Plenary Session: IFPAC/QbD/PAT/ONSITE Advanced Manufacturing for Modern Day Challenges
Chair(s): Troy Francisco, Rick Friedman, Steve Hammond and Christine M. Moore
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| Welcome, Overview IFPAC-2013 |
| Troy Francisco, DuPont Company, Wilmington, DE, Rick Friedman, OMPT, OC, OMPQ, CDER, FDA, Silver Spring, MD, Steve Hammond, Pfizer, Morris Plains, NJ and Christine M. Moore, OPS, ONDQA, CDER, FDA, Silver Spring, MD
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| Delivering on the Promise of Innovation in Pharmaceutical Development and Manufacturing |
| Peter Mueller, CSO, Vertex Pharmaceuticals, Inc., Cambridge, MA
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| Innovation and Technology through Sustainability |
| Dawn Rittenhouse, Director, Sustainability for the DuPont Company, Wilmington, DE
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| Advanced Manufacturing Techniques Open the Door to New Control Strategies |
| Dr. David Tainsh, Chief Product Quality Officer, GSK
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| Waveguide-Enhanced Mid-Infrared Diagnostics: Toward Next-Generation Tools for Process Analysis |
| Boris Mizaikoff, University of Ulm, Institute of Analytical and Bioanalytical Chemistry, Ulm, Germany
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| Biofuels - Ethanol Process, Operational Efficiencies = Sustainability |
| Brian Kletscher, CEO, Highwater Ethanol
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| Radical Innovation in Sensor Technology: The Qualcomm Tricorder X PRIZE |
| Mark Winter, Qualcomm Tricorder X PRIZE, Playa Vista, CA
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| The Current Status and Future Perspective of Process Analytical Technology (PAT) in China: A China Instrument and Control Society's View |
| Yuan Hongfu, Xianfeng Zhu and Li Zhang, China Instrument and Control Society, Beijing, China
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Technical, Regulatory and Business Case for PAT Implementation -International Consortium for Innovation and Quality In Pharmaceutical Development (IQ)
Chair(s): Doug Both and George L. Reid
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| This year's session will focus on the drivers for PAT implementation and the resulting value they deliver in the Pharmaceutical and Bio-pharmaceutical Industry. Presentations demonstrate how companies approach development and implementation of PAT due to technically driven issues such as scale up, manufacturability and process control. Regulatory driven strategy emphasizes the impact of PAT implementation on the business. This session will explore (1) current applications, (2) the technical base to underwrite the regulatory filing strategy, (3) regulatory agency interactions, (4) the business advantages of early problem detection and continual improvement; (5) associated challenges, including technical, internal and regulatory, and strategies to overcome, (6) measured costs/benefits to implementation, including personnel time, money, and quality. |
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| Insight, Foresight, and Oversight - Using PAT for Continuous Manufacturing |
| Andrew Birkmire, GEA Process Engineering, Inc, Columbia, MD
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| Examining the Need for a Multi-faceted Approach to the Characterisation of Powder Properties for Pharmaceutical Manufacture |
| Tim Freeman, Freeman Technology, Tewkesbury, Gloucestershire, UK
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| PAT for API Precision Spray-Coating Monitoring and Control: Two Years of Experience in the Manufacturing Floor |
| Manoharan Ramasamy, Merck/MSD, West Point, PA
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| Implementation of PAT for Real Time Release Testing |
| Mark Smith, Pfizer
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| Innovative Mass Spectroscopy for Pharmaceutical Development |
| Mark LaPack, Eli Lilly, Indianapolis, IN
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| Road to Real-Time Release |
| Gary McGeorge, Bristol-Myers Squibb, Mark Smith, Pfizer
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| Realizing Quality Benefits from PAT and Automation |
| Heather Schwalje, Emerson Process Management, Westborough, MA
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| Application of PAT for Hazard Mitigation and Process Control of an H202 Mediated Reaction |
| Yong Xie, Amgen, Inc., Thousand Oaks, CA
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| Advanced Process Control of Crystallisation via Supersaturation Control |
| David Jones, Pfizer Inc., Kalamazoo, MI
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Advanced Instrument Concepts
Chair(s): Fred Baudais
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| Advances in measurement instrumentation can enable advances to occur in industry. The Advanced Instrumental Concepts session focuses on the next generation analyzer technology to further the understanding and drive the optimization of industrial processes. This session includes instrument developments and applications that use instrumentation in new ways to solve unique problems. |
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| Photoacoustic Spectroscopy for Chemical Sensing |
| Stephen D. Roberson, Ellen L. Holthoff and Paul M. Pellegrino, U.S. Army Research Laboratory, Adelphi, MD
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| Highlighting Two of Owlstone's Real-Time Detection Systems that Change the Way Business is Done in the Lab at the Loading Dock and on the Plant Floor |
| Steve Freshman, Owlstone Inc., Norwalk, CT
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| Developments in Miniaturized Mass Spectrometry towards a Universal Chemical Detector |
| Warren K. Mino, David Rafferty and James Wylde, 1st Detect Corp., Houston, TX
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| A New Process Raman Spectrometer with Free Space Optics |
| Stan Ayers, Mustard Tree Instruments, Durham, NC
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| Organizing an Inline FTIR Implementation Using ACES: Application, Communication, Environment, and Sampling |
| Wes Walker, Mettler Toledo
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| Rapid Identification of Overdose Drugs in Saliva by Surface-enhanced Raman Spectroscopy |
| Chetan Shende, Hermes, Huang, Stuart Farquharson, and Frank Inscore, Real-Time Analyzers, Inc., Middletown CT
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| Long-Term, Continuous Monitoring of Trihalomethane (THM) Drinking Water Disinfection By-Products Using the INFICON CMS5000 Monitoring System Equipped with a Gas Chromatograph (GC) and Purge and Trap Sampling System |
| Christopher Huston, INFICON, Inc., East Syracuse, NY
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| Positive Material Identification and Quantification of Elemental Compositions in Steels using a Handheld LIBS probe |
| Christopher B. Stipe1, David Funnell1, Gregg A. Lithgow2, Steven G. Buckley2, 1Mechanical Engineering Department, Seattle University, Seattle, WA, 2TSI Incorporated, Redmond, WA
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| Process Patent Protection: Protecting Intellectual Property via Ambient Stable Isotopes |
| John P. Jasper, Nature's Fingerprint(R) / MIT LLC, Niantic, CT USA, Martin Pavane, Cozen O'Connor, New York, NY, Dean Eyler, Gray Plant Mooty, Minneapolis, MN, Ila Sharma and Albert Lee, Chemir Analytical Services, St. Louis, MO
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QbD/PAT - I
Chair(s): Dora Kourti and Jim Cheney
