Journal of Process Analytical Chemistry




Table of Contents

Volume/Issue
Title
Authors
6 - 1
PROCESS ANALYTICAL SYSTEMS: A VISION FOR THE FUTURE J.J. Gunnell, P. van Vuuren
ExxonMobil Chemical Company
6 - 1
DEVELOPMENT OF A MULTIVARIATE CALIBRATION MODEL OF AN ORGANIC PROCESS BY NEAR INFRARED SPECTROSCOPY Laila Stordrange, Dick Malthe-Sørenssen, and Ole Martin Høyland
Nycomed Amersham
6 - 1
HARSH ENVIRONMENT MID-INFRARED PROCESS ANALYSIS Troy W. Francisco, Ralph J. Borowski, Kenneth E. Creasy, John L. Welch, and Paul G. Clemmer
Honeywell Specialty Chemicals
6 - 1
A MULTI-CHANNEL EXPLOSION-PROOF PROCESS FT-NIR ANALYZER WITH HIGH SNR AND HIGH RELIABILITY Katsuya Ikezawa, Katsumi Isozaki, Tomoaki Nanko, Hiroshi Koyama, Hisanori Hayashi, and Minoru Akutsu
Yokogawa Electric Corp.
6 - 1
RAMAN SPECTROSCOPY OF METHYLTINS David Lee and Paul Chabot
Elf Atochem North America
6 - 1
POTENTIAL APPLICATIONS OF PROCESS ANALYSIS BY NMR SPECTROMETRY Colin A. McGill, Alison Nordon, and David Littlejohn
Department of Pure and Applied Chemistry/CPACT, University of Strathclyde
6 - 2
MICROCARBONYL SEQUENTIAL INJECTION ANALYZER Don C. Olson and Joanne Wolcott
Global FIA Inc.
6 - 2
POLY-OLEFIN PROCESS GAS ANALYSIS BY MASS SPECTROMETRY Peter Traynor, Robert G. Wright
Thermo ONIX
6 - 2
THE LasIR - A VERSATILE SYSTEM FOR PROCESS CONTROL AND CONTINUOUS EMISSION MONITORING H.I. Schiff, A. Chanda, D.R. Karecki, G.I. Mackay, and J.T. Pisano
Unisearch Associates Inc.
6 - 2
RELATIONSHIPS IN THE PROCESS ANALYSIS INDUSTRY J.J. Gunnell
ExxonMobil Chemical Company
6 - 2
DETECTION OF VOCS IN AIR USING MICROELECTRODE SENSORS P.A. Mosier-Boss and S.H. Lieberman
SPAWAR System Center-San Diego
6 - 2
CERAMIC DOSIMETERS FOR TIME-INTEGRATED CONTAMINANT MONITORING H. Martin, M. Piepenbrink, and P. Grathwohl
University of Tübingen, Geological Institute, Applied Geology Group
6 - 3
DETECTION OF ANIONIC NUTRIENTS USING CATIONIC-COATED, SILVER SERS SUBSTRATES P.A. Mosier-Boss and S.H. Lieberman
SPAWAR System Center-San Diego
6 - 3
ION MOBILITY SPECTROMETRY ARRAYS C.L. Paul Thomas
UMIST
6 - 3
NEW DEVELOPMENTS IN ION MOBILITY SPECTROMETRY Glenn E. Spangler
Technispan LLC
6 - 3
CALIFORNIA ENVIRONMENTAL TECHNOLOGY CERTIFICATION PROGRAM Ruth R. Chang and G. Wolfgang Fuhs
California Environmental Protection Agency
6 - 3
THERMAL SAMPLING TECHNIQUES FOR THE ANALYSIS OF POLYMERS BY GC-MS T.P. Wampler
CDS Analytical, Inc.
6 - 3
INTRINSICALLY VALID VOLATILE ORGANIC COMPOUND MEASUREMENTS Michael Huxham and C.L. Paul Thomas
UMIST
6 - 4
STANDARDIZATION OF NEAR INFRARED SPECTROMETERS OPERATING AT DIFFERENT TEMPERATURE RANGES Silvia Colaiocco M. and Adriano Parisi N.
PDVSA INTEVEP. Research and Technological Support Center
6 - 4
THE MANAGEMENT OF GLOBAL TECHNOLOGY IN THE NEW MILLENNIUM David N. McArthur
University of Nevada
6 - 4
WHY THE NEED FOR A SOUR GAS ANALYZER Ernie Baughman and Bruce McIntosh
Orbital Sciences
6 - 4
HIGH-PERFORMANCE, MULTI-SPECTRAL, FIBER-OPTIC SPECTROPHOTOMETER Patrick E. O'Rourke and Lewis C. Baylor
Equitech Int'l Corp.
6 - 4
SUPPORTED CAPILLARY MEMBRANE SAMPLING SYSTEM (SCMS):RELIABLE SAMPLING FOR DIFFICULT MATRICES D.K. Wolcott, D.C. Olson, and G.D. Marshall
Global FIA Inc.
6 - 4
SPECTROSCOPIC SAMPLE INTERFACING UNDER EXTREME PROCESS CONDITIONS Walter M. Doyle and Norman A. Jennings
Axiom Analytical, Inc.
6 - 4
KINETIC ANALYSIS VIA RAMAN SPECTROSCOPY FOR EFFECTIVE REACTION OPTIMIZATION Arne Zilian and Raylene Dyson
Online Technologies
6 - 4
RAPID ONLINE ANALYSIS OF RCLS AND INERTS USING GC AND GC/MS Eldon R. Baumeister, Eric G. Schmidt, and J. Bryan Vincent
The Dow Chemical Company
6 - 4
AFFINITY BIOSENSORS BASED ON SURFACE PLASMON RESONANCE Jiri Homola, Garet G. Nenninger, and Sinclair S. Yee
Department of Electrical Engineering, University of Washington
6 - 4
TURNKEY INDUSTRIAL SYSTEM FOR MOISTURE ANALYSIS IN CORROSIVE GASES Richard T. Meyer and Jorge E. Perez
CIC Photonics, Inc.
6 - 4
SPECIALTY GAS ANALYSIS SYSTEM CONTROL SOFTWARE Richard T. Meyer and Jorge E. Perez
CIC Photonics, Inc.
6 - 4
AT-PLANT AND ONLINE ANALYSIS: ACHIEVEMENTS AND CHALLENGES John Carey
BP Amoco Chemicals
6 - 4
FIELD PORTABLE BIOSENSORS FOR THE DETECTION OF EXPLOSIVES IN GROUNDWATER P.T. Charles, A.W. Kusterbeck, C.H. Patterson, Jr., J.S. Lundgren, D. B. Holt, and L.C. Shriver-Lake, P.R. Gauger and I.B. Bakatchleva, S.K. van Bergen
Center for Bio/Molecular Science and Engineering, Naval Research Laboratory, GeoCenters, Inc., George Mason University
6 - 4
SNIFFING LANDMINES WITH SURFACE-ENHANCED RAMAN SPECTROSCOPY James M. Sylvia, Kevin M. Spencer, and James A. Janni
EIC Laboratories
6 - 4
EVALUATION OF A FIELD PORTABLE IMMUNOASSAY KIT FOR MONITORING ATRAZINE IN THE POTOMAC WATERSHED James Welch1, George S. Rizzo2 and James A. Jerpe2
Hach Company1 and U.S. EPA Region III2
6 - 4
ULTRALOW DETECTION LIMITS OF VOCS IN SOIL GAS SURVEYS BY AN ON-SITE MOBILE GAS CHROMATOGRAPHY LABORATORY Tony Murray, Dennis Jensen, and Jeff Newton
Florida Department of Environmental Protection, Site Investigation Section
6 - 4
DETECTION OF VOLATILE ORGANIC COMPOUNDS IN SPACECRAFT ENVIRONMENTS USING GAS CHROMATOGRAPHY-ION MOBILITY SPECTROMETRY Thomas Limero and Eric Reese
Wyle Laboratories
6 - 4
ANALYSIS FOR CHEMICAL AGENTS TO SUPPORT THE U.S. EPA'S REGION 5 EMERGENCY RESPONSE BRANCH Amrit S. Boparai, John F. Schneider, and Larry L. Reed
Argonne National Laboratory
6 - 4
QA/QC FOR MANUFACTURE AND MAINTENANCE OF CHEMICAL/BIOLOGICAL FIELD SAMPLING KITS Roberta L. Clay, Rodney D. Hudson, and Patti Riggs
QuickSilver Analytics, Inc.
