaitis, Purdue University, West Lafayette, Indiana
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| In-line measurement solutions for controlling continuous pharmaceutical manufacturing; case studies of wet granulation and drying |
| Juuti Mikko, VTT Technical Research Centre of Finland, Oulu, Finland
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| PAT and Quality by Design Tools Integration with Automation System in Manufacturing |
| Jorge Costa, Hovione FarmaCiencia SA, Loures, Portugal
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| RTR-Enabling Drug Product Control Strategy: Opportunities for PAT Implementation |
| Ajit Narang, Bristol-Myers Squibb, Co., New Brunswick, NJ
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NeSSI – I
Chair(s): Mel Koch and Tom Dudley
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| The session will include an introduction and history of NeSSI™ and its potential value of enhancing process monitoring and control. There will be talks on the status of the NeSSI™ platform presented by representatives of the NeSSI™ platform manufacturers. The importance of communicating the performance of devices on the NeSSI™ platform to the corresponding process control system will be emphasized in presentations by engineering companies addressing this topic. In addition there will be presentations that highlight how NeSSI™ has enhanced various industrial and academic operations, from discovery to process control. The development of analytical tools for use on or with NeSSI™ will be addressed, as well as how these analytical tools enable effective use of chemical flow reactors and bio-reactors. There will be a discussion period based on the perspectives of process analyzer systems based on micro approaches and how the value is being demonstrated in the use of NeSSI™ in realizing the potential of the exciting advances in measurement and connectivity. |
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| Introduction to the NeSSI™ Platform and an Update on Recent Activity involving the Initiative as it Progresses from Generation I to Generation III |
| Mel Koch, Applied Physics Lab/CPAC, University of Washington, Seattle, WA
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| Evolving Applications that Demonstrate the Value of the NeSSI™ Platform |
| Tom Dudley and Mike Cost, Parker – Hannifin
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| End User Based Studies that Address the Cost of Ownership of the NeSSI™ Platform |
| Doug Nordstrom, Swagelok, Solon, OH
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| Network Issues Affecting Future NeSSI Generations |
| Bob Farmer, Siemens Industry, Inc., Bartlesville, OK
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| The status of Generation II involving the use of the NeSSI™ Platform and Process Analytical Technology (PAT) |
| David Faulkner, Astute
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| Bootstrapping Your Way to an Automated Sample System |
| Stephen Jacobs and Stephen Horgash, Eastman Chemical Company, Kingsport, TN and Andrew Creque, Swagelok, Highland Heights, OH
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| The use of NeSSI™ in Development and Production Activities |
| Carl Rechsteiner and Don Nettles, Chevron, Richmond, CA
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| Technology Enabling the Realization of NeSSI™ Gen 111 |
| David Faulkner, Astute (TBC)
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Chemometrics - I
Chair(s): Karen Bloch and Brian Rohrbach
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| Chemometrics at The Dow Chemical Company |
| Mary Beth Seasholtz, Randy Pell, Zdravko Stefanov, Dow Chemical Co., Midland, MI
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| Bayesian Inference based Two-stage Support Vector Regression Method for Soft Sensor Development of Batch Processes |
| Jie Yu, McMaster University, Hamilton, Ontario, Canada
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| Surrounding and Solving an Analytical Problem with Data Fusion |
| Thomas I. Dearing, Applied Physics Laboratory - University of Washington, Seattle, WA
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| Application of Target PLS for Batch Process Monitoring in the Near Infrared Region |
| Boiana Budevska, DuPont
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| Process Analytical Technologies and Smart Chemometrics in Rapid Scale Up |
| Dr. Ornella Preisner, Newcastle University, School of Chemical Engineering and Advanced Materials, Newcastle upon Tyne, UK and Centre for Process Analytics and Control Technology and Professor Julian Morris, Newcastle University, School of chemical Engineering and Advanced Materials, Newcastle upon Tyne, UK
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| A Robust Computational Approach for Recognition and Quantification of Biomarkers using Multi-dimensional Data Streams |
| Phillip H. Rogers, Kurt D. Benkstein, and Steve Semancik, National Institute of Standard, Gaithersburg, MD
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| Use of Spatial Distance and Clustering Methods for In-line Diagnostic of Outlier Detection |
| Yleana M. Colon, University of Puerto Rico – Mayaguez, Mayaguez, PR
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| A Multivariate approach to Data Mining and Data Integration |
| Petter Moree, Director, On-Line Products, Umetrics AB, Malmo, Sweden
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| Accurate Non-Linear Modeling with Support Vector Machines |
| Juergen von Frese, Data Analysis Solutions, Greifenberg, Germany
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Advanced Separations I
Chair(s): John Crandall
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| Introduction/Opening Remarks |
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| A Comprehensive Systems Approach that increases Process Development Efficiencies and Enabling a Direct Link to Manufacturing Implementation |
| Ernie Hillier, Sr. Product Marketing Manager Patrol, Waters Corp., Milford, MA
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| Applications of Plug & Play Pre-Engineered Column Trains |
| Robert L. Cook, Operations Analyst, ABB
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| Fast Analysis of Syngas using a Micro-Machined Gas Chromatograph System with a Thermal Conductivity Detector |
| Debbie Hutt, Technical Support Engineer Sensors, Systems and Control, INFICON, Inc., East Syracuse, NY
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| Low Thermal Mass (LTM) GC Technology for High Performance Rapid Analysis |
| Roger L. Firor, Agilent Technologies, Wilmington, DE
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| Not Just for Simulated Distillation: Broadly Applicable Fast GC |
| Ned Roques, John Crandall and Steve Bostic, Falcon Analytical, Ronceverte, WV
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| Simulated Distillation: Not just for Carbon |
| Carl Rechsteiner, Chevron Energy Technology Co., Richmond, CA
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| Volatile Chemical Waste Component Measurements in Marine Fuel (bunker) Oil Using a Novel Micro-Channel Active Splitting Wafer Device and GC/MS |
| Andrew Tipler and Heidi Grecsek, PerkinElmer Inc.