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| The Strength of PAT: from Process Understanding to Process Control. 3 Cases Studies in the area of API-production: Reaction, Crystallization and Centrifuge Drying |
| De Smet Koen, Johnson & Johnson, Beerse, Belgium
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| Application of Quality by Design in API Process Development |
| Nirav Shah, Umetrics, Wilmington, MA
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| Kinetics-Based Control of Chemical Processes at the Pilot Plant Scale |
| Jeffrey Nye, Bristol-Myers Squibb, New Brunswick, NJ
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| Role of Risk Assessment |
| Celia Cruz, FDA, Silver Spring, MD
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| MVA as a Diagnostic Tool for Complex Troubleshooting of Pharmaceutical Processes |
| Saly Romero-Torres, Pfizer, Peapack, NJ
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| Powder Consistency Measurement in Wet-granulation Control |
| Omar L. Sprockel, Bristol-Myers Squibb, New Brunswick, NJ
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| Examples for use of PAT Models in the Categories of Low-, Medium- and High-Impact according to ICH IWG Points to Consider Document in QbD Projects |
| Gert Thurau, Merck & Co., Inc., West Point, PA
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| Advances in Process MS for Product Drying in the Pharmaceutical Industry - Learning Lessons and Applying QbD Concepts to Instrument Design |
| Graham L. Lewis, Todd Colin, Ph.D. and Peter J. Traynor, Thermo Fisher Scientific, Cheshire, UK
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| Non-Contact Mass Verification of Solids and Liquids during and after the Dosing Process by VisioAMV |
| Sven Borchert, Uhlmann VisioTec, Laupheim, Germany
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PAT Implementation for Drug Product Development and Manufacturing
Chair(s): Tim Stevens and Ruben Lozano
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| This year we will focus more on the end-use, implementation and what is needed in manufacturing to support PAT as part of the process. Topics will include; changes to manufacturing quality systems to accept in-process control as part of release, integration and automation challenges, and instrumentation examples that have been implemented in manufacturing. We are also looking for examples of how PAT software (SynTQ, SiPAT, etc...) have been used both in development and in manufacturing to integrate data acquisition, data archiving, instrument control, and process control. |
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| Inline Monitoring of Ribbon Density by NIR during Roller Compaction |
| Kevin Macias, Tim Stevens, Ryan McCann and Douglas Both, Bristol-Myers Squibb Co., New Brunswick, NJ
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| In-line Feed Frame Monitoring of Granules during Tablet Compression |
| Angela Yang Liu, Pfizer
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| Experiences with Global use of a PAT-IT Software for Process Control and Real-time Release Testing Applications |
| Gert Thurau, Merck & Co., Inc., West Point, PA
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| Optimization and Control Strategies with Process Software and In-Line Particle Size Measurements |
| D. O'Grady, T. Redman and B. Smith, Mettler Toledo, Columbia, MD
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| Implementation of Online HPLC in Pharmaceutical Pilot Plants as a PAT Tool for Process Monitoring |
| Zhihao Lin, Merck & Co., Inc., West Point, PA
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| From Chaos to Control: PAT Data Acquisition and Management |
| Daniel Wasser, Bristol-Myers Squibb, New Brunswick, NJ
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| Process Control Strategy: Using Traditional Techniques to Develop a Complex and Maintainable PAT System |
| Paul Brodbeck, Control Associates, Inc., Allendale, NJ
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| NIR Method Design and Development, Technical Transfer and Model Maintenance Considerations for a Solid Dosage Form |
| Claudia Corredor, Bristol-Myers Squibb, New Brunswick, NJ
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Chemical Imaging
Chair(s): Steve Hammond and Carl Anderson
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| Insights into Capsule Performance using X-ray Imaging |
| Steve Hammond, Sr. Director, Pfizer
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| Approximating Theoretical and Empirical Detection Limits of Active Pharmaceutical Ingredients in Low, Moderate and High-Interfering Matrices utilizing Macro Infrared Spectroscopy and Micro Infrared Spectroscopic Imaging |
| Adam Lanzarotta, FDA Forensic Chemistry Center, Cincinnati, OH
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| 3D Terahertz Imaging of Multi-Layer and Coated Tablets |
| Mark Sullivan, Edward King and Eiji Kato, Advantest America, Inc., Princeton, NJ
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| Real-time NIR Chemical Imaging - Theory and Applications |
| Jun Huang, Pfizer, Peapack, NJ
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| Coating Uniformity of Film-Coated Tablets using Hyperspectral Imaging Systems |
| Hiroaki Arai1,2, Benoit Igne2, Sameer Talwar2, Shikhar Mohan2, Moon S. Kim3, Stephen R. Delwiche3, Erin T. Laraway3, Carl A. Anderson2 and James K. Drennen III2, 1 Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd., 2 Duquesne Center for Pharmaceutical Technology, 3 Food Quality Laboratory, USDA Agricultural Research Service
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| API Cleaning Verification using NIR Chemical Imaging |
| PJ Cullen, Dublin Institute of Technology, Dublin, Ireland
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| Use of Chemical Imaging during Continuous Process Development |
| Justin Pritchard and Slobodan Sasic, Vertex Pharmaceuticals, Inc., Cambridge, MA
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| Determining Empirical Advantages of EMCCD for Raman Hyperspectral Imaging |
| Vincent Larat, Eunah Lee and Andrew Whitley, HORIBA Scientific, Edison, NJ
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NeSSI
Chair(s): Mel Koch and Tom Dudley
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| Over the past ten 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), Process Intensification, and Green Chemistry. One of the key developments that has enhanced advances in these areas is in the standardization of process sampling, as exemplified by NeSSITM (the New Sampling and Sensor Initiative). The Center for Process Analysis and Control 9CPAC) has provided oversight for this program. Continued developments of the NeSSITM 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. |
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| Introduction and Updates on NeSSI Developments |
| Mel Koch, University of Washington, APL, CPAC, Seattle, WA
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| Benefiting from Smarter Sample Conditioning Systems |
| Michael Hoffman, Siemens, Montgomery, TX
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| Sample Purity: The Effect of Sample System Lines and Dead Legs |
| Doug Nordstrom, Swagelok, Solon, OH
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| Evolving Applications that Demonstrate the Versatility of the NeSSI Platform |
| Mike Cost, Parker Hannifin, Huntsville, AL
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| Moving Beyond Gen II to Achieve the NeSSITM Vision in Our Lifetime |