6 - 4
MEASUREMENTS OF METALLIC MERCURY VAPOR IN INDOOR AIR: A COMPARATIVE STUDY Raj Singhvi1, Rod D. Turpin1, Dennis J. Kalnicky2, and Jay Patel2
1Environmental Response Team Center, U.S. Environmental Protection Agency, 2Lockheed Martin Technology Services Group, Environmental Services/REAC
6 - 4
HEADSPACE SAMPLING BY SOLID PHASE MICROEXTRACTION Zelda Penton
Varian Analytical Instruments
6 - 4
MICROWAVE ACCELERATED EXTRACTION OF PLANT SAMPLES FOR GRAVIMETRIC OIL ANALYSIS Greg LeBlanc, Mike Miller, and Rick Cousins
CEM Corporation
6 - 4
EXTRACTION OF DIESEL RANGE ORGANICS (DRO) AND WASTE OIL ORGANICS (WOO) FROM SOILS AND SEDIMENTS USING ACCELERATED SOLVENT EXTRACTION Bruce E. Richter
Dionex, SLCTC
6 - 4
THE OPTIMIZATION OF THE EXTRACTION OF FAT FROM MEAT AND MEAT PRODUCTS USING CO2 AS A DENSE GAS Al Kaziunas
Applied Separations, Inc.
6 - 4
THE EXTRACTION OF HYDROCARBONS FROM SOLID SAMPLES USING A NEW HOT WATER EXTRACTION INSTRUMENT Yale West
Applied Separations, Inc.
6 - 4
A NEW, FULLY AUTOMATED PRESSURIZED SOLVENT EXTRACTION INSTRUMENT FOR FAST SOLVENT EXTRACTIONS Martin Fetner
Applied Separations, Inc.


Volume/Issue
Title
Authors
7 - 1
PROCESS ANALYTICAL CHEMISTRY…SMARTER, FASTER, STRONGER Kenneth E. Creasy
Honeywell International
7 - 1
ANALYTICAL SCIENCES LEADING MATERIALS DEVELOPMENT A.J. Signorelli, S.A. Curran, and K.O. MacFadden
Honeywell International
7 - 1
ONLINE SPECTROPHOTOMETRIC MEASUREMENTS OF URANIUM AND NITRATE CONCENTRATIONS OF PROCESS SOLUTIONS FOR SAVANNAH RIVER SITE'S H-CANYON Robert Lascola, Ronald R. Livingston, Mark A. Sanders, Jerry E. McCarty, and Judy L. Dunning
Savannah River Technology Center, Westinghouse Savannah River Company
7 - 1
EVANESCENT WAVE CAVITY RING-DOWN SPECTROSCOPY: A FUTURE TECHNOLOGY FOR PROCESS SENSING Andrew C.R. Pipino and Joseph T. Hodges
Process Measurements Division, National Institute of Standards and Technology (NIST)
7 - 1
IN-LINE MOISTURE ANALYSIS IN MIXED ACIDS Troy W. Francisco, Charles L. Redmon, Kenneth E. Creasy, John L. Welch, and William A. Pepe
Honeywell Performance Polymers and Chemicals
7 - 1
ONLINE MONITORING OF PHARMACEUTICAL DRYERS Steven M. Maggard, Denise E. Root, and Myron J. Duell
FOSS NIRSystems, Inc.
7 - 1
MULTI-COMPONENT VOC ANALYSIS BY MASS SPECTROMETRY FOR CONTROLLING EMISSIONS Peter Traynor and Robert G. Wright
Thermo Onix
7 - 2
CORRELATIONS BETWEEN MOLECULAR (RAMAN) AND MACROSCOPIC (RHEOLOGY) DATA FOR PROCESS MONITORING OF THERMOSET (RHEOLOGY) DATA FOR PROCESS MONITORING OF THERMOSET COMPOSITES Stuart Farquharson1, Wayne Smith1, Jennifer Rose2, and Montgomery Shaw3
1Real-Time Analyzers, 1Bohlin Instruments, Inc., 3Polymer Program and Department of Chemical Engineering, Institute of Materials Science, University of Connecticut
7 - 2
INCOMING MATERIALS VALIDATION BY UV/VIS/SWNIR ABSORBANCE: AN ONLINE RECOGNITION METHOD Yoav Barshad and Yael S. Barshad
Applied Analytics, Inc.
7 - 2
EXPERIMENTAL DEMONSTRATION OF A SELF-TUNING FILTER R. Russell Rhinehart
School of Chemical Engineering, Oklahoma State University
7 - 2
RUGGED MICROSENSOR FOR PROCESS STREAM MONITORING U. Bonne, D.Kubisiak, K. Creasy, and T. Francisco
Honeywell Laboratories
7 - 2
AUTOMATED REAL-TIME MONITORING OF PHOSPHINE CONCENTRATIONS OUTSIDE LARGE FUMIGATED TOBACCO WAREHOUSES USING GC/PFPD Tommy G. Thorn, Jr.1, Robert D. Stevens1, Donald P. Segers2 and Sandra T. Macon2
1Lorillard Tobacco Co., 2CMS Field Products, O.I. Analytical
7 - 2
AIR SEPARATION PROCESS ANALYSIS BY MASS SPECTROMETRY Peter Traynor and Robert G. Wright
Thermo Onix
7 - 2
AUTOMATED STEADY STATE IDENTIFICATION: EXPERIMENTAL DEMONSTRATION R. Russell Rhinehart
School of Chemical Engineering, Oklahoma State University
7 - 3
MONITORING METAL COMPLEX CONTAMINANTS IN WATER BY SURFACE-ENHANCED RAMAN SPECTROSCOPY Stuart Farquharson, Wayne W. Smith, and Yuan-Hsiang Lee
Real-Time Analyzers
7 - 3
CONSTRUCTION AND TESTING OF AN 8-PORT AIR SAMPLING DEVICE Douglas C. Stewart, Phil Buckley, and Rob Tisdale
Midwest Research Institute
7 - 3
ONLINE BUTTER ANALYSIS BY NIR Andrew Wallace
Bran+Luebbe Ltd.
7 - 3
HARVESTING VALUE FROM MEMBERSHIP IN UNIVERSITY-INDUSTRY CONSORTIA Michael Blackburn
Cargill, Inc.
7 - 3
FUTURE OF MICROMACHINED INSTRUMENTS IN PROCESS ANALYSIS Jerry W. Evans
Thermo Onix
7 - 3
INSTRUMENTATION AND AUTOMATION TESTING ORGANIZATIONS HOW THEY WORK AND WHY THEY ARE IMPORTANT TO THE INDUSTRY Steven J. Gluck1, Tony Palmer2 and Maureen Ross2
1The Dow Chemical Company, 2Instrumentation Testing Association
7 - 3
THE DEVELOPMENT OF NIR MICROSCOPY FOR PROCESS CONTROL IN PHARMACEUTICAL MANUFACTURING Fiona C. Clarke1, Stephen V. Hammond1 and Charlotte Mattisson2
1Pfizer Ltd., 2PharmaVision Systems AB
7 - 4
RAPID DETECTION OF CHEMICAL AGENT RESIDUES ON ENVIRONMENTAL SURFACES USING AN ION TRAP SIMS Gary Gresham, Gary S. Groenewold, Jani C. Ingram, Anthony D. Appelhans, David A. Dahl, John Olson, and James E. Delmore
Idaho National Engineering and Environmental Laboratory
7 - 4
AUTOMATED ONLINE IDENTIFICATION AND MONITORING OF IMPURITIES IN GASES James G. Moncur
Trace Analytical Inc.
7 - 4
A VISUAL METHOD FOR THE DETECTION OF ARSENIC 0-500 mG/LITER Dan Kroll
Hach Company
7 - 4
SINGLE CHROMATOGRAPHIC SEPARATION SCHEME FOR TRACE LEVEL ANALYSIS BY ICP-MS OF TH, U, NP, AND PU ISOTOPES IN NICKEL METAL J.M. Giaquinto, L.D. Bible, and J.M. Keller
Chemical and Analytical Sciences Division, Oak Ridge National Laboratory
7 - 4
FIELD-PORTABLE, HIGH-SPEED GC/TOFMS Jack A. Syage, Brian J. Nies, Matthew D. Evans, and Karl A. Hanold
Syagen Technology, Inc.