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Emerging Technologies with Focus on Traceability and Contamination
Chair(s): Carol Zrybko, Ph.D., Kraft Foods and Michael McCarthy, Ph.D., University of California, Davis
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| Evolution of Compendial Testing Standards for Food Ingredients to Guard Against Economically Motivated Adulteration |
| Jeffrey C. Moore, Ph.D., Senior Scientific Liaison to the Food Chemicals Codex, U.S. Pharmacopeial Convention (USP)
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| New GC/MS Techniques for the Analysis of Small Molecule Contaminants in Food |
| Philip L. Wylie, Agilent Technologies, Wilmington, DE
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| Fingerprinting Food Ingredients for Food Authentication by Vibrational Spectroscopy Technologies |
| Luis E. Rodriguez-Saona, The Ohio State University, Columbus, OH
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| Multiplex Serotyping and ID of Food-borne Pathogens by MS: A Validation Study |
| Lenore Kelly, Agilent
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| Edible Oil Analysis by FT-NIR Spectroscopy |
| Herman He, Michelle Pressler, Thermo Fisher Scientific, Lanham, MD
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| Recent Advances in Reducing Time-to-Results for Detection of Listeria, E. coli, and Salmonella: From Rapid Enrichment to Immunomagnetic Capture |
| Rich Ozanich, Becky Hess, Janine Hutchison, Kristin Victry, Li Zhang, Rachel Bartholomew and Tim Straub, Chemical and Biological Signature Sciences Group National Security Directorate, Pacific Northwest National Laboratory, Richland, WA, USA Battelle, Pacific Northwest Division
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| Approaches to Detecting Adulteration of Food Ingredients at Kraft |
| Dr. Carol Zrybko, Kraft Foods, East Hanover, NJ
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| Contamination of Food Products (TBA) |
| Michael McCarthy, Ph.D., University of California, Davis
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PAT Approaches for Continuous Manufacturing
Chair(s): Fernando J. Muzzio
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| Continuous manufacturing processes are currently the focus of substantial interest by the pharmaceutical industry. Due to the need to control every processing step simultaneously and continuously, they pose also substantial new challenges in process monitoring and control. In this session, we welcome contributions that demonstrate effective use of PAT methodologies for all aspects of continuous processing, including both drug substance and drug product manufacturing. |
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| Prospects for Continuous Manufacturing of Biomolecules |
| Mauricio Futran, Rutgers University, Piscataway, NJ
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| Model-based Control of an Integrated and Continuous Downstream Pharmaceutical Process |
| Rohit Ramachandran, Rutgers University, Piscataway, NJ
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| Characterization of Pharmaceutical Tablets Produced by Continuous Direct Compression Tableting Process using Chemical Imaging as a PAT Tool |
| Kristiina Järvinen*, Janne Paaso#, Maiju Järvinen*, Maunu Toiviainen#, Csaba Finta#, Pekka Teppola#, Sami Poutiainen*, Janne Suhonen#, Fernando Muzzio¤ and Mikko Juuti#* University of Eastern Finland, Kuopio, Finland; #VTT Technical Research Centre of Finland, Finland; ¤Rutgers University, Piscataway, USA
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| Development of a Real Time NIR Method for Drug Concentration in an Industrial Continuous Powder Mixing Process |
| Rodolfo J Romanach, UPR-Mayaguez, Department of Chemistry, Mayaguez, PR
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| Dynamic Flowsheet Simulation of Integrated Continuous Pharmaceutical Manufacturing |
| Fani Boukouvala, Rohit Ramachandran, Fernando Muzzio, Marianthi Ierapetritou Rutgers University, Department of Chemical and Biochemical Engineering, Piscataway, NJ
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| Case Study on an Existing Continuous Wet Granulation and Drying Systems |
| Ralf Kretzschmar, Glatt Systemtechnik GmbH, Dresden, Germany
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| Addressing Material Properties in the Design of Direct Compression Continuous Manufacturing Systems |
| Fernando J. Muzzio, Rutgers University, Piscataway, NJ
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PAT Applied for Biologics Manufacturing
Chair(s): Jose C. Menezes and Ranjit R. Deshmukh
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| Predicting MAb Product Yields Using Near-Infrared and 2D-Fluorescence Spectra of Cultivation Media Components |
| Ulrike Strauss, Silke Werz, Christian Hakemeyer, Roche Diagnostics GmbH - Pharmaceutical Biotech Production & Development, Penzberg, Germany, Gledson E. Jose, Francisca Folque, 4TUNE Engineering Ltd, Lisbon, Portugal and Jose C. Menezes, IBB-Institute for Biotechnology and Bioengineering, IST-Technical, University of Lisbon, Av. Lisbon, Portugal
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| Combination of Spectroscopic Methods for Inline-monitoring and Control of Mammalian Cell Cultivations |
| Stefan Buziol, Roman Greppmair and Rainer Mueller, Roche Diagnostics GmbH, Penzberg, Germany, Pedro Felizardo, M. Joana Mendes and Francisca Folque, 4TUNE Engineering Ltd, Lisbon, Portugal and Jose C. Menezes, IBB-Institute for Biotechnology and Bioengineering, IST-Technical, University of Lisbon, Lisbon, Portugal
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| Implementation of Real-Time MVDA as a Platform PAT Tool for Vaccines and Biologics |
| John Higgins, Louis Obando, Gert Thurau, and Eric Ahuja, Global Science, Technology, and Commercialization, Merck Manufacturing Division, Merck and Co., Inc., West Point PA