| Marcus Trygstad and David Novak, Yokogawa Corporation of America, Sugar Land, TX
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| The Integration of NeSSI into Research Projects Involving PAT and Process Optimization |
| Brian Marquardt, University of Washington, APL, CPAC, Seattle, WA
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| Back to the Basics: NeSSI or Not NeSSI |
| John Crandall, President, Falcon Analytical, Mike Cost, Analytical Product Manager, Parker Intraflow and Brian Rohrback, Infometrix, Bothell, WA
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| Commercial NMR that can be NeSSI Compatible |
| Jeff Sherman, PicoSpin, Boulder, CO
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| Breakthrough in Multigas Analysis using Nano Silicon Technology |
| Joshua Whiting, 3degrees of Separation Analytical, Dayton, OH
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Food Quality, Safety & Analysis Symposium: Emerging Technologies with Focus on Traceability and Contamination
Chair(s): Carol Zrybko, Ph.D., Mondelez International, East Hanover, NJ
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| 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. |
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| The Use of LA-ICP-TOF-MS and Discriminant Function Analysis in the Identification of the Elemental Composition of Cumin Samples and the Determination of the Country of Origin |
| Erin Ehrlinger, Towson University, Towson, MD
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| Standardization of Non-Targeted Spectrometry Tools to Detect Economic Adulteration in Skim Milk Powder |
| Lucy L. Botros, U.S. Pharmacopeia Headquarters, Rockville, MD and Jeffrey C. Moore, Senior Scientific Liaison to the Food Chemicals Codex, U.S. Pharmacopeial Convention (USP)
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| Food Forensics with Combined Microscopy and Spectroscopy Methods |
| Jinping Dong, Var St.Jeor, Abigail Lape, Carrie Lendon, Serpil Metin, Erik Hagestuen, and William R. Aimutis, Global Food Research, Cargill, Navarre, MN
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| Rapid (<5 min) FT-NIR Screening of Edible Oils for the Determination of the Total SFA, Trans FA, MUFA and PUFA Contents and Comparison to GC and Declared Values on Nutrition Facts Panels |
| Magdi M. Mossoba1*, Hormoz Azizian2, Cynthia Tyburczy1, John K.G. Kramer3۞, Pierluigi Delmonte1, Ali-Reza Fardin Kia1, and Jeanne I. Rader1, 1Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Regulatory Science, Food and Drug Administration, College Park, MD, USA, 2NIR Technologies Inc., Oakville, ON, Canada, 3Guelph Food Research Center, Agri-food Canada, Guelph, ON, Canada ۞ Retired
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| Food Allergens - Analytical Challenges in Detecting Modified Proteins |
| Simon Flanagan, Mondelez International, Reading, UK
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| Mass Spectrometry Based Proteomics (MSP) Approach for Non-Restrictive Detection of Emerging Microbial Contaminants in Food Samples |
| Rabih E. Jabbour, U.S. Army Edgewood Chemical Biological Center, Aberdeen Proving Ground, MD, Samir V. Deshpande, Science and Technology Corporation, Edgewood, MD, Patrick McCubbin, Optimetrics Inc. Abingdon, MD, and Robert Webb, Public Health Command, Aberdeen Proving Ground, MD
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| Critical Attributes for On-Line and At-Line Process Instrumentation: Industry Examples of Successful Implementation in the Snacks Food, Cookie and Confectionary Coating Production Processes |
| Dr. Andrew Grady,NDC Infrared Engineering, Essex, UK
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| Assessing the Threat of Chemical Terrorism: Dissemination of Toxic Chemicals through Food |
| Janet Moser, Chemical Security Analysis Center, Department of Homeland Security, Gunpowder (APG), MD
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QbD/PAT - II
Chair(s): Sharmista Chatterjee, Theodora Kourti and James Cheney
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| Developing an Integrated Data Management and Multivariate Analysis Toolset for Scientists and Engineers |
| Mark Mordeca*, Mark-John Bruwer*, John F. MacGregor*, Andrew Skalkin~, Adam Fermier~, Steve Mehrman~, Walter Cedeno~, John Cunningham~, Victor Lobanov~, John Knighton~, Gene Schaefer~: * ProSensus Inc., ~ Janssen Pharmaceutical R&D, Johnson & Johnson, * * Ancaster, ~ Spring House, * ON, ~ PA * * Canada, ~ USA
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| PAT and First-Principle to Pharmaceutical Crystallization Process Development: A FDA Scientist's Perspective |
| Huiquan Wu, Huiquan Wu, Maury White, and Mansoor Khan, 1Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research (OTR), Office of Pharmaceutical Sciences (OPS), Center for Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA)Silver Spring, MD
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| The Use of PAT as part of a Mechanistic Approach to API QbD Process Development and Control Strategy |
| Robert Yule, Project Team Leader, PGCE, PTS Product Development, Research Triangle Park, NC
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| Using PAT and Process Data More Effectively: Process Analysis, Understanding and Control |
| Pedro Felizardo, Tiago Robalo, M. Joana Mendes, Joao E. Machado, 4TUNE Engineering ltd., Lisbon, Portugal
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| Predictive Multivariate SPC Monitoring of Batch Processes |
| Chris McCready, Umetrics, London, Ontario, Canada
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| MSPC for Spray Drying Processes as a Tool for Real Time Monitoring and Control and Enabler of Real Time Release Testing (RTRT) |
| Joao G. Henriques (1), Tiago Robalo (2), Pedro Felizardo (2), Hovione (1); 4TUNE Engineering Ltd (2),Lisbon, Portugal, Sete Casas (1), Loures, Portugal
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| ADI Connect and ADI Insight: Platform Independent Communication Protocol allowing Seamless Integration between Devices, Control Systems and Multivariate (chemometric) Models for Practical QbD Implementation |
| Brad Swarbrick, Vice President Business Development, CAMO Software AS, Oslo, Norway and Mark L. Zugelder: Customer Segment Technology Manager, ABB, Burlington ON, Canada
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| An Integrated PAT Enabled Solution for Pharmaceutical Hot-melt Extrusion Process |
| (TBA) - Brabender / Juergen Manz - Siemens, Karlsruhe, Germany
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| QbD for Aseptic Processes: A Microbiological Proposal |
| Gilberto Dalmaso, Particle Measuring Systems, Roma, Italy
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BioTech - II - PAT Applied for Biologics Manufacturing
Chair(s): Jose C. Menezes and Ranjit R. Deshmukh
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| Inline Monitoring to Improve Purification of Biological Systems |
| Benjamin Smith and Vaso Vlachos, METTLER TOLEDO, Columbia, MD
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| Application of PAT Tools for Efficient Bioprocess Automation and Optimization |
| Andree Ellert, Sartorius Stedim Biotech GmbH, Goettingen, Germany
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| Automated Control of Feeding in Upstream Bioprocesses via a Miniature, In- Situ, Solid State Optical Sensor |
| Greg Emmerson, Sam Watts, and George Barringer, Stratophase Ltd, Romsey, UK
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| Probing the Bioreactor with Capacitance and Dielectric Scanning for Biomass, Viability, and Morphology |
| Jeff Breit, Ph.D., Bend Research Inc.