7 - 4
WHY YOU SHOULD CONSIDER LWR FOR YOUR APPLICATION S. Chang, B. McIntosh, E. Baughman, and L. McDermott
Orbital Sciences
7 - 4
IN-LINE INFRARED SENSORS COVERING THE MID-IR FROM 2 TO 14mM (5000 TO 700CM-1) Paul Wilks
Wilks Enterprise, Inc.
7 - 4
AT-LINE: A PRACTICAL APPLICATION OF SMART MODULAR SAMPLING COMPONENTS J. Kelley Bell
ABB Automation - Analytical Division
7 - 4
ONLINE NIR PHOTOMETER APPLICATIONS Thomas M. Cardis
ABB Analytical Division
7 - 4
THE ONLINE MEASUREMENT OF TOTAL SULFUR IN MOTOR FUEL WITH PROCESS GAS CHROMATOGRAPHY Ulrich Gokeler1, Friedhelm Mueller2 and Udo Offermanns2
1Siemens Applied Automation, 2Siemens AG
7 - 4
ONLINE HPLC FOR MONITORING AND CONTROL OF METABOLISM IN MAMMALIAN CELL CULTURE Tina M. Larson
Manufacturing Science & Technology, Genentech, Inc.
7 - 4
THE POWER AND PERFORMANCE OF CAPILLARY COLUMNS IN PROCESS GAS CHROMATOGRAPHY Ulrich Gokeler1, Torsten Maurer2
1Siemens Applied Automation, 2Siemens AG
7 - 4
ACCELERATED SOLVENT EXTRACTION FOR SAMPLE PREPARATION OF CHEMICAL WEAPON DEGRADATION COMPOUNDS Jay D. Sheffer, Donna E. Swartz, and Spiros Z. Manolakos
Constellation Technology Corporation
7 - 4
ELECTRICALLY-CONDUCTIVE POLYMERS FOR CHEMICAL AGENT WATER MONITORING Erik S. Handy
Triton Systems, Inc.
7 - 4
A PORTABLE CAPILLARY ELECTROPHORESIS INSTRUMENT T. Kappes, B. Galliker, M.A. Schwarz, and P. C. Hauser
University of Basel, Department of Chemistry
7 - 4
AUTOMATED EXTRACTION OF LARGE SAMPLES FOR ENVIRONMENTAL ANALYSIS USING ACCELERATED SOLVENT EXTRACTION (ASE) B.E. Richter, J.L. Ezzell, E.S. Francis, and L. Covino
Dionex, SLCTC
7 - 4
APPLICATION OF SOLID-PHASE MICROEXTRACTION FOR LOW PARTS-PER-TRILLION LEVEL ANALYSIS OF VOLATILE ORGANIC COMPOUNDS IN HUMAN BLOOD: CONTAMINATION AND SAMPLE PREPARATION Frederick L. Cardinali, David L. Ashley, Joe V. Wooten, Joan M. McCraw, and Sharon W. Lemire
U.S. Department of Health and Human Services, Division of Environmental Health Laboratory Sciences
7 - 4
THE USE OF SOLID PHASE MICROEXTRACTION (SPME) FOR REMOTE SAMPLING Raymond Mindrup and Robert Shirey
Supelco, Inc.
7 - 4
SOME APPLICATIONS OF AUTOMATED SOLID-PHASE MICROEXTRACTION: BLOOD ALCOHOL, VOLATILES IN BEER, AND MONOMERS IN POLYMERS Zelda Penton
Varian Analytical Instruments


Volume/Issue
Title
Authors
8 - 1
A VIRTUAL EMPLOYEE TO TRIGGER EXPERIMENTAL CONDITIONS John T. Szela1 and R. Russell Rhinehart2
1Accenture, 2School of Chemical Engineering, Oklahoma State University
8 - 1
THE APPLICATION OF PROCESS MASS SPECTROMETRY TO FUMED SILICA PRODUCTION Peter Traynor, Steven Trimuar, and Robert G. Wright
Thermo Electron Corporation
8 - 1
A CHEMICAL SENSOR BASED SCHEME TO EVALUATE PACKAGING CONTAINMENT EFFECTIVENESS – PART 1: DEVELOPMENT AND OPTIMIZATION Gregory K. Webster1, Douglas A. Farrand1, and Mark A. Litchman2
1Pfizer Global Research and Development, 2Pfizer Global Manufacturing
8 - 1
PROCESS AND ENVIRONMENTAL APPLICATIONS OF GAS CHROMATOGRAPHY WITH THE REDUCTION GAS DETECTOR Marco Succi1 and James G. Moncur2
1SAES Getters S.p.A., 2Independent Consultant
8 - 1
DETERMINATION OF ASPHALTENE CONTENT IN CRUDE OIL BY ATTENUATED TOTAL REFLECTANCE INFRARED SPECTROSCOPY AND NEURAL NETWORKS ALGORITHMS Silvia Colaiocco M. and Manuel Farrera
PDVSA INTEVEP
8 - 2
PROCESS ANALYZERS FOR PURIFIED BULK GAS QC/QA: ENTERING THE PPT RANGE Marco Succi1, James G. Moncur2 and William L. Robinson2
1SAES Getters S.p.A., 2 Independent Consultants
8 - 2
A DYNAMIC APPROACH TO SITE CHARACTERIZATION AND CLEANUP AT SITES CONTAMINATED WITH HAZARDOUS CHEMICALS IN CONNECTICUT Farhad Nadim1, Robert J. Carley1, Christopher Perkins1, Peter Zack2 and Frank Bartolomeo2
1The Environmental Research Institute University of Connecticut, 2Connecticut Department of Environmental Protection, Underground Storage Tank Program
8 - 2
ION MOBILITY SPECTROMETRY: A NOVEL TECHNOLOGY FOR PROCESS ANALYSIS Jörg Ingo Baumbach1 and Hartwig Schmidt1, Stefanie Sielemann2 and Peter Pilzecker2
1Institute of Spectrochemistry and Applied Spectroscopy (ISAS), 2G.A.S. Gesellschaft für Analytische Sensorsysteme GmbH
8 - 2
OPEN PATH FOURIER TRANSFORM INFRARED SPECTROMETER APPLICATIONS FOR ENVIRONMENTAL MONITORING OF CHEMICAL WARFARE AGENTS Uday Mehta and Christopher C. Keiser
U.S. Army Soldier and Biological Chemical Command


Volume/Issue
Title
Authors
9 - 1
THE IMPACT OF PROCESS ANALYTICAL TECHNOLOGY IN PHARMACEUTICAL CHEMICAL PROCESS DEVELOPMENT Paul A. David, Robert Roginski, Steve Doherty, Jodi Moe
Pfizer Global Research and Development
9 - 1
PHASED: A FASTER, SMARTER AND MORE AFFORDABLE GAS ANALYSIS DEVICE Ulrich Bonne and Robert E. Higashi
Honeywell Laboratories
9 - 1
ENHANCING THE INFORMATION IN PROCESS ACOUSTICS DATA USING SIMPLE DATA PRE-TREATMENT Geir Rune Flten and Anthony D. Walmsley
CPACT, The University of Hull, Department of Chemistry
9 - 1
A CHEMICAL SENSOR BASED SCHEME TO EVALUATE PACKAGING CONTAINMENT EFFECTIVENESS PART 2: SCALE-UP AND QUALIFICATION OF THE INSPECTION SCHEME Gregory K. Webster1, Douglas A. Farrand1, and Mark A. Litchman2
1Pfizer Global Research and Development, 2Pfizer Global Manufacturing
9 - 1
A PORTABLE DEVICE FOR REAL-TIME GAS ANALYSIS USING ION-SELECTIVE ELECTRODES Steven H. Hoke1, Mark F. Arnold2,Michael A. Chapman3
1U. S. Army Center for Health Promotion and Preventive Medicine,2U. S. Army Medical Materiel Development Activity,3U. S. Army Aberdeen Test Center
9 - 2
ODOR CONCENTRATION TO ENHANCE ELECTRONIC NOSE PERFORMANCE Carrie M. Thomas and John F. Schneider
Argonne National Laboratory, Chemical Analysis and Research Team
9 - 2
ANALYTICAL PERFORMANCE OF A HANDHELD EDXRF SPECTROMETER WITH MINIATURE X-RAY TUBE EXCITATION Volker Thomsen and Debbie Schatzlein
NITON LLC
9 - 2
AT-LINE PROCESS CONTROL OF THE MOISTURE AND FINISH-ON-FIBER OF TEXTILE PRODUCTS BY NIR James E. Rodgers, Pan Sukpaladisai, Rafael Barraza and Chuck Horton
Solutia, Inc.