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| Monitoring Bispecific Assembly Reactions with On-Line Raman Spectroscopy |
| Michael Milligan, Genentech, South San Francisco, CA
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| Process Analytical Technology Development Plan for a Biopharmaceutical Company |
| David Heaps, Analytical Biochemistry, MedImmune, Gaithersburg, MD
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| An In-Situ, Robust, Optical Glucose Sensor for Biopharmaceutical Process Analysis |
| Greg Emmerson, Sam Watts, and George Barringer, Stratophase Ltd., Romsey, UK
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| Optimization of Bioprocess Solid-Liquid Separations Using Process Analytical Technology (PAT) |
| Benjamin Smith, Mettler Toldeo, Columbia, MD
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| Near-infrared Spectroscopy for In-line Monitoring Unfolding and Interactions with Lyoprotectants during the Freeze-drying of Proteins |
| De Beer Thomas, Ghent University, Ghent, Belgium
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NeSSI – II: Micro-Analytical for NeSSI™ (Examples of Applications Where NeSSI™ has Enabled Process Understanding in Both Laboratory and Production Environments.)
Chair(s): Mel Koch and Tom Dudley
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| Enabling Generation III of NeSSI™ by interfacing Measurement Science to the Generation I Platform (one hour slot) (Topics to include new sensors, micro-reactors, bio-reactors, and data handling advances) |
| Brian Marquardt, Applied Physics Lab and CPAC, University of Washington, Seattle, WA
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| Liquid injection valves testing for microGC adaptation - Comparison between HPLIS and ROLSI |
| Ramy Abou Naccoul*, Ylane Malicet*, Ilham Mokbel*, Ronan Cozic** and Jacques Jose*, *Claude Bernard University, Villeurbanne, France; **S.R.A. Instruments, Marcy L’etoile, France
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| Useful Applications of Smart micro Gas Chromatography with the NeSSI Platform |
| John Crandall, Falcon Analytical, Mike Cost, Parker and George Schreiner, Justice Laboratory Software
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| Sample Systems as a Control Element |
| Michael Hoffman, Siemens, Montgomery, TX
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| Panel Discussion on How the Technical Advances related to Enabling NeSSI™ have Shown Value and are Addressing the Challenges to Implement NeSSI™ Platforms in the Marketplace |
| Mel Koch and Brian Marquardt, APL / CPAC, University of Washington and selected panel members
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Imaging - II
Chair(s): Steve Hammond and Carl Anderson
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| XRF Hyperspectral Imaging (TBA) |
| Eunah Lee, Horiba Jobin Yvon
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| A New Approach to the Chemical and Physical Characterization of Pharmaceutical Particles - QbD of a Dry Powder Inhaler Formulation |
| Linda H. Kidder, E. Neil Lewis, Gerald Sando and Kenneth S. Haber, Malvern Instruments, Inc., Columbia, MD
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| Applications of Raman microscopy to Pharmaceutical Development |
| Dr. Shen Yung Luk, Chief Scientific Officer, Molecular Profiles Ltd., Nottingham, UK
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| Morphologically-Targeted Spectroscopy in Pharmaceutical Product Development |
| Justin Pritchard and Martin Warman, Vertex Pharmaceuticals, Cambridge, MA
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| Data Mining in Data Fusion – Combining Complimentary and Reconciling Competitive Technologies |
| Jeremy Shaver1, Eunah Lee2, Karen Gall2 and Andrew Whitley2,1Eigenvector Research Inc., Wenatchee, WA, 2HORIBA Jobin Yvon Inc., Edison, NJ
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| Using Wavelet Texture Analysis to Determine Bulk Powder Particle Size |
| Ryan Gosselin1*, Marc-Olivier Lacombe11. Université de Sherbrooke, Department of Chemical & Biotechnological Engineering, Québec (Qc), Canada
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Chemometrics - II
Chair(s): Karen Bloch and Brian Rohrbach
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| 18 Fuel Properties Determined in 3 Minutes by Raman Spectroscopy |
| Carl Bruoillette, Frank Inscore, Mike Donahue, Stuart Farquharson and Wayne Smith, Real-Time Analyzers, Inc., Middletown, CT
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| Mutivariate Analysis of 1H and 13C NMR Data of Residual Catalytic Cracker Feed-Streams: NMR Pre-Processing Strategies that Allow the Development of Predictive Models of Physical and Chemical Properties that are Independent of NMR Instrument Magnetic Field Strength |
| John Edwards, Process NMR Associates, Danbury, CT
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| Chemometrics for Routine Processing of LIBS Data – Methods for Dealing with Large Data Sets |
| Steven G. Buckley1, Christopher B. Stipe2, and Gregg A. Lithgow1 ,1Photon Machines, Inc., Redmond, WA, 2Department of Mechanical Engineering, Seattle University, Seattle, WA
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| Application of Chemometric Techniques to Heparin Purity Analysis and Quality Control using Proton NMR Spectral Data |
| William J. Welsh, UMDNJ Robert Wood Johnson Medical School, Department of Pharmacology, Piscataway, NJ
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| Effect of Blend End-point Algorithms on Blend Homogeneity |
| Benoit Igne, Duquesne University, Pittsburgh, PA
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| Missing Data: Making the most of what you don’t have |
| Jeremy M. Shaver and Barry M. Wise, Eigenvector Research, Inc., Wenatchee, WA
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| “30 Years of Chemometrics” |
| Fred Fry and Sara Handy, FDA, CFSAN, College Park, MD
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Food Safety in the Context of Growing Imports