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| Advanced Real-time Monitoring of Cell Growth in Therapeutic Protein Production using Dielectric Spectroscopy and Chemometrics |
| Hae Woo Lee and Seongkyu Yoon, Univ. of Massachusetts, Lowell, MA
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| Assessment of Complex Raw Materials Variability and their impact on Mab Fermentations: Detecting Aging of Media Components |
| Christian Hakemeyer*, Ulrike Strauss, Silke Werz - Roche Diagnostics GmbH - Pharmaceutical Biotech Production & Development, Penzberg, Germany, Francisca Folque, Pedro Felizardo - 4TUNE Engineering Ltd, Lisbon, Portugal, Jose C. Menezes - Institute for Biotechnology and Bioengineering, Technical University of Lisbon,Lisbon, Portugal
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| Use of Raman Spectroscopy to Monitor Fermentation & Key Constituents in Small & Large Molecule Fermentations |
| Saly Romero-Torres, Pfizer, Peapack, NJ
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| On-Line Multivariate Analysis (MVDA): A Platform PAT Tool for Vaccines and Biologics |
| Charles E. Miller, Louis Obando, John Higgins, Gert Thurau and Eric Ahuja, Merck, West Point, PA
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| Near-Infrared and Raman Spectroscopy for In-Line Monitoring of Protein Unfolding and Its Interactions with Lyoprotectants during Freeze-Drying |
| Thomas De Beer1, Sigrid Pieters , Laurent Hansen1, Julia Kasper , Wolfgang Friess , Yvan Vander Heyden , 1Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ghent, Belgium, Department of Analytical Chemistry and Pharmaceutical Technology, Center for Pharmaceutical Research, Free University of Brussels (VUB), Brussels, Belgium, Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians University, Munich, Germany
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PAT Approaches for Continuous Manufacturing
Chair(s): Eric Jayjock and 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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| Progress in Implementing Continuous Processing during Drug Development |
| Patricia Hurter, Senior VP, Global Pharmaceutical Development, Vertex Pharmaceuticals, Inc., Cambridge, MA
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| Powder Feeder Pairing with Downstream Continuous Mixer |
| William Engisch, Rutgers University, Piscataway, NJ
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| Hot Melt Extrusion PAT |
| Manoharan Ramasamy, Merck, West Point, PA
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| Flowsheet Modeling Methods for Design and Optimization of Continuous Powder Processes |
| Fani Boukouvala (speaker), Ravendra Singh, Eric Jayjock, Marianthi Ierapetritou, Fernando Muzzio and Rohit Ramachandran, ERC-SOPS, Rutgers University, Piscataway, NJ
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| Optimal Operation and Advanced Control of a Flexible Multipurpose Continuous Pharmaceutical Tablet Manufacturing Process |
| Ravendra Singh, Fani Boukouvala, Eric Jayjock, Marianthi Ierapetritou, Fernando Muzzio and Rohit Ramachandran, Engineering Research Center for Structured Organic Particulate Systems (ERC-SOPS), Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ
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| Improved Flowability and Packing Density of API Powders via Dry Coating for Continuous Manufacturing of Direct Compressed Tablets |
| Rajesh Dave and James Scicolone, NJIT
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| Continuous Powder Blending with In-line NIR as a PAT Tool |
| Juan G. Osorio, Rutgers University, Department of Chemical and Biochemical Engineering, Piscataway, NJ
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| Automating Verification of On-line Total Organic Carbon (TOC) Analysis of CIP Final Rinse Processes |
| Ronan Hayes and Donnacha Collins, Janssen Biologics, Cork, Ireland, Chris Crone and Paul Farrell, Hach Company, Grants Pass, OR
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| Building a Direct Compression Continuous Line - A Case Study |
| Eric Jayjock and Fernando Muzzio, ERC-SOPS, Rutgers University, Piscataway, NJ
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Chemometrics (COPA) - I
Chair(s): Karen Bloch and Brian Rohrbach
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| Chemometrics has been around as a field since the early 1970s and came into routine use in the early 1990s. There is still a gap, however, between the level of effort that has been aimed at R&D and what has been implemented for process applications. To help close this gap, CPAC formed an initiative called COPA (Chemometrics for On-line Process Analytics) which relies on the IFPAC meeting as a means of communicating new approaches to use of multivariate methods for on-line and near-line quality assessments and process control. The session raises issues and combines input from analytical instrument manufacturers, software purveyors, academia and end-use industry to stimulate discussion of the field and how to best take advantage of chemometrics technology in a profitable way. |
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| Run Design! Initial Steps The Dow Chemical Company is taking to conquer Big Data in Manufacturing |
| Lloyd F. Colegrove, Mary Beth Seasholtz and Bryant LaFreniere, The Dow Chemical Company, Freeport, Texas and Louis Halvorsen and Dave Shearer, Northwest Analytics, Portland, Oregon
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| Multivariate Analysis of Metabolomic Data in Fermentation Process Development |
| D. Christopher Roe, DuPont CR&D, Corporate Center for Analytical Sciences, Wilmington, DE
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| Methods for Data Handling in Two-dimensional Chromatography: are current algorithms correct? |
| Gabriel Vivo Truyols, University of Amsterdam, Amsterdam, Noord Holland, The Netherlands (Double time slot)
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| Enhanced Classification Using Fused Data |
| Bob Roginski, Eigenvector Research, Michael Dotlich, Eli Lilly & Co., and Jeremy Shaver, Eigenvector Research
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| The Process Understanding Tool: Two-dimensional Correlation Spectropscopy and its Applications |
| Yan Wang, Bruker Optics Inc., Billerica, MA
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| The COPA Initiative: Retro-and Pro-spective |
| Brian G. Rohrback, Infometrix, Inc., Bothell, WA
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| A New Approach for Understanding the Ethanol Precipitation Process of Chondrointin Sulfate using Multivariate Analysis |
| Zang Hengchanga , Li Liana, Wang Jinfenga, Jiang Weia, Ding Baoyanga, Yang Qia, Chen Shanga, a National Glycoengineering Research Center and School of Pharmaceutical Science, Shandong University, Jinan,China
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Food Quality, Safety & Analysis Symposium: PAT for the Dairy Industry
Chair(s): Tristan Hunter, Fonterra Co-operative Group Ltd., New Zealand and Colm O'Donnell, Ph.D., University College, UCD-Dublin Institute of Food & Health, Dublin, Ireland
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| 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. |
| This session content now contains a broader range of content covering industrial food processing (not just Dairy).