9 - 2
MRI FOR PROCESS ANALYSIS: CO-ROTATING TWIN SCREW EXTRUDER Young J. Choi, Michael J. McCarthy and Kathryn L. McCarthy
University of California, Department of Food Science and Technology, Department of Biological and Agricultural Engineering


Volume/Issue
Title
Authors
10 - 1
PREDICTING PULP QUALITY FROM PROCESS ACOUSTIC MEASUREMENTS ON A MEDIUM CONSISTENCY PULP STREAM Anders Bjork and Lars-Goran Danielsson
KTH Chemistry, Analytical Chemistry, Royal Institue of Technology
10 - 1
FIELD CHEMICAL ANALYSIS AND TECHNOLOGY: FOR LOCATING ENTRAPPED PEOPLE Milt Statheropoulos and Agapios Agapiou
School of Chemical Engineering, National Technical University of Athens (NTUA)
10 - 1
IN-SITU FTIR MONITORING OF SOLVENT-DRUG MATRIXES DURING CRYSTALLIZATION UNIT OPERATIONS FROM LAB TO PRODUCTION Kyle Leeman, Mike Preigh, Matt Weekly, Paul Ahlijanian, John Tucker, Ann Serdakowski
Pfizer Inc. Global Research, Analytical Research and Development
10 - 1
Evaluation of an Electronic Nose with Sample Preconcentration for the Detection of Toxic Industrial Chemicals John F. Schneider1, Carrie M. Thomas2 and Steven Sunshine2
1 Argonne National Laboratory, 2Smiths Detection
10 - 2
APPLICATION OF A LOW COST AMPEROMETRIC SENSOR FOR DETECTION OF ALCOHOLS IN PROCESS RELATED HEADSPACE APPLICATIONS Gregory K. Webster1, Tracy Hobson2, W. Brian Holzheuer2, Joseph R. Stetter3 and William.J. Buttner3
1Summit Analytical Services, 2Pfizer Global Research and Development , 3The International Center for Sensor Science and Engineering, Illinois Institute of Technology
10 - 2
MANAGING THE RISK OF RESIDUAL MOISTURE ON LYOPHILIZED PRODUCTS FROM ELASTOMER CLOSURES Thomas A. Jennings
10 - 2
A MOBILE VIRTUAL INTERFACE FOR THE MONITORING AND CONTROL OF CHEMICAL ANALYSIS SYSTEMS: APPLICATION TO A WORT FERMENTATION PROCESS A. Bonastre1, R. Ors 1, J.V. Capella 1, M Peris 2
1 Department of Computer Engineering. Polytechnic University of Valencia. Valencia, Spain, 2 Department of Chemistry. Polytechnic University of Valencia. Valencia. Spain


Volume/Issue
Title
Authors
11 - 1
PTR-MS TECHNOLOGY FOR PROCESS MONITORING AND CONTROL IN BIOTECHNOLOGY Wolfgang Singer1, Rene Gutmann1, Jrgen Dunkl1, Armin Hansel12
1Ionimed Analytik GmbH, 2Institute of Ion Physics and Applied Physics, University of Innsbruck, Innsbruck, Austria


Volume/Issue
Title
Authors
12 -
IFPAC-2014 Special Issue
12 - 1
IFPAC-2014 Special Issue Wednesday AM January 22, 2014
12 - 1
IFPAC-2014 Co-Chair Introductions Paul Vahey1, Sharmista Chatterjee2, Gawayne Mahboubian-Jones3, Mark A. LaPack4
1The Boeing Company, Boeing Research and Technology, Seattle, WA, 2FDA, CDER, OPS, ONDQA, Silver Spring, MD, 3Philip Morris International, Neuchatel, Switzerland, 4Eli Lilly and Company, Indianapolis, IN
12 - 1
Leveraging Big Data in Real-Time: Moving from Inspect & Reject to Predict & Prevent Jim Petrusich
Northwest Analytics, Portland, OR
12 - 1
CDER's Office of Pharmaceutical Quality (OPQ): Delivering on the 21st Century Quality Goals Lawrence Yu
FDA, Silver Spring, MD
12 - 1
Rapid Screening Methods and Spectral Library Development Jason D. Rodriguez
FDA, St. Louis, MO
12 - 2
IFPAC-2014 Special Issue Wednesday PM, January 22, 2014
12 - 2
A QbD Approach to Continuous Tablet Manufacture Tim Freeman
Freeman Technology, Inc., Tewkesbury, Gloucestershire, UK
12 - 2
Rapid/Automated Environmental Monitoring on the Manufacturing Floor Amy McDaniel
Pfizer, Sanford, NC
12 - 2
A Rapid Microbiological Method-RMS for Application in Manufacturing Bill Puent and J.P. Jiang
Instant BioScan, Tucson, AZ
12 - 2
Rapid Micro Methods for Manufacturing Jeffrey W. Weber
Pfizer, Kalamazoo, MI
12 - 2
Quality Risk Management and Submission Strategies for Breakthrough Therapies Sarah Pope Miksinski
Division of New Drug Quality Assessment, ONDQA/OPS/CDER/FDA, Silver Spring, MD
12 - 2
Lifecycle Product Quality Risk Management Richard L. Friedman
Office of Manufacturing & Product Quality, Office of Compliance, FDA, Silver Spring, MD
12 - 2
Risk Assessment for QbD: 3 Reasons Why FMEA Fails Sun K. Kim
Bayer Healthcare, Berkeley, CA
12 - 2
General Update about the FDA-EMA QbD Pilot Evdokia Korakianiti
EMA, UK
12 - 2
Update on Lessons Learned from the EMA-FDA QbD Pilot Sharmista Chatterjee
ONDQA/OPS/CDER/FDA, Silver Spring, MD
12 - 2
FDA-EMA Parallel Assessment Pilot John Groskoph
Pfizer, Peapack, NJ
12 - 2
Industry Experience Regarding Consultative Advice Pathway Stephanie Krogmeier
Vertex Pharmaceutical, Cambridge, MA
12 - 3
IFPAC-2014 Special Issue Thursday, January 23, 2014
12 - 3
Scale-up Verification using Multivariate Analysis Christian Airiau
GlaxoSmithKline, King of Prussia, PA
12 - 3
PAT-enabled Design Space Definition and Process Control for an API Through Process George Zhou, Shane Grosser, Paul Fernandez, Marguerite Mohan, Aaron Moment, Tseng-En Hu and John Higgins
Merck & Company, Rahway, NJ
12 - 3
Equivalency Testing: The Roles of Assay Precision, Truth, Bias, Tolerance, Risk and Control Strategy in Setting Equivalence Margins Kim E. Zerba, Sutan Wu1 and Gary McGeorge
Bristol-Myers Squibb, New Brunswick, NJ, 1inVentiv Health Clinical, Lake Mary, FL
12 - 3
The PAT Model Lifecycle: Experience with Validation and On-going Verification John Higgins, Zhihao Lin, Charles E. Miller, Nathan Pixley, Manoharan Ramasamy, George Zhou and Niya Bowers
Merck & Company, West Point, PA
12 - 3
Mixed Hierarchical Models for the Process Environment Barry M. Wise, Robert T. Roginski, Neal B. Gallagher and Jeremy M. Shaver
Eigenvector Research, Inc., Wenatchee, WA
12 - 3
Simple Chemometrics Application for Complex Development Issues-Criticality of the Pre-processing Step Christian Airiau
GlaxoSmithKline, King of Prussia, PA
12 - 3
Bus Integration and Calibration Record Retrieval Matt MacConnell
Air Products, Allentown, PA
12 - 4
IFPAC-2014 Special Issue Thursday PM, January 23, 2014
12 - 4
Application of the QbD (Quality by Design) Approach for Coating Drug Eluting Stents (DES) Martin K. McDermott1 and Sharmista Chatterjee2
1FDA/CDRH/OSEL/DCMS, Silver Spring, MD, 2FDA/CDER/OPS/ONDQA, Silver Spring, MD
12 - 4
Real World Application of QbD Principals to Development of Dry Powder Inhaled Products Mark Whitaker
GlaxoSmithKline
12 - 4
Assuring Drug Product Quality and Patient Safety through the Application of QbD to Packaging and Delivery Systems Diane M. Paskiet
West Pharmaceutical Services, Inc., Exton, PA
12 - 4
MSAT Strategies for Manufacturing Excellence in Pharma and BioPharma: QbD 2.0 Jose C. Menezes, Joao E. Machado and Pedro F. Felizardo
4Tune Engineering Ltd., Lisbon, Portugal
12 - 4
Data Management and Control Strategies for Continuous BioProduction Kjell Francois
Siemens, Brussels, Belgium
12 - 4
A Multivariate Calibration Model Maintenance Road Map Barry M. Wise and Robert T. Roginski
Eigenvector Research, Inc., Wenatchee, WA
12 - 4
Process Analyzer Continuous Verification Jason E. Dickens
GlaxoSmithKline, Durham, NC
12 - 4
Clinical Relevant Specifications (CRS): A Regulatory Perspective Richard (Rik) Lostritto
ONDQA/CDER/FDA, Silver Spring, MD
12 - 4
Use Process Capability to Ensure Product Quality Daniel Y. Peng
OPS/CDER/FDA, Silver Spring, MD
12 - 4
Product Robustness: Reducing Variability and Ensuring Delivery of Superior Quality Products to Patients Dafni Bika, Jennifer Walsh and Tara Nestor
Bristol-Myers Squibb
12 - 4
Process Capability Applications Brian Eden and Kenneth Cote
Mylan Pharmaceuticals, Pittsburgh, PA
12 - 4
Process Capabilities - Generic Industry Perspective Alpesh Patel
Amneal Pharmaceuticals, Hauppauge, NY
12 - 4
Process Capability: Understanding the Science and the Statistics Michael Choi
Particle Coating Technology Solutions (PCTS, Inc.)