Chair(s): Janie Dubois, Ph.D., University of Maryland, JIFSAN
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| Challenges in Development of Melamine Analysis in Food Contamination |
| Alexander J. Krynitsky, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Regulatory Science, College Park, MD
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| Detection of DEHP, Melamine, and Pesticides in Liquid and Solid Food Samples by SERS |
| Chetan Shende, Frank Inscore, Atanu Sengupta, Hermes Huang and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown, CT
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| Pesticide Residue Analysis (QuEChERS, LC and GC-MS) |
| Dr. Jon Wong, FDA, CFSAN, College Park, MD
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| FSMA and what is Might Mean for Domestic and International Food Processing Plants in Terms of Changes to Testing Requirements |
| Dr. Timothy McGrath, FDA, ORA, Rockville, MD
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| Foodborne Pathogen Analysis by SERS |
| Atanu Sengupta, Chetan Shende, Hermes Huang, Stuart Farquharson and Frank Inscore, Real-Time Analyzers, Inc., Middletown, CT
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| Food Safety Programs |
| Janie Dubois, Ph.D., University of Maryland, JIFSAN
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Continuous Manufacturing
Chair(s): Vibhakar Shah, Theodora Kourti and James Cheney
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| Regulatory Perspective on Continuous Manufacturing |
| Sharmista Chatterjee, FDA, Silver Spring, MD
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| Transforming Existing Batch Processes to Continuous Process in the Pharmaceutical Manufacturing Company at Puerto Rico (a Case Study) |
| Eric J. Sanchez-Rolon, Janssen Supply Chain, Gurabo, PR
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| Interfacing PAT Instruments to Continuous Processing Equipment |
| Stephen Hammond, Pfizer, Peapack, NJ
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| Continuous Processing and 100% NIR Inspection in Pharmaceutical Processes |
| Dr. Sven Borchert, Senior Consultant & PAT, Uhlmann VisioTec, Laupheim, Germany
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| Applying NIR based PAT to Continuous Solid Dose Production |
| Sebastian Sowinski, Sentronic GmbH, Dresden, Germany
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| Ultrasound as a PAT Tool for Monitoring Mechanical Properties of Tablets |
| Simo-Pekka Simoanho, University of Eastern Finland, Kuopio, Finland
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| On-line HPLC for Continuous Reaction Monitoring and Process Control |
| Todd Maloney, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
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| Demonstration of a Pharmaceutical Hot Melt Extrusion Process with SIPAT |
| Barbara Kavsek, Siemens, Vienna, Austria
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| Continuous Manufacturing Round Table |
| All
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Bio Processing
Chair(s): Ron Hoffman
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| Characterization of a Robust Optical Oxygen Sensor for Bioprocess Analysis |
| Charles W. Branham1, Lauren Hughs1, Kent Mann2, and Brian Marquardt1, University of Washington1, University of Minnesota2, Applied Physic Laboratory, University of Washington, Seattle, WA
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| Inline Real-Time Near-Infrared Measurements for Process and Quality Control in Batch Reactors in Emulsifier Production |
| A. Lindahl, Danisco A/S, Grindsted, Denmark
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| Integrated DoE for Benchtop Bioreactors |
| Falk Schneider and Dr. Karl Rix, DASGIP Biotools, Shrewsbury, MA
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| Monitoring Biodiesel Production: From Lab to Plant |
| Mike Donahue, Stuart Farquharson and Wayne Smith, Real-Time Analyzers, Inc., Middletown, CT
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| A New Gaussian Mixture Model Based Bayesian Inferential Monitoring Technique for Complex Chemical and Biological Processes |
| Jie Yu, McMaster University, Department of Chemical Engineering, Hamilton, Ontario, Canada
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| PAT and its Role in Real-time Optimization and Control of Bioreactors |
| M.J. Bruwer, J.F. MacGregor, I. Miletic, D. Pieters , ProSensus, Inc., Ancaster, Ontario, Canada
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| NMR Analysis of Cell Culture Fluids |
| Scott Bradley and Andreas Kaerner, Eli Lilly, IN (TBC)
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Pharmaceutical Product Performance: Expected and Actual
Chair(s): Jean-Marie Geoffroy
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| This session will discuss the value in estimating and monitoring pharmaceutical product performance. Raw material and process parameters are investigated during the development phases of a project, and the knowledge obtained is refined as experience is gained throughout the lifecycle of the project. This session will 1) explore process model’s developed at small scale and their usefulness at predicting quality (performance) at small and large scale, and 2) investigate how modeling of the variation in quality (e.g. standard deviation), in addition to standard process models, can enhance prediction of commercial product performance. It will be shown that the latter can be useful in not only setting appropriate specifications based on process capability but also in predicting process capability of commercial lots. |
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| Application of Small-Scale Statistical Designed Experiment for Large-Scale Quality Quantification and Assurance |
| Ke Wang, WWPS - PGS Statistics, Pfizer Inc., Jason Mustakis, CRD, Pfizer Inc., Peter Rose, CRD, Pfizer Inc.