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| Advanced Process Control of the Enzymatic Coagulation of Milk for Cheese Making |
| Fred Payne, University of Kentucky, Lexington, KY
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| NIR as a PAT Tool for Dairy Processing: Applications and Challenges |
| Colette Catherine Fagan, University of Reading, UK
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| Milk Powder Process Optimization with FT-NIR |
| Florian Eigenmann, Bruker Optics Inc, The Woodlands, Houston TX (USA) and Andre Kok, Bruker Optik GmbH, Ettlingen, Germany
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| Intelligent PAT-based Control and Optimization System for Nutrition Manufacturing |
| Jun Huang, Pfizer, Peapack, NJ
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| Setting Simultaneous Specifications on Multiple Raw materials to Ensure Product Quality and Minimize Risk |
| John MacGregor, Zheng Lu, Mark-John Bruwer, ProSensus, Inc. and Boris Polsky and Glenn Visscher, Mondelez International
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| Building a Real-Time Quality Programme for Dairy |
| Tristan Hunter, Ph.D. and Nigel Russell, Fonterra Co-operative Group Ltd., New Zealand, David Wilson and Nick Depree, Auckland University of Technology, Taj Munir and Brent Young, The University of Auckland
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| Application of Ultrasound Spectroscopy for In-situ Monitoring of Dairy Processes |
| R. J. Tweedie1, W. Jablonska1 and J. K. Amamcharla2, Industrial Tomography Systems plc, Manchester, UK1, Animal Sciences and Industry Department, Kansas State University, Manhattan, KS
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| Panel Discussion |
| Part 1: Discussion topic - Opportunities and challenges implementing a PAT programme for food processing Four speakers across commercial and academic sectors will each share their perspective, with time allowed for comments & questions from the floor Part 2: Audience feedback Attendees have opportunity to indicate whether they see value, and would be interested in participating in an online forum 'Applied PAT in industrial food processing'.
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Continuous Manufacturing
Chair(s): Vibhakar Shah and Theodora Kourti
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| PAT Applied to Continuous Pharmaceutical Manufacturing - Taking the Next Step |
| Lorenz Liesum, Novartis, Basel, Switzerland
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| Continuous Processing and 100% Inspection in Pharmaceutical Processes |
| Florian Staeudle, Uhlmann VisioTEC GmbH, Laupheim, Germany
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| Moving towards Continuous Manufacturing: Successful Real -Time Monitoring, Early Detection and Process Control |
| Nirav Shah, Umetrics, Wilmington, MA
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| In-depth Analysis of Multiple Logged Process Parameters during a Continuous Granulation and Drying Process |
| Jurgen Vercruysse1, Margot Fonteyne2, U. Delaet3, I. Van Assche3, Jean Paul Remon1, Chris Vervaet1, Thomas De Beer2, 1Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, 2Laboratory of Pharmaceutical Process Analytical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, 3Department of Pharmaceutical Development, Johnson&Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Beerse, Belgium
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| In-line Monitoring and Control Systems Designed to Ensure the On-demand Supply of Pharmaceutical Tablet Coating Solutions Prepared by an Automated Process Unit |
| Sophie Belley, University of Sherbrooke, Sherbrooke, Quebec, Canada
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| Process Rheology in Polyolefins Manufacturing |
| Birgit Braun, Marc Dees, Rinus Nieuwenhuize and Brenda Colegrove, The Dow Chemical Company, Freeport, TX
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| Implementation of PAT in Conjunction to Predictive Filter Function Models to Measure Product Quality and Integrate Product Tracking on a Continuous Tabletting Line |
| John Palmer, Newcastle University, Centre Merz Court, Biopharmaceutical and Bioprocessing Technology, Newcastle Upon Tyne, UK
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Bio Processing and Biosensing- (Industrial)
Chair(s): Jim Cronin and Ron Hoffman
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| NIR-Spectroscopy for Bioprocess Monitoring & Control |
| Dr. Sven Gross, Sartorius Stedim Biotech GmbH, Goettingen, Germany
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| Online Glucose-Lactate Monitoring and Control in Cell Culture and Microbial Fermentation Bioprocesses |
| Henry Weichert *, Mario Becker, Sartorius Stedim Biotech GmbH, Goettingen, Germany
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| Using a Novel Dielectric Spectroscopy Methodology to Monitor Cell State |
| Brandon Downey, Bend Research Inc.
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| Insights into Monitoring Changes in the Viable Cell Density and Cell Physiology using Scanning, Multi-frequency Dielectric Spectroscopy |
| John Carvell, Aber Instruments Ltd., Ceredigion, UK
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| Monitoring Biofuel Production: From Lab to Plant |
| Wayne Smith, Michael Patient, and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown CT
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| A New Integrated Capability for Detection, Collection and Identification of Bio-Aerosols |
| Kenneth J Klein, Smiths Detection, Inc., Edgewood, MD
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| Small Optical Sensors for Oxygen Monitoring in Process Environments |
| Charles W. Branham, Mark Weller, Kent Mann and Brian Marquardt, University of Washington, University of Minnesota, Charles Branham, Applied Physics Laboratory, University of Washington, Seattle, WA
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| Microbiological Mycoplasma Assay with PCR |
| Esther Presente, Amgen, West Greenwich, RI
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Screening & Surveillance/Handheld Instrumentation
Chair(s): John Kauffman and Paul Vahey
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| The Portable Hand-Held Analyzer session will generate discussion on how hand-held technologies fit into the big picture: who needs them, when to use them vs. less-portable options, and how they're deployed & supported. Portable analyzers are expanding analytical possibilities beyond the lab forcing us to re-think how we will deploy and support analyzers, collect & manage data, and generate a robust system to make decisions based on the information gained. How will we manage the new analytical labs that we used to call Shipping & Receiving, Customs, and The Factory Floor ? What is unique to handheld and portable instruments vs. traditional benchtop devices in terms of their infrastructure requirements (training & administrators), maintenance, value in the decision pathway, presentation of results, and archiving of data? |
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| Palm-size Near Infrared Spectrometer for Pharmaceutical Applications |
| Nada A. Obrien, JDS Uniphase Corporation, Santa Rosa, CA
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| Screening and Identifying Pharmaceutical Counterfeits |
| Ravi Kalyanaraman, Bristol-Myers Squibb, New Brunswick, NJ
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| Military Grade Hand-held Raman Spectrometer |