12 - 4
Distillation Monitoring with NIR Spectroscopy-From Laboratory Experiments to Manufacturing Christian Lautz
F. Hoffmann-La Roche, Ltd., Basel, Switzerland
12 - 4
Siemens Process Sample System Smart Components: Aiding and Abetting Michael Hoffman
Siemens, Houston, TX
12 - 4
Airborne Ultrasound: The Next Wave in Process Analytical Technologies Oliver Stauffer
Packaging Technologies & Inspection, Tuckahoe, NY
12 - 4
Multiplexed Imaging Spectrometer Instrument for PAT Rudy Hofmeister
H2Optx, Inc., San Jose, CA
12 - 4
Experimental and Computational Techniques for Overcoming the Challenges of Quantitative Crystallinity Measurements using Terahertz Spectroscopy Mark Sullivan1, Edward King1, David Heaps1, Xiao Hua Zhou1, Richard McKay1 and Wiphusanee Dendamrongvit2
1Advantest America, Inc., Princeton, NJ, 2Oncobiologies, Inc., Cranbury, NJ
12 - 4
New Small Spectrometer Concepts Covering the Ultraviolet to the Mid-Infrared John Coates
Coates Consulting LLC, Newtown, CT
12 - 5
IFPAC-2014 Special Issue Friday AM, January 24, 2014
12 - 5
Implementation of QbD for Analytical Methods-Session Introduction Sonja Sekulic
Pfizer, Groton, CT
12 - 5
Application of Analytical Method QbD within GSK Phil Borman
GlaxoSmithKline
12 - 5
QbD Approach and Analytical Procedures Yubing Tang
FDA, Silver Spring, MD
12 - 5
Examples of Applying Quality by Design Principles to Analytical Methods Kimber Barnett
Pfizer
12 - 5
Progressing Towards Operational Flexibility in Analytical Procedures-Global Change Control and Regulatory Expectations Joerg Hoffman
Merck
12 - 5
FDA-EMA Collaborative Research on Analytical Method QbD: Project Status John Kauffman and Dan Mans
FDA, St. Louis, MO
12 - 5
Developing an Analytical Impurity Control Strategy Using QbD Mark Argentine
Lilly, Indianapolis, IN
12 - 5
NIR-Spectroscopy for Bioprocess Monitoring and Control Dan Kopec
Sartorius Stedim North America, Bohemia, NY
12 - 5
Introduction to Spatially Resolved Spectroscopy for Tablet and Biotech Application of Critical Physical and Chemical Attributes Boris Larcheveque
INDATECH, Prades le Lez, France
12 - 5
On-Line Multivariate Analysis (MVDA): A Platform PAT Tool for Vaccines and Biologics John Higgins, Louis Obando, Charles Miller and Niya Bowers
Merck, West Point, PA
12 - 5
An Automated Bioreactor Sampling Solution for Assuring On-line PAT Analytical Fidelity William Miller, Lucas Schimmelpfenning, Paul Strand and Michael Biksacky
Flownamics, Inc., Madison, WI
12 - 5
Pharmaceutical Quality Control of Complex Botanicals Peter Gibson
GW Pharmaceuticals, Salisbury, UK
12 - 5
QbD Implementation in Generic Industry: Are we there yet? Inna Ben-Anat
Teva Pharmaceuticals
12 - 5
A QbD Approach to the Development of a Generic Transdermal or Topical Product Mike Fowler
Actavis, Salt Lake City, UT
12 - 5
Scaling up QbD Tamar Ben-Avi
Taro Pharmaceuticals
12 - 5
(How To) PAT in Generic Industry - Case Studies Marta Lichtig
Taro Pharmaceuticals
12 - 5
The use of Thermal Imaging for PAT Application in Packaging Eran Sinbar
DIR Technologies, Haifa, Israel
12 - 5
PAT in ANDA Submissions Geoffrey Wu
FDA/CDER/OGD, Rockville, MD
12 - 5
QbD Update and Observations of Recent ANDA Submissions Jennifer Maguire and Daniel Peng
FDA, Rockville, MD
12 - 5
A New Window into Process Data - Descriptive Data Analysis of Multi-block Data Ing-Marie Lindstrom
MKS Umetrics, Malmo, Sweden
12 - 5
Statistical Approaches for PPQ: Options and Outcomes Tara Scherder
Arlenda
12 - 5
Breakthrough Therapy Designation: Small Molecule Considerations John Groskoph
Pfizer, Peapack, NJ
12 - 5
Industry Case Study: Continued Process Verification (CPV) for a Biotech Product Beth Junker
Merck & Company
12 - 5
Risk Benefit Considerations in Accelerated CMC/GMP Development and Launch of Breakthrough Therapy Products Earl S. Dye
Genentech
12 - 5
Detecting the Presence/Absence of Inclusions in Ice Cream using Guided Microwave Spectrometry Michelle Schultz
Thermo Fisher Scientific, Minneapolis, MN
12 - 5
Real-time Tablet API Analysis: A Comparison of a Palm-size NIR Spectrometer to HPLC Method Chris Pederson1, Nada O'Brien1 and Benoit Igne2
1JDS Uniphase Corp., Santa Rosa, CA, 2Duquesne University, Pittsburgh, PA
12 - 5
A Review of New Small-Scale Technologies for Near Infrared Measurements John Coates
Coates Consulting LLC, Newtown, CT
12 - 6
IFPAC-2014 Special Issue Friday PM, January 24, 2014
12 - 6
APOTEX's Perspective on Question Based Review of ANDAs Kiran Krishnan
APOTEX, Richmond Hill, Canada
12 - 6
Implementation of Capacitance Probes for Continuous Viable Cell Density Measurements for 2K Manufacturing Fed-Batch Processes at Biogen Idec Jason Wong
Biogen, Idec
12 - 6
Control Loops for Glucose Feed in Cell Culture and Microbial Fermentation Bioprocesses Based on Online Measurement Henry Weichert
Sartorius Stedim Biotech GmbH, Gottingen, Germany
12 - 6
Statistics and Pharmaceutical Quality Karthik Iyer
CDER/OC/OMPQ/FDA, Silver Spring, MD
12 - 6
Relating Blend Uniformity Specification to the Finished Product Assay, Dissolution and its Biorelevance Ravi Tejwani
Bristol-Myers Squibb Co., New Brunswick, NJ
12 - 6
Some Recent Examples of Product and Process Understanding in CDER Mansoor A. Khan
FDA/OTR, Silver Spring, MD
12 - 6
PAT Data Management to Enable Advanced Process Monitoring and Control on Hot Melt Extrusion Lines Kjell Francois
Siemens, Brussels, Belgium
12 - 6
Chemometrics for Analysis of NIR Spectra on Pharmaceutical Oral Dosages William J. Welsh1,2, Sastry Isukapalli2, Rodolfo Romanach3, Bozena Michniak-Kohn1, Alberto Cuitino1, Fernando Muzzio1
1Rutgers-The State University of New Jersey, Piscataway, NJ, 2Snowdon, Inc., Princeton, NJ, 3UPR, Mayaguez, Puerto Rico
12 - 6
Tools for Streamlined Analysis of On-Line Mass Spectroscopic Data Mark A. LaPack1 and Robert T. Roginski2
1Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN, 2Eigenvector Research, Incorporated, Wenatchee, WA
12 - 6
Characterization and Quantitation of Supplement Samples Using TGA-MS Charles De Carlo
Extrel CMS, Pittsburgh, PA
12 - 6
Nanomaterial Screening by MS for Carbon Sequestration Stefano Brandani1, Chiara Ferrari1, Enzo Mangano1 and Tony Slapikas2
1University of Edinburgh, School of Engineering, Edinburgh, 2AMETEK Process Instruments, Pittsburgh, PA
12 - 6
From laboratory Models Calibration to Online Low-cost Process Monitoring of Diesel Refinery Pilot Units Noemie Caillo1, Franck Baco-Antoniali1, Olivier Delpoux1, M. Lacoue-Negre2, K Stiti2, A. Bonhomme2
1IFPEN, Solaize, France, 2 ISA.