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| Particle Size Reduction Studies on the Lab and Commercial Scale Using High and Low Energy Mills |
| Bei Chen, Abbott
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| Expected vs Predicted; Parametric Release vs RTR? |
| Martin Warman and Kelly Tolton, Director Tech Ops, Vertex Pharmaceutical, UK
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| Evaluation of Process Models with Monte Carolo Methods |
| John F. Kauffman,Silver1 Sharmista Chatterjee 2 and Jean-Marie Geoffroy3, 1. FDA, CDER, Division of Pharmaceutical Analysis, Silver Spring, MD, 2. FDA, CDER, Office of New Drug Quality Assessment, Silver spring, MD, 3.Takeda Global Research & Development Center, Inc., Deerfield, IL
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| Process Optimization Using Discrete Element Modeling |
| Atul Dubey, Rutgers, Piscataway, NJ
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| The Evolution of Modeling Techniques over the Lifecycle of a Product |
| Chris McCready, Umetrics
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| What is Feasible Today? Applied Modelling Approaches to Improving Quality Performance in Design and Operation for Solid Dose Form Products |
| Sander van den Bann, GSK
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| Application of R&D Development Models to Commercial Scale Performance: if needed Use of Monte Carlo Simulation for Both Process Mean and Variability to Predict Commercial Performance |
| Jean-Marie Geoffroy, Ph.D., Senior Fellow, Takeda Global Research & Development Centre, Inc., Deerfield, IL
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Screening & Surveillance/Handheld Instrumentation
Chair(s): Paul Vahey and John Kauffman
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| Detection of Illicit Drugs in Impaired Driver Saliva by Handheld SERS |
| Chetan Shende, Frank Inscore, Atanu Sengupta, Hermes Huang and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown, CT
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| Evaluating the Sensitivity of Library-Based Spectral Correlation Methods and Their Transferability Between Different Spectrometers |
| Jason D. Rodriguez, Lucinda F. Buhse, Benjamin J. Westenberger and John F. Kauffman, Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, St. Louis, MO
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| Handheld Infrared Spectroscopy: Practical Considerations for Instrument Design and Applications Development |
| John Seelenbinder, Agilent Technologies, Danbury, CT
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| Non-contact Molecular Surface Analysis using Hand-held, Widely Tunable Midinfrared Quantum Cascade Laser (QCL) Spectrometers |
| Jeffrey W. Sherman, Ph.D.; Frederick G. Haibach, Ph.D. and Erik Deutsch, Ph.D.; Block Engineering, LLC, Marlborough, MA
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| Miniaturized MID-IR Spectrometer for Online Oil Condition Monitoring in Offshore Windturbines |
| Benjamin Wiesent, TU München, Bavaria, Germany
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| Portable GC/MS (TBC) |
| Teresa Kristoff, Inficon, East Syracuse, NY
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| A New Miniaturized Fully Integrated NIR Spectral Engine for Handheld and Embedded Applications |
| John Coates, Coates Consulting
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Particle Characterization/Analysis/Ultrasound Spectroscopy
Chair(s): Jack Ragheb and Nuno Matos
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| Comparison of Different Techniques for Determination of Particle Size Distributions of Pharmaceutical Granules: Sieve Analysis, Laser Diffraction, Optical Microscopy and Spatial Filter Velocimetry |
| Vera Lourenco (a), Thorsten Herdling (b), Dirk Lochmann (b), Gabriele Reich (c), José C. Menezes (a), Jens Schewitz (b), (a) Institute of Biotechnology and Bioengineering, IST, Technical University of Lisbon, Portugal, (b) Quality Operations, PAT - Laboratory, Merck Serono, Darmstadt, Germany, (c) Institute of Pharmacy and Molecular Biotechnology, University of Heidelberg, Germany
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| PAT Applications for Spray Drying Processes |
| João G. Henriques, Hovione PharmaScience Ltd., Loures, Portugal
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| Enhanced Resolution for More Accurate Inline Particle Measurements in Crystallization |
| Benjamin Smith, Mettler Toledo, Columbia, MD
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| X-ray Foreign Particle Detection in Pharmaceutical Products - Current State of the Art and Recent Advances |
| Dr. Heino Prinz, Wilco AG, Wohlen, Switzerland
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| Differentiating Granule Quality through Particle Characterization in Pharmaceutical Process Development |
| Justin Pritchard and Martin Warman, Vertex Pharmaceuticals, Cambridge, MA
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| SVP Sub Visible Particle Analysis using Microscopic Fluid imaging to the USP 788 |
| Thomas Canty, J.M.Canty Inc., Lockport, NY
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| Sub Visible Particle Analysis section of ASTM E55 |
| Thomas Canty, J .M.Canty Inc., Lockport, NY
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| Electrospray-Differential Mobility Analysis: A Gas Phase High Resolution Method for Characterizing Bionanoparticles |
| Suvajyoti Guha1,2, Michael J. Tarlov2, Michael R. Zachariah1,2, 1 Departments of Mechanical Engineering, Chemistry and Biochemistry, University of Maryland, College Park, MD, 2 National Institute of Standards and Technology, Gaithersburg, MD
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| Electrical and Photographic Measurements of Particles in a Microfluidic Coulter Counter |