| Carl Brouillette, Stuart Farquharson, and Wayne Smith, Real-Time Analyzers, Inc., Middletown CT
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| Enhancing the Safety of the Pharmaceutical Materials Supply Chain through Field-Deployable Spectral Libraries |
| Jason D. Rodriguez, Allison L. Saettele, Katherine, A. Berry, Derya Cebeci Malta, John F. Kauffman, and Lucinda F. Buhse, U.S. Food and Drug Administration/Division of Pharmaceutical Analysis, St. Louis, MO
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| Rapid Screening of Pharmaceutical Products and Dietary Supplements by Portable Ion Mobility Spectrometers |
| Connie Gryniewicz-Ruzicka, US Food and Drug Administration, St. Louis, MO
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| Implementation of Portable Raman through the Pharmaceutical Supply Chain |
| Jeffry W. Denault, Eli Lilly, Indianapolis, IN
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| Handheld Spectrometers - Field Applications from Raw Material Confirmation to Counterfeit Detection and Illicit Narcotics Identification |
| Suzanne Schreyer, Thermo Fisher Scientific, Tewksbury, MA
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Chemometrics (COPA) - II
Chair(s): Brian Rohrbach and Karen Bloch
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| Advances in Process Data Analysis |
| Juergen von Frese, Data Analysis Solutions DA-SOL GmbH, Utting, Germany
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| PAT and Smart Chemometrics in Rapdid Prototyping and Scale Up |
| Ornella Preisner1,2, Jerry Cooper2 and Julian Morris1, 1Centre for Process Analytics and Control Technology, School of Chemical Engineering and Advanced Materials, Newcastle University, UK, 2Centre for Process Innovation, Wilton, Teesside, UK
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| Understanding Raw Material Variation in Roll Compaction through Orthogonal Projections to Latent Structures and Experimental Design Based Process Modeling |
| Nabil Souihi, Melanie Dumarey, Hakan Wikstroem, Pirjo Tajarobi, Magnus Fransson, Olof Svensson, Mats Josefson and Johan Trygg, Computational Life Science Cluster (CLiC), Department of Chemistry, Umea University, Sweden, Pharmaceutical Development, AstraZeneca R&D Moelndal, Sweden
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| Input Variable Selection based on the Correlation-based Variable Clustering |
| Koichi Fujiwara, Kyoto University, Kyoto, Japan
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| Application of Data Fusion for Enhanced Process Understanding and Control |
| Thomas I. Dearing 1., Rachel Mohler 2., Michael F. Roberto 1., Carl Rechsteiner Jr. , 2. and Brian J. Marquardt 1.*, 1. Applied Physics Laboratory, University of Washington, Seattle, WA, 2. Chevron Energy Technology Company, Richmond, CA
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| OPLS and O2PLS for Improved Interpretation of Multivariate Calibration Models |
| Jakob Christensen, Umetrics, Sweden
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| Chemometrics in the 21st Century |
| Barry K. Lavine, Department of Chemistry, Oklahoma State University, Stillwater, OK (Double time slot)
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Food Quality, Safety & Analysis Symposium: Food Safety
Chair(s): Luis E. Rodriguez-Saona, Ph.D., The Ohio State University, Columbus, OH and Jayne Morrow, Ph.D., NIST, Gaithersburg, MD
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| 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 |
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| Detection of Pathogens in Food using a SERS-based Assay |
| Atanu Sengupta, Chetan Shende, Stuart Farquharson and Frank Iscore, Real-Time Analyzers, Inc., Middletown CT
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| Classification of Bacterial Colonies by Hyperspectral Imaging |
| Stephen P. Walker, University of Kentucky, Dept of Biosystems and Agricultural Engineering, 128 C.E. Barnhart Building, Lexington, KY
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| Integration of Genomics and Proteomics for Food Safety |
| Marc W. Allard 1, Melinda McFarland 1, Denis Andrzejewski 1, Robert Stones 2 1 Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, College Park, Maryland and 2 Food & Environment Research Agency
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| Single Nucleotide Polymorphism Validation for Food-borne Pathogen Strain Level Identification |
| Nathan Olson, Steven Lund, and Jayne Morrow, NIST, Gaithersburg, MD
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| Rapid Identification of Microbial Contaminants in Bulk Commodities and Food Storage Environments |
| Andrew P. Bartko, Battelle Memorial Institute, Columbus, OH
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| The USP Spectral Library Project |
| Bei Ma, U.S. Pharmacopeial Convention
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| Food Analysis & Safety Chemical Detection (TBC) |
| (TBA), FDA, CFSAN, College Park, MD
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Life Cycle Management of System and Analyzer Reliability - 2013 Theme: PAT Method Robustness
Chair(s): Gert Thurau and Martin Warman
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| This session will host papers on robustness and reliability of Process Analytical implementations. Presenters will discuss aspects of hardware, methods and maintenance that improve the performance of systems over the life cycle of the implementation. |
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| A Critical Discussion of EMA's NIR Draft Guideline on the use of NIRS by the Pharmaceutical Industry |
| Jose C. Menezes, Technical University of Lisbon, Lisbon, Portugal
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| Material Properties and How They Impact Quantitative NIR Method Robustness |
| Gary McGeorge and Dongsheng Bu, BMS
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| Ensure Long Term Method Robustness via Life Cycle Management |
| Yang Angela Liu, Pfizer, Groton, CT
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| Multivariate Outlier Diagnostics - And Their Role in PAT Robustness and Quality |
| Charles E. Miller, Nathan Pixley, Bruce Thompson, John Higgins, Manoharan Ramasamy and Gert Thurau, Merck, West Point, PA
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| Process Model Implementation and Maintenance - Lessons Learned |
| Thomas Gandek, Ph.D., Vice President Technical Operations, Vertex Pharmaceuticals, Inc., Cambridge, MA
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| Data Quality Reliability and Analyzer Oversight |
| Paul Coram, Kris McGarvey, Eric Engelen, Aaron Eidt and Jeff Mason, Dow Chemical Company
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| Robustness Features of Multichannel NIR Analysers based on Diode Array Technology |
| Uwe Kirschner and Sebastian Sowinski, Sentronic GmbH, Dresden, Germany
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| The Development of Analytical Methods for Cleaning Validation and Continued Verification: A Life-cycle Approach |
| Kevin Aumiller, Hyde Engineering + Consulting, Boulder, CO
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Process Analysis (Spectroscopy/Sensors/Probes/Optics) - II
Chair(s): Nathan Pillsbury and George Vickers
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| A New Approach for Understanding the Ethanol Precipitation Process of Chondrointin Sulfate using Multivariate Analysis |
| Zang Hengchang, Shandong University, Jinan,China