Volume/Issue
Title
Authors
13 -
IFPAC-2015 Special Issue
13 - 1
IFPAC-2015 Special Issue Sunday PM, January 25, 2015
13 - 1
An FDA Perspective on Post-Approval Change Management for PAT and RTRT Christine M. V. Moore, Ph.D., Acting Director
Office of Process and Facilities, FDA/CDER/OPQ, Silver Spring, MD
13 - 1
Chemometrics Models over the Decades: Strategies for Long-Term Support Mary Beth Seasholtz and Wendy Flory
The Dow Chemical Company, Midland, MI
13 - 1
The use of Models in Control Strategies-Life Cycle Management and Registration Considerations Gert Thurau
Hoffmann-LaRoche, Basel, Switzerland
13 - 2
IFPAC-2015 Special Issue Monday AM, January 26, 2015
13 - 2
IFPAC-2015 Co-Chair Introductions Scott Armstrong1, John Kauffman2, G.K. Raju3, Martin Warman4
1ExxonMobil, Baton Rouge, LA, 2FDA,CDER,OPS,OTR,DPA, St. Louis, MO, 3Light Pharma, Cambridge, MA, 4Vertex Pharmaceuticals, Boston, MA
13 - 2
FDA Quality Oversight: One Quality Voice Lawrence Yu, Ph.D., Deputy Director
Office of Pharmaceutical Quality FDA Center for Drug Evaluation and Research
13 - 2
Risk and Knowledge Management Kevin Nepveux
Pfizer
13 - 2
Towards Making Biologic Drugs on Demand J. Christopher Love
MIT, Cambridge, MA
13 - 2
Process Analyzer Technology and Workforce Needs to Support Business Growth Don Bartusiak
ExxonMobil
13 - 3
IFPAC-2015 Special Issue Monday PM, January 26, 2015
13 - 3
Update on FDA-EMA QbD Pilot Sharmista Chatterjee, Ph.D., Branch Chief (Acting)1, Dolores Hernn, Ph.D.2
1Office of Process & Facility Office of Pharmaceutical Quality, CDER, FDA, 2Quality Office Specialized Scientific Disciplines, European Medicines Agency
13 - 3
Risk Based Review and the Management of Residual Uncertainty in the Regulation of Biological Products Jeffrey C. Baker, Ph.D., Deputy Director
Office of Biotechnology Products, CDER, OBP, FDA, Silver Spring, MD
13 - 3
Innovative Multipurpose vis-NIR Spectroscopy for Real-time Physical and Chemical Characteristics of Dense Media & Counterfeit Detection Yi-chieh (Claudia) Chen
Department of Chemical Engineering, University of Strathclyde, Glasgow, UK
13 - 3
Rasing the Bar through Product Robustness with Enhanced Process Knowledge and Understanding Jennifer Walsh, Dafni Bika, Ph.D. and Tara Nestor
Manufacturing Technology, Bristol-Myers Squibb, New Brunswick, NJ
13 - 3
Advanced Concepts for Change Control of Analytical Procedures with ICH Q12 Coming Jrg Hoffmann
Merck, KGaA, Germany
13 - 3
A Qualitative Approach to Bioprocess Monitoring and Decision Making with NIR-Spectroscopy and MVDA Dan Kopec
Sartorius Stedim North America, Bohemia, NY
13 - 3
Rapid Microbiological Monitoring (RMM) Technologies for Purified Water Monitoring Shinsuke Yamasaki1, Scott Morris2
1Azbil Corporation, Japan, 2BioVigilant, Tucson, AZ
13 - 3
Implementation of Enterprise Manufacturing Intelligence: Progress on the Road to Total Data Domination Mary Beth Seasholtz, Bryant LaFreniere and Lloyd F. Colegrove
The Dow Chemical Company, Midland, MI
13 - 3
Evaluating the Design Space for the Batch Manufacture of an OTC Medicine Tim Freeman
Freeman Technology, UK
13 - 3
Utilisation of Raman Spectroscopy for Primary and Secondary Pharmaceutical Development Allyson McIntyre1, Richard Hart1, Nicholas Pedge1, Anders Sparn2, Olof Svensson2, Magnus Fransson
1AstraZeneca, Macclesfield, UK, 2AstraZeneca R&D Mlndal
13 - 3
Time-Resolved Photoluminescence Suppressed Raman Spectroscopy of Drugs Tatu Rojalin1, Mari Tenhunen2, Clare J. Strachan1, Marjo Yliperttula1
1University of Helsinki, Finland, 2VTT, Oulu, Finland
13 - 3
Chemometrics Models over the Decades: Strategies for Long-Term Support Wendy Flory and Mary Beth Seasholtz
The Dow Chemical Company, Midland, MI
13 - 3
Compact Hydrogen Peroxide Sensor for Sterilization Cycle Monitoring Krishnan R. Parameswaran, Clinton J. Smith, Kristin L. Galbally-Kinney and William J. Kessler
Physical Sciences, Inc., Andover, MA
13 - 3
Drag Force Flow Sensor as a Tool for Real-Time Assessment of Granule Densification in High Shear Wet Granulation: Effect of Process Parameters and Application to Scale-up in Placebo and Brivanib Alaninate Formulations Ajit S. Narang1, Valery A. Sheverev2, Vadim Stepaniuk2, Sherif Badawy1, Tim Stevens3, Kevin Macias3, Avi Wolf1, Preetanshu Pandey1, Dilbir Bindra1, and Sailesh Varia1
1Bristol-Myers Squibb, Drug Product Science & Technology, New Brunswick, NJ, 2Lenterra, Inc., Newark, NJ, 3Bristol-Myers Squibb, Analytical & Bioanalytical Development, New Brunswick, NJ
13 - 4
IFPAC-2015 Special Issue Tuesday AM, January 27, 2015
13 - 4
Risk-Based Control Strategy for Biologics Gert Thurau
Hoffmann-LaRoche, Basel, Switzerland
13 - 4
Recent Activities conducted by PAT committee of JSPME for Implementation of PAT and QbD in a Japanese Pharmaceutical Society Takayuki Murakami
Sumitomo Dainippon Pharma Co., Ltd. and PAT committee of Japan Society of Pharmaceutical Machinery and Engineering (JSPME), Osaka, Japan
13 - 4
Manufacturing Process Control with PAT: Substitution of off-line HPLC & GC by in-line IR Spectroscopy Christian Lautz
Hoffmann-LaRoche, Ltd., Basel, Switzerland
13 - 4
Using Risk Assessment Tools to Lead Development into the Right Direction: A Case Study Petra Brozic, Senior Scientist, Pharmaceutical Development
Lek Pharmaceuticals d.d., a Sandoz Company
13 - 4
Lifecycle of NIR Analytical Methods - Regulatory Perspective Bogdan Kurtyka, Ph.D.