| R. E. Cavicchi, M. J. Carrier, Dean C. Ripple, Bioprocess Measurements Group, National Institute of Standards and Technology, Gaithersburg
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Process Communications
Chair(s): Jeff Hirsch and Chris Heil
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| Using OPC UA as the Next Generation Communication Protocol for PAT Data Management |
| Kjell Francois*, Johan Vanhoutte*, Elger Oestreicher+, * Siemens NV, Industrial IT, Huizingen, Belgium, + Siemens AG, Process Automation, Karlsruhe, Germany
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| OPC Unified Architecture (UA) Analyzer Device Integration (ADI) and Applications to Process Analytical Systems |
| Michael Crowder, ABB Inc., Lewisburg, WV
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| Information Technology (IT) Systems as Common Platforms for PAT and QbD |
| John Higgins*, Eric Ahuja*, Joe Bernal**, Jerry Hill**, Louis, Obando*, Nathan Pixley*, Manoharan Ramasamy*, and Gert Thurau*, *Global Science, Technology, and Commercialization, **Merck Manufacturing Information Technology, Merck Manufacturing Division, Merck and Co., Inc., West Point, PA
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| Accelerated Integration of Analytical Instruments into a Standardized Software Platform |
| Michael A. Power, Symbion Systems, Inc., Tustin, CA
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Life Cycle Management and Analyzer Reliability
Chair(s): Gert Thurau and Stephen Jacobs
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| Building in Robustness: Development and Validation of an NIR Composite Potency Method from a Large, Diversified Standard Set |
| John V. Spirig, Bristol-Myers Squibb, New Brunswick, NJ
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| Applying Process Analytical Technology for End-point Detection of Pharmaceutical Blending by Combining Two Calibration-free Methods: Simultaneously Monitoring Specific Near-infrared Peak Intensity and Moving Block Standard Deviation |
| Wataru Momose, Astellas Pharma Inc., Shizuoka, Japan
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| Driving to the Future State - Remote Analyzer System Management |
| Matthew MacConnell, Air Products, Allentown, PA
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| Experiences with System Performance Reliability in Pharmaceutical PAT Implementations |
| Nathan C Pixley, Merck & Co., Inc., West Point, PA
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| The Key Factors Affecting Robustness of Spectroscopic Results in QA/QC and PAT Applications from Instrument Design and Calibration Model Development |
| Yan Wang, Bruker Optics Inc., Billerica, MA
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| Robustness & Reliability of a PAT Solution in Pharma Industry |
| Glenn Restivo, Siemens Inc., Spring House, PA
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| Fault Detection and Diagnosis in Aluminium Processing using PAT Tools |
| Nazatul Majid1, Wei Yu2*, Mark Taylor2, John Chen2, Brent Young2 and Nick Depree2 1Department of Industrial Computing, The National University of Malaysia, Malaysia, 2Chemical & Materials Engineering Department, The University of Auckland, New Zealand
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| A Regulatory Perspective on NIR Method Robustness |
| Yubing Tang, Review Chemist, FDA, CDER, OPS, ONDQA
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PAT for the Dairy Industry
Chair(s): Tristan Hunter, Fonterra Co-operative Group Ltd. and Colm O'Donnell, Ph.D., University College, UCD Institute of Food & Health
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| The Fonterra APC programme: a foundation for PAT |
| Richard Croy and Tristan Hunter, Advanced Process Control Manager, Fonterra Co-operative Group Ltd., Hamilton, New Zealand
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| On the Potential of Electrical Resistance Tomography for Monitoring Milk Processing |
| Mohadeseh Sharifi1, Wei Yu1*, Brent Young1 ,Tristan Hunter2, Steve Holroyd2 & David Wilson3, 1 Chemical and Materials Engineering, The University of Auckland, New Zealand, 2Fonterra, New Zealand, 3Electrical & Electronic Engineering, Auckland University of Technology, New Zealand
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| Revealing Variations in Milk used in Cheese Making by the Use of FTIR |
| Julie Lundtoft Johnsen, Arla Foods amba, Brabrand, Denmark
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| FTIR Technology for Routine Milk Screening |
| Steve Holroyd1, Per Waaben Hansen2, Marlene Ransborg Pedersen2, 1.Fonterra Research Centre, New Zealand, 2. Foss Analytical A/S, Denmark, 3Arla Foods GCO R&D, Denmark
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| The Role of PAT in Control of Spray Drying of Dairy Ingredients and Formulations |
| Donal O’Callaghan, Moorepark Food Research Centre, Teagasc, Cork, Ireland
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| Development of PAT Tools for Cheese Manufacture |
| Colm P. O'Donnell, Ph.D., School of Biosystems Engineering, University College Dublin, Ireland
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| NIR Spectroscopy as a PAT Tool for Dairy Processing: Application and Challenges |
| Dr. Colette Fagan, Ph.D., Department of Food and Nutritional Sciences, University of Reading, Reading, UK
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| Advanced Process Control of Milk Coagulation for Cheese Making |
| Dr. Fred Payne, Ph.D., Department of Biosystems and Agricultural Engineering, University of Kentucky
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QbD
Chair(s): Theodora Kourti, James Cheney and Sharmista Chatterjee
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| An Application of MVDA to a Cell Cultivation Process |
| Marianna Machin, Novartis AG, Basel, Switzerland