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| On-Line Determination of the Molar Ratio Between Methanol and Isobutylene in Feedstock of a Methyl Tertiary Butyl Ether Production Unit Using Short Wavelength Near-Infrared Spectroscopy |
| Hongfu Yuan 1,Xianhui Luo 2,Xiaoli Chu 3, 1 Beijing University of Chemical Technology, Beijing, China, 2 Synthesis Rubber Plant of Beijing Yansan Petrochemical Co. Ltd., Beijing, China3 Research Institute of Petroleum Processing, SINOPEC, Beijing, China
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| On-line Spectroscopy Combined with Second-order Calibration Based on Alternating Trilinear Decomposition as a Novel Process Analytical Technology |
| Hai-Long WU*, State Key Laboratory of Chemo/Biosensing and Chemometrics, College of Chemistry and Chemical Engineering, Hunan University, Changsha, China
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| Enhanced Calibration Model Transferability using Net Analyte Signal Based Multivariate Regression |
| Robert W. Bondi, Jr., Benoit Igne, Carl A. Anderson and James K. Drennen, III, Duquesne Center for Pharmaceutical Technology
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| High-Resolution NMR Methods for Metabolomics Studies |
| D. Christopher Roe, DuPont CR&D, Corporate Center for Analytical Sciences, Wilmington, DE
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| Applications of Plasma Techniques in Process Analytical Chemistry |
| Yixiang Duan, Research Center of Analytical Instrumentation, Analytical & Testing Center, College of Chemistry, Sichuan University, Chengdu, China
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| Quantitative Measurement of Crystalline/Amorphous Content in Solids using Terahertz Pulsed Spectroscopy |
| Mark Sullivan, Advantest America, Inc., Princeton, NJ
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| CO Measurement for Safety in ESP's using TDL |
| Warren Dean, Siemens Industry, Inc., Bartlesville, OK
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Process Analysis
Chair(s): Walter Henslee
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| The Effect of Ambient Humidity on the In-process Behaviour of Powders |
| Tim Freeman, Freeman Technology Ltd, Gloucestershire, UK
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| MR Spectroscopy for Quality Control Testing of Heparin, using the Assure-RMS Software |
| Michelle Markus, Bruker BioSpin, Billerica, MA
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| Applying NIR to High Shear Wet Granulation - Just another Possibility or State of the Art PAT Tool? |
| Uwe Kirschner, Managing Director Sentronic GmbH, Germany, Sebastian Sowinski, Key Account Manager Sentronic GmbH, Germany, Phil Doherty, Managing Director, Process Analytics Ltd., Ireland, Sentronic GmbH, Dresden, Germany
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| Vibrating Technology in Fluids Characterization |
| Corentin Thierry, Sofraser, Villemandeur, France
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| Surface Plasmon Resonance Imaging: A Potential Label-free High throughput Process Analytical Method |
| Yi Chen, Key Laboratory of Analytical Chemistry for Living Biosystems, Institute of Chemistry, Chinese Academy of Sciences, Beijing, China
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| Integrated Data Management for Manufacturing Processes and QA Labs to Support RTRt |
| Masanobu Sudo, Kiyoshi Minamiura, Yokogawa Electric Corporation, Tokyo, Japan
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| Development of an Automated Modular Permeation System for Creating Complex Calibration Gas Mixtures |
| Danet Vrazel, KIN-TEK Laboratories Inc., La Marque, TX
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| Process FTIR Technology for Supporting Quality by Design (QbD) of a Pharmaceutical Reaction Process |
| Zhihao Lin, Merck & Co., Inc., Rahway, NJ
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Food Quality, Safety & Analysis Symposium: PAT as a Quality Control Tool
Chair(s): Patrick J. Cullen, Ph.D., Dublin Institute of Technology, School of Food Science and Environmental Health, Dublin, Ireland
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| This session will include discussions on process analytical technologies capable of providing quality control during food manufacturing. The business merits and strategies of PAT adoption will be discussed. The potential of PAT to support food regulation strategies will be addressed. |
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| Continuous Process Monitoring and Control in the Food Industry by Near-Infrared Spectroscopy |
| Chris Heil, Thermo Fisher Scientific, Madison, WI
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| Continuous Analysis of Powder Infant Formula |
| Patrick J. Cullen, Ph.D., Dublin Institute of Technology, School of Food Science and Environmental Health, Dublin, Ireland
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| Assessing Control Performance within a PAT Framework |
| Nick Depree and Prof. Brent Young, University of Auckland, Auckland, New Zealand
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| A Proven Approach to Success: The Strategy Behind How US FDA Mobile Food Testing Laboratories were Developed and Why Twelve Years Later They are Still Key to the Protection of Our Nation's Food Supply |
| Monica Heyl & Associates, LLC
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| Food Safety Modernization Act: Open Panel Discussion |
| Carol Zrybko, Ph.D., Mondelez International, East Hanover, NJ, Luis E. Rodriguez-Saona, Ph.D., The Ohio State University, Columbus, OH, Jayne Morrow, Ph.D., NIST, Gaithersburg, MD, Tristan Hunter, Ph.D., Fonterra Co-operative Group Ltd., New Zealand, Colm O'Donnell, Ph.D., University College, UCD-Dublin Institute of Food & Health, Dublin, Ireland and Patrick J. Cullen, Ph.D., Dublin Institute of Technology, School of Food Science and Environmental Health, Dublin, Ireland
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Posters
Chair(s): Antonio Moreira, Jerry Clemons and Walter Henslee
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| Detecting Toxic Industrial Chemicals Using a Handheld Differential Mobility Spectrometer (DMS) |
| Paul J. Rauch, Chemring Detection Systems, Charlotte, NC
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| Advanced Applications of Raman Micro-Spectroscopic Mapping for Evaluation of API States and Unknown Component in Pharmaceuticals |
| Takahiro Ozawa, Eisai Co., Ltd., Gifu, Japan
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| Facilitating Multisite BioProcess Transfer: Multi-Instrument and Multi-Platform Comparability and Long Term Stability of Nova Biomedical's BioProfile(R) Chemistry and Gas Analyzers |
| Matt McRae, Nova Biomedical, Waltham, MA
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| IgG Quantification and Correlation in Cell Culture Media with the BioProfile(R) FLEX Automated Cell Culture Analyzer |
| Brian Goulart, Nova Biomedical, Waltham, MA
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| On-line Monitoring and Control of Moisture in the Fluidized Bed Granulator by High-speed and Highly Sensitive Near Infrared Spectrometer |
| Koudai Murayama and Makoto Komiyama, Yokogawa Electric Corporation, Tokyo, Japan
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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 AutoChem, Inc., Columbia, MD
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| Distinguishing Ontario Ginseng Landraces and Ginseng Species using NMR-Based Metabolomics |