FDA/OPQ/OPF, Silver Spring, MD
13 - 4
Single Use Capacitance Measurements of Viable Cell Volume Stuart Tindal1, Markus Weise2, Jochen Scholz1, Sven Gro1, Henry Weichert1, Thomas Schnitzler2, Manfred Biselli2, Mario Becker1
1Sartorius Stedim Biotech GmbH, Gottingen, Germany, 2FH Aachen, Campus Julich, Julich
13 - 4
Using Monolithic Chromatographic Columns to Improve the Efficiency and Robustness of Biopharmaceutical Manufacturing Nika Lendero Krajnc, Lidija Urbas and Ales Strancar
BIA Separations, Slovenia
13 - 4
Automated Single use Mini-bioreactors: can they deliver scalable results and improve protein expression performance? Barney Zoro1, Kevin McHugh1, Amy Walde2, Alexis Bossie2
1TAP Biosystems - Sartorius, Royston, Herts, UK, 2Lonza, Walkersville, MD, USA
13 - 4
Online UPLC Applications for Biotherapeutic Development Douglas D. Richardson1, Zhi Chen1, Maria Khouzam2, Xiaodun Mou1, Daisy Richardson1, John Higgins2, and David Pollard1
1BioProcess Development, Merck Research Labs, Kenilworth, NJ, 2Process Analytical Technology, Merck Manufacturing Division
13 - 4
OPC-UA/ADI - A better way to provide System Device Integration Thomas Buijs
ABB, Quebec, Canada
13 - 4
A Dual-sensor Method for the Assessment of Minced Beef Microbial Quality A.I. Ropodi, D.E. Pavlidis, D. Loukas, P. Tsakanikas, E.Z. Panagou and G.-J.E. Nychas
Agrucultural University of Athens, Department of Food Science & Human Nutrition, Laboratory of Microbiology & Biotechnology of Foods, Athens, Greece
13 - 4
Towards the Automation of Food Quality/Contamination Assessment via Non Invasive Techniques Tsakanikas P., Panagou E. Z., Nychas G.-J. E.
Laboratory of Microbiology and Biotechnology of Foods, Department of Food Science & Human Nutrition, Agricultural University of Athens, Athens, Greece
13 - 5
IFPAC-2015 Special Issue Tuesday PM, January 27, 2015
13 - 5
An Efficient, Maintenance Free and Approved Method of Spectroscopic Control and Monitoring of Blend Uniformity: the moving F-test Rut Besseling1, Michiel Damen1, Thanh Tran2, Thanh Nguyen3, Kaspar van den Dries4, Wim Oostra5, Ad Gerich1
1InProcess-LSP, Oss, The Netherlands, 2Center for Mathematical Sciences, Merck/MSD, Oss, The Netherlands, 3InnoCore Pharmaceuticals, Groningen, The Netherlands, 4Patheon, Tilburg, The Netherlands, 5Abbott Healthcare Products, Weesp, The Netherlands
13 - 5
Product Quality beyond Compliance Case Study: Continuous Manufacturing Yanxi Tan Cain,Regional Head Novartis Pharma Quality Operation
Novartis, Basel, Switzerland
13 - 5
The Symbioses of the Control Strategy and the CPV Programme Line Lundsberg
Lundsberg Consulting, Ltd., UK
13 - 5
Linking "Regulatory Commitments" to Post Approval Changes Robert Iser, Senior Scientific Advisor (acting) Office of Process & Facilities
FDA/OPQ/CDER, Silver Spring, MD
13 - 5
Detecting and Responding to Unintended Variability Arne Zilian
Novartis, Basel, Switzerland
13 - 5
CpK<1.33, What Now? A Commercial Quality Perspective Paul Stojanovski
Teva Pharmaceuticals, Toronto, Canada
13 - 5
Using Process Capability to Enhance Product Quality Daniel Y. Peng, Ph.D., Senior Product Quality Reviewer Office of Process and Facility
OPF/OPQ/CDER/FDA, Silver Spring, MD
13 - 5
Continuous Bio-manufacturing - New Developments in Sensors and Automation Christian Grimm
Sartorius Stedim, Bohemia, NY
13 - 5
Optical Coherence Tomography Based Freeze Drying Microscopy (OCT-FDM) William Kessler1, Mircea Mujat1, Kristin Galbally-Kinney1, Vamis Mudhivarthi2, Michael Pikal2
1Physical Sciences, Inc., Andover, MA, 2Department of Pharmaceutical Sciences, School of Pharmacy University of Connecticut, Storrs, CT
13 - 5
A New Simple and Robust Process FT-NIR Spectrometer with Small Footprint and Extended Maintenance Interval Thomas Buijs and Michael B. Simpson
ABB, Quebec, Canada
13 - 5
Enhanced Raman Analyzer for Real Time Monitoring of Recycled Polymer Extrusion-An Integrated Approach from Development through Deployment Yusuf Bismilla1, Mark Kemper1, Richard Kramer2, Mike Power3, Edmir Silva4, Mike Doyle5
1Tornado Spectral Systems, Toronto, Canada, 2Applied Chemometrics, Inc., 3Symbion Systems, Inc., 4Unifi Manufacturing, Inc., 5Axiom Analytical
13 - 5
A Highly Reliable Sensor for Nickel Carbonyl and Iron Carbonyl in Ambient Air Thomas Buijs and Henry Buijs
ABB, Quebec, Canada
13 - 5
Novel Hydrogen Sensor for Applications in the Petrochemical and Power Industries Thomas Buijs and Michael B. Simpson
ABB, Quebec, Canada
13 - 5
Collaborative Development and Evaluation of a Liquid Chromatography Interface for Monitoring Process Development Ernest J. Hillier, Charles H. Phoebe, Aaron D. Phoebe and Thomas E. Wheat
Waters Corporation, Milford, MA
13 - 5
Considerations for Real-Time Liquid Chromatography Product Control within a Manufacturing Facility Hillary Hewitson, Charles H. Phoebe, Jr., Ernest J. Hillier and Aaron D. Phoebe
Waters Corporation, Milford, MA
13 - 5
Proposal for a Manufacturing Classification System (MCS) Kendal Pitt1, Michael Leane2, Gavin Reynolds3
1GSK, 2BMS, 3AZ
13 - 6
IFPAC-2015 Special Issue Wednesday AM, January 28, 2015
13 - 6
Lifecycle Management of Process Analytical Technology Procedures Marta Lichtig
Taro Pharmaceuticals, Haifa, Israel
13 - 6
Operational Opportunities in Continued Process Validation Tamar Ben-Avi
Taro Pharmaceuticals, Haifa, Israel
13 - 6
Excipient Quality Risk Management Reducing the Risk from the Variability of Raw Materials Brian Carlin
FMC BioPolymer, Ewing, NJ
13 - 6
Visualization of Study Data to Evaluate UDU Capability Thomas Parks, Jeff Hofer and Adam Rauk
Lilly
13 - 6
Reaction Monitoring with a Thermo Scientific picoSpin NMR Spectrometer John Frost
Thermo Fisher Scientific, Boulder, CO
13 - 6
A Case Study on the Possibilities of Industrial Internet in both PAT and Pharmaceutical Industry Pekka Teppola1, Pasi Hyttinen1, Sini Kivi1, Marko Kaarre1, Mikko Juuti1, Jukka Hast1, Simo-Pekka Simonaho2, Ossi Korhonen2, Jarkko Ketolainen2, Heikki Ailisto1
1VTT Technical Research Centre of Finland, Kuopio, Finland, 2University of Eastern Finland, Kuopio, Finland
13 - 6
COPA in Development and Research-Chemometrics Application in Biotherapeutics Development and Production Seongkyu Yoon
University of Massachusetts, Lowell, MA
13 - 6
Using POE with Tolerance Intervals to Define Design Space Patrick J. Whitcomb and Mark J. Anderson