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| In Search of Drug Product Critical Quality Attributes - A Materials Science Approach to Design Space Definition |
| Paul A. Trusty, GlaxoSmithKline, Ware, UK
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| Multivariate Techniques as Part of a Corporate PAT Strategy |
| Anna Persson, Umetrics, San Jose, CA
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| Integration PAT Real-time Process Monitoring and Physicochemical Characterization for Determining the Nucleation and Growth Mechanisms during a Dynamic Pharmaceutical Co-precipitation Process: A Process QbD Case Study |
| Huiquan Wu* and Mansoor Khan, FDA CDER, Silver Spring, MD
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| An Integrated PAT Approach to Develop a Dynamic Process Design Space for a Model Pharmaceutical Co-precipitation Process at Laboratory Scale: A QbD Case Study |
| Huiquan Wu*, Maury White, and Mansoor Khan, FDA, CDER, Silver Spring, MD
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| Application of Multivariate Analysis Tools to the Development of Drug Substance and Drug Product Processes following Quality by Design Principles |
| Christian Airiau, Simeone Zomer and Patrick Rameas, GlaxoSmithKline, R&D, Product Development, Data Management and Analysis
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Process Analysis (Spectroscopy)
Chair(s): George Vickers and Nathan Pillsbury
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| Real-Time Hydrogen Specific Analyzers for Process Improvements and Energy Conservation in Refineries and Petrochemical Plants |
| Mark Daugherty, H2scan Corporation, Valencia, CA
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| CO Monitoring of Coal Silos Using an In-Situ TDL |
| Warren Dean, Siemens Industry, Inc., Bartlesville, OK
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| Next Generation Infrared Technologies to Improve Waste Anesthetic Gas Monitoring for Hospital Occupational Health Safety |
| Miles Weida, Daylight Solutions, Inc., San Diego, CA
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|
| Practical Applications of Compact High-Resolution 60 MHz Permanent Magnet NMR Systems for Reaction Monitoring and Online Process Control |
| John C. Edwards, Process NMR Associates, LLC, Danbury, Connecticut, Paul J. Giammatteo, Process NMR Associates, Danbury, Connecticut, and Mark Zell, Pfizer Global Research and Development, Groton, Connecticut
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| Predicting Tablet API Concentrations using Transmission Raman Spectroscopy on Powder Blend Calibration Samples |
| Darren Andrews, Cobalt Light Systems Ltd., Oxfordsire, UK
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| Automated Material Validation using MR |
| Kimberly L. Colson1, Joshua M. Hicks1, Christian Fischer2, and Mark Garvey2, Bruker BioSpin Corp., Billerica, MA, USA1 and Bruker BioSpin GmbH, Rheinstetten, Germany2
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| The Benefit of the Third Generation On-line MRS Analysers |
| Gregory Shahnovsky, Tal Cohen and Ronny McMurray, Modcon-Systems Ltd. Akko, Isreal
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Bridging the Quality Gap between Benchtop and Field Instruments
Chair(s): Paul DeRose
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| This session will discuss the present state of instruments using light-based, non-destructive, optical detection. Existing quality practices, calibration techniques and standards for more conventional instruments will be compared to those for less developed instruments, for instance, comparing benchtop and field instrument applications. Can conventional quality practices be applied to less mature instrumentation and methods, and, if so, how and to what extent? The answers to these and other related questions will be addressed. |
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| Migration From Benchtop to Field: The Future of UV/Vis/NIR Instrument Calibration and Method Validation |
| Jeffrey L. Taylor, PerkinElmer
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| Raman Instrument Qualification- Benchtop (TBA) |
| Aaron Urbas, NIST
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| Multivariate Calibration and Instrument Standardization of Several Raman Spectrometers Used for Pharmaceutical Surveillance |
| Connie M. Gryniewicz-Ruzicka*, Jason D. Rodriguez and John F. Kauffman FDA, Division of Pharmaceutical Analysis, St. Louis, MO
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| Optical Spectroscopy Outside the Laboratory |
| Luisa T.M. Profeta, MRIGlobal, Kansas City, MO
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| Qualification of the Aqualog® as a Fluorometer for Analysis of Colored Dissolved Organic Matter Compounds that Cause Toxic Disinfection By-Products |
| Adam M. Gilmore, Horiba Scientific
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| Fluorescence Standardization and Biohazard Detection Beyond the Benchtop |
| Paul C. DeRose, NIST
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| Calibration and Validation Standards to Facilitate Data Exchange Between Raman Spectrometers |
| Aaron Urbas and Steven Choquette, NIST, Gaithersburg, MD
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Posters
Chair(s): Jerry Clemons, Antonio Moreira and Walter Henslee
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| Comparison of Different Probe Arrangements for Inline NIR Measurements during Fluid Bed Granulation |
| Hendrik Schneider and Gabriele Reich, University of Heidelberg, IPMB, Department of Pharmaceutical Technology and Biopharmaceutics, Heidelberg, Germany
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| On-line Moisture Monitoring of the Fluidized Bed Granulation Process by using High-speed and Highly Sensitive Near Infrared Spectrometer |