| Dr. Kim Colson and Dr. Jimmy Yuk, Bruker BioSpin Corp., Billerica, MA
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| Development of a Non-invasive Glucose Biosensor for Neonates |
| Sunsanee Kanjananimmanont, Xudong Ge, Govind Rao and Leah Tolosa, University of Maryland, Baltimore County, Baltimore, MD
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| The Development of the Automatic Fluidized Bed Granulator by Monitoring PSD and Control of CPPs |
| Takuya Nagato Toshihiko Shimizu, Powrex Corporation, Saitama Pref, J Japan
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| Low Cost Ratiometric Fluorescence Based Sensor for Aqueous CO2 |
| Dr. Govind Rao, Dr. Yordan Kostov, Dr. Xudong Ge and Nicholas Selock, University of Maryland, Baltimore County, Baltimore, MD
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| Non-invasive Monitoring of O2/CO2 in Neonates |
| Madhubanti Chatterjee, Xudong Ge, Yordan Kostov, Leah Tolosa and Govind Rao, CAST, CBEE, University of Maryland, Baltimore MD
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| Completely Non-Invasive Sensing Method for Dissolved Oxygen and Carbon Dioxide Monitoring in Small Scale Cell Culture Devices |
| Priyanka Amba Gupta, Yordan V. Kostov , Xudong Ge and Govind Rao, University of Maryland, The Center for Advanced Sensor Technology, UMBC, Baltimore, MD
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| The Research and Applications of On-line Near-infrared Spectroscopy Technology in Chinese Petrochemical Industries |
| Chu Xiaoli*, Xu Yupeng, Sun Yanfeng and Lu Wanzhen, Research Institute of Petroleum Processing, Beijing, P.R. China
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| Electrospray Ionization - High Performance Ion Mobility Spectrometry: A Precise and Sensitive Tool for Pharmaceutical Manufacturing Applications |
| Carol Moraff, Excellims Corporation, Acton, MA
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| In-Line Moisture Analysis in a Lab Scale Fluid Bed Dryer Using Diode Array NIRS |
| Robert Mattes, FOSS NIRSystems, Inc., Laurel, MD
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| Association of Gunpowder and its Residue from Three Different Manufacturers using GC/MS |
| Danielle Anderson, Towson University, Towson, MD
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| Enhancement Factors of SERS Substrates |
| Hermes Huang, Chetan Shende, and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown CT
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| B. Anthracis, Ricin Toxin, and Y. Pestis Detection using a Field Portable SERS Assay |
| Frank Inscore, Hermes Huang, Katherine Dana, and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown CT
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| Development of a Novel Valve-less LS-IFC Chip-Digital LAMP for Early Diagnostics of Diseases |
| Ying Mu, Qiangyuan Zhu, Yibo Gao, Hao Ren, Bingwen Yu, Lin Qiu, Sihai Han, Wei Jin, Tao Zhang, Jianguang Zhou and Qinhan Jin*, Research Center for Analytical Instrumentation, Institute of Cyber-Systems and Control, State Key Laboratory of Industrial Control Technology, Zhejiang University, Hangzhou, P. R. China
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| Building Transmission Raman Models for Use in Regulated Content Uniformity Testing |
| Darren Andrews, Cobalt Light Systems, Didcot International, UK
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| Removal of Hexavalent Chromium from Soil using Chelating Agents |
| Jude Ighere and Ramesh Chawla, Department of Chemical Engineering, Howard University, Washington, DC
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| Experimental and Thermodynamic Analysis of Effect of Temperature on Cr (VI) Chelation |
| Jude Ighere, Lauren Reed, Collins Oluka and Ramesh Chawla, Chemical Engineering Laboratory, Howard University, Washington, DC
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| Data Integration Methodology that Leverages Coupled Bioreactor Monitoring Tools, Automated Sampling, and Applied Mathematics to Redefine Bioreactor Operation |
| Lisa Graham, Bend Research, Bend, OR
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| Using a Novel Dielectric Spectroscopy Technology to Monitor Biomass, and Provide Insight into Morphological Changes; A Methodology for Defining Cell State in Real Time |
| Jeff Breit and Brandon Downey, Bend Research, Bend, OR
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| D2-Integration of Sensors, Feeders, Mixer and Software with the Delta V System |
| Leonel Eduardo Quinones Fontalvo, University of Puerto Rico at Mayaguez, Mayaguez, PR
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| Automated On-line Sampling and Nutrient Monitoring for Characterizing Glucose Consumption of Microbial Fermentation Cultures |
| William Miller, Flownamics, Inc., Madison, WI
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| Implementing a Novel OPC Connectivity Solution for Improving Bioprocessing Monitoring |
| William Miller, Flownamics, Inc., Madison, WI
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| Comparing Tablet Dissolution Performance with Information Gleaned from Non-destructive Assessment Methods |
| Pallavi Pawar, Rutgers, The State University of New Jersey, Piscataway, NJ
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| Variograms as a Practical Approach to Determine Optimum Sampling Rate in a Continuous Blending Process |
| Yleana M. Colon, ERC-SOPS, University of Puerto Rico, Mayaguez, PR
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| Powder Feeder Pairing with Downstream Continuous Mixer |
| William Engisch, Rutgers University, Piscataway, NJ
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| Effect of Lubricant Mixing Time and Concentration, Compaction Speed and Compression Force on the Dissolution Profile of a Control Release Formulation |
| Sarang Oka, Rutgers University, Piscataway, NJ
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| Low Shear Continuous Tumble Mixing Characterization |
| Florian-Algarin Miguel Angel, University of Puerto Rico-Mayaguez, Mayaguez, PR
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| Biorelevancy Assessment of Tablets and Oral Films using TIM-1, USP II and NIR Chemical Imaging |
| Krizia M. Karry, ERC-SOPS of Rutgers University, Piscataway, NJ
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| Continuous Powder Blending with In-line NIR as a PAT Tool |
| Juan G. Osorio, Rutgers University, Department of Chemical and Biochemical Engineering, Piscataway, NJ
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| Design of inline PAT tool for Continuous Manufacturing |
| Abhishek Sahay, Rutgers University, Piscataway, NJ
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| Matched Filter Method for Prediction of Blends from a Continuous Mixing Process |
| Jonathan Colon Ortiz, University of Puerto Rico-Mayaguez, Mayaguez, PR
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| Rapid Analysis of In-process Marine Oil by Quality Trait Analysis (QTA) Infrared Spectroscopy |
| Kirsten Kramer, Ching-hui Tseng, Kangming MA, Eurofins Quality Trait Analysis, Cincinnati, OH
|
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| Advances in Process Raman Spectroscopy |
| Sergey Mozharov, University of Washington, Applied Physics Laboratory, Seattle, WA
|
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| SWIR Hyperspectral Imaging for Monitoring Solid Pharmaceutical Formulations |
| Gabor J Kemeny, Gina Stuessy, Middleton Research, Middleton, WI
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