Stat-Ease, Inc., Minneapolis, MN
13 - 6
Quality Assessments for an Organically-Complex Drug-Part 1: Background and the Chemometrics Role Peter Gibson
GW Pharmaceuticals, Cambridge, UK
13 - 6
Quality KPIs on the Shop Floor Chris Monchinski and Arlene Weichert
Automated Control Concepts Inc., Neptune, NJ
13 - 6
A Structured Investigation of Real-time Prediction of Milk Powder Functional Properties Brent R. Young1, Nick Depree1, Ira Boiarkina1, Taj Munir1, David Wilson2
1The University of Auckland, New Zealand, 2Auckland University of Technology, New Zealand
13 - 6
Potential of Hyperspectral Imaging for Quality Control in Milk Powders M.T. Munir1, Wei Yu1, David Wilson2, Brent R. Young1
1The University of Auckland, New Zealand, 2Auckland University of Technology, New Zealand
13 - 7
IFPAC-2015 Special Issue Wednesday PM, January 28, 2015
13 - 7
Implementation of a CPV Program and how Challenges are Addressed Arne Zilian
Novartis, Basel, Switzerland
13 - 8
IFPAC-2015 Special Issue Additional Presentations
13 - 8
Material Homogeneity During a Filling Operation: Retrospective Analysis of Historical Data, Process Validation and Routine Monitoring Kedar H. Dave, Brian Johnson, Joseph Shiminsky and Jeffrey Savard
Bristol-Myers Squibb, East Syracuse, NY


Volume/Issue
Title
Authors
14 - 1
AUTOMATED SIMULTANEOUS MONITORING OF THE CONVERSION AND ENANTIOMER EXCESS FOR THE ENANTIOMERIC KINETIC RESOLUTION OF EPICHLOROHYDRIN USING ON-LINE ACHIRAL HPLC WITH COUPLED UV AND POLARIMETRIC DETECTION Xuejun Xu, Nian Liu, Alice Yang, Thomas V. Raglione, and Yun K. Ye
Bristol-Myers Squibb Company, New Brunswick, NJ


Volume/Issue
Title
Authors
15 -
IFPAC-2016 Special Issue
15 - 1
IFPAC-2016 Special Issue Monday PM, January 25, 2016
15 - 1
IFPAC 2016 Co-Chair Introductions Jose C. Menezes1, Sau (Larry) Lee2, Sonja S. Sekulic3, Ernie Hillier,4
1IST, UTL, Lisbon, Portugal, 2FDA, CDER, OPQ,SS, Silver Spring, MD, 3Pfizer, Groton, CT, 4Waters Corporation, Milford, MA
15 - 1
The Future is Now A Pre-mortem on Breakthrough Medicines Jim Spavins
Pfizer, Groton, CT
15 - 1
Building Toward a Modern Pharmaceutical Manufacturing Sector: Encouraging Development and Adoption of Emerging Technology Sau (Larry) Lee
FDA/CDER/OPQ/SS, Silver Spring, MD
15 - 2
IFPAC-2016 Special Issue Tuesday AM, January 26, 2016
15 - 2
Quality Assessment: A Tapestry of Clinical Relevance, Quality by Design, and Regulatory Review Wendy I. Wilson-Lee
FDA/CDER/OPQ/ONDP, Silver Spring, MD
15 - 2
Predictability & Performance Through the Product Lifecycle Roger Nosal and Ravi Shanker
Pfizer, Groton, CT
15 - 2
Quality by Design, Clinical Relevance & Lifecycle Considerations Robert Iser
FDA/CDER/OPQ/OPF, Silver Spring, MD
15 - 2
Quality by Design and Clinical Relevance: Moving Forward -Clinical Pharmacology Considerations Mehul Mehta
FDA/CDER/OTS/OCP, Silver Spring, MD
15 - 2
Complexity in Pharmaceutical Systems Brian Carlin
FMC, Ewing, NJ
15 - 2
EMA's 2014 Regulatory Guidance on Near-Infrared Spectroscopy Line Lundsberg
Lundsberg Consulting Ltd, UK
15 - 2
Implementation of a Quantitative Mass Spectrometry Multi-Attribute Method (MAM) for Characterization, Quality Control Testing and Disposition of Biotherapeutics Richard Rogers
Just Biotherapeutics, Seattle, WA
15 - 2
Manufacturing Process Simulation: from Bioreactor to Shelf-Life using Bayesian Predictions Perceval Sondag1,2, Pierre Lebrun2
1Universite de Liege,2Arlenda, Flemington, NJ
15 - 2
To NeSSi or Not to NeSSi: A Fast and Micro GC Experience Review John Crandall
Falcon Analytical, Lewisburg, WV
15 - 3
IFPAC-2016 Special Issue Tuesday PM, January 26, 2016
15 - 3
The Choice of Sampling Frequency and Product Acceptance Criteria to Assure Content Uniformity for Continuous Manufacturing Processes Tim Kramer,Sal Garcia, Jeff Hofer, Xiaoyu Zhang, Ian Leavesley, Wyatt Roth, Leo Manley and Ahmad Almaya
Eli Lilly
15 - 3
QbD/PAT/RTRT Application and Regulatory Interaction in Japan Hiroshi Nakagawa
Daiichi Sankyo Co., Ltd., Japan
15 - 3
Use of Deep Learning for Contamination Detection on Glass Vials and Syringes Andre Villemaire1, Francois-Michel De Rainville1, Simon Levasseur1, Alexandre Vallieres1, Jean-Maxime Guay2
1NovaSyst, Quebec City, Qc, Canada, 2Pfizer Canada, St-Laurent, Qc, Canada
15 - 3
Use of FT-NIR Spectroscopy for Fast Quality Analysis of PET Packaging Material Thomas Buijs1, Simon Fischer2
1ABB, Qubec, Canada, 2Krones AG, Neutraubling, Germany
15 - 3
FDA Quality Oversight: One Quality Voice Lawrence Yu
FDA/CDER/OMPT/OPQ, Silver Spring, MD
15 - 3
Robust Optimization, Simulation, Scale Up and Effective Use of Design Space Thomas A. Little
Thomas A. Little Consulting, Highland, UT
15 - 3
PAT for Wet Granulation: Integrated Application of Mechanistic Understanding, In silico Modeling (DEM & PBM), and PAT Tools (FBRM & DFF/FT4) to inform Control Strategy and Construct In silico Design Space Ajit S. Narang1, Valery Sheverev2, Tim Freeman3, Douglas Both1, Vadim Stepaniuk2, Michael Delancy3, Doug Millington-Smith3, Tim Stevens1, Kevin Macias1, Rohit Ramachandran4, Brenda Remy1, Preetanshu Pandey1, Meg Escotet1, Dilbir Bindra1, Sherif Badawy1, Ganeshkumar Subramanian1, Atul Dubey5, Saprativ Basu5, Mothivel Mummadi5, David Boush6, Stephen Cole6, Richard LaRoche6
1Bristol-Myers Squibb, Co., New Brunswick, NJ, 2Lenterra, Inc., Newark, NJ, 3Freeman Technology, Tewkesbury, Gloucestershire, UK, 4Rutgers University, New Brunswick, NJ, 5Tridiagonal Solutions, Inc., San Antonio, TX, 6DEM Solutions, Denver, CO
15 - 3
Increasing Competitiveness of Legacy Stainless Steel Facilities in the Era of High Titer Processes and Single Use Technologies Rajesh Beri
Lonza Biologics, Portsmouth, NH
15 - 3
Particle Characterization Considerations for Complex Formulations Katherine Tyner
FDA/CDER/OPQ/ Science Staff, Silver Spring, MD
15 - 3
Screening and Development of Spray Dried Amorphous Solid Dispersions Marcio Temtem
Hovione FarmaCiencia sa, Loures, Portugal
15 - 3
Implementing Tunable Diode Laser (TDL) Technology for Process and Compliance Applications in the Power and PetroChemical Industries Tim Kuiken and Gary Cacciatore
Cemtek Environmental, Santa Ana, CA
15 - 3
From Fiber Spectrometers to Fiber Sensors for Process Control Igor Nazarov and Viacheslav Artyushenko
Art photonics, GmbH, Berlin, Germany
15 - 3
Using Online Mass Spectrometry for QbD Process Development Peter