| Koudai Murayama*, Makoto Komiyama*, Takuma Genkawa**,*** Daitaro Ishikawa**,Yukihiro Ozaki**, *Yokogawa Electric Corporation, Tokyo Japan, **Kwansei Gakuin University, ***University of Tsukuba
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| In Situ Real-time Monitoring of Bioprocesses Using Process Analytical Technology (PAT): A Review of Recent Reports |
| Vaso Vlachos, Mettler Toledo, Columbia, MD
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| Microscale Devices for Examining Temperature-Dependent Interactions for Gases and Liquids |
| P. H. Rogers*, K. D. Benkstein*, C. B. Montgomery*, M. J. Carrier*, Z. Shen**, H. O. Sintim** and S. Semancik*, * Biochemical Science Division, National Institute of Standards and Technology, ** Department of Chemistry and Biochemistry, University of Maryland
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|
| In-Process Analysis of Moisture in a Fluid Bed Dryer with Near-Infrared Spectroscopy |
| Robert Mattes, FOSS NIRSystems, Inc., Laurel, MD
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|
| Clustering of Crude Oils using Unsupervised Machine Learning Algorithms |
| Gilberto Magalhães Xavier, PETROBRAS, Rio de Janeiro, Brasil
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| Multivariate Chemometric Analysis of Heparin Samples Containing Impurities and Contaminants using Near Infrared Spectral data |
| Qingda Zang1, David A. Keire2, Lucinda F. Buhse2, Richard D. Wood3, Christine M. V. Moore4, Moheb Nasr4*, Ali Al-Hakim4, Michael L. Trehy2, and William J. Welsh1, 1 Department of Pharmacology, Robert Wood Johnson Medical School, University of Medicine & Dentistry of New Jersey, Piscataway, NJ, 2 Food and Drug Administration, CDER, Division of Pharmaceutical Analysis, St Louis, MO, 3 Snowdon, Inc., Monmouth Junction, NJ, 4 Food and Drug Administration, CDER, Office of New Drug Quality Assessment, Silver Spring, MD, * GlaxoSmithKline, Collegeville, PA
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| Effects of Process Parameters on Granule Properties and In-Line Near Infrared (NIR) Monitoring of the Continuous Wet Granulation Process |
| 1Maiju Järvinen, 3Maunu Toiviainen, 2Thomas Meyer, 2Alexander Boppert, 2Dominik Sander, 1Jarkko Ketolainen, 3Mikko Juuti, 1Kristiina Järvinen, 1School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, 2Gebrüder Lödige Maschinenbau GmbH, Paderborn, Germany, 3VTT Optical Instruments, VTT Technical Research Centre of Finland, Kuopio
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| Creating Multivariate Calibrations for Field Asymmetric Ion Mobility Spectrometry using Partial Least Squares Regression |
| Dylan Jones, Genzyme, Suffold, UK
|
|
| 10 Bacillus Anthracis Spores Detected in 15 minutes by SERS |
| Frank Inscore, Hermes Huang, and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown, CT
|
|
| Pharmaceutical Drug Synthesis and Process Monitoring by Raman Spectroscopy |
| Mike Donahue, Wayne Smith and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown, CT
|
|
| An Advanced Process Analyser Management System |
| Gregory Shahnovsky, Tal Cohen and Ronny McMurray, Modcon-Systems Ltd. Akko, Isreal
|
|
| A NIRS-based PAT Tool to Measure Radial and Axial Concentration Profiles in Flowing Powder Mixtures: First results and Modelling efforts |
| N. Abatzoglou(*), E. Castellanos-Gil and Ryan Gosselin, (*) Corresponding author Université de Sherbrooke, Department of Chemical & Biotechnological Engineering, Chair Pfizer, Sherbrooke (Quebec), Canada
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|
| NIR Solution for Bioprocess Monitoring |
| Dr. Sven Gross, Sartorius Stedim Biotech GmbH, Goettingen, Germany
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| Hyperspectral Sensors Meet In-line and 'At-Line' Needs |
| David Bannon, Headwall Photonics, Inc., Fitchburg, MA
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| Making Food Products Safer through Hyperspectral Imaging |
| David Bannon, Headwall Photonics, Inc., Fitchburg, MA
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| Capturing Precise Spectral Information During Pharmaceutical Production |
| David Bannon, Headwall Photonics, Inc., Fitchburg, MA
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| Pharmaceutical Manufacturing Efficiency |
| Mr. Gopalakrishnan V B. Pharm, MBA., Sri Krishna Enterprises, Tamilnadu, India
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| Computational Modeling of Stem Cell, Applied for Cancer Research and Treatment of Human Rare Diseases |
| Mrs Katya Marinova Simeonova, Institute of Mechanics, Bulgarian Academy of Sciences, Sofia, Bulgaria
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| An Automated Online Sampling Solution for Improving Cell Culture Productivity |
| William Miller, Flowamics, Madison WI
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|
| Student Poster - Direct Detection of Active Pharmaceutical Ingredients in Intact Tablets by Helium Plasma Ionization Mass Spectrometry |
| Jason Mahr,1 Zhihua Yang,2 Athula B. Attygalle2, 1Montville Township High School, Montville, NJ, 2Center for Mass Spectrometry, Department of Chemistry, Chemical Biology, and Biomedical Engineering, Stevens Institute of Technology, Hoboken, NJ, USA
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| Methodology for Targeting Transformational Production of Biotherapeutics Through Leveraging Broader Process Understanding: Application of the Aseptic Sampling System (AAS) and Online and At-Line Bioreactor Monitoring and Feedback Tools for Rapid Process Development |
| L. Graham, B. Downey, D. Newbold and R. Ray, Bend Research Inc., Bend, OR
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| Real-time particle characterisation during granulation and milling |
| Ian Jones, PJ Cullen, Innopharmalabs, Dublin, Ireland
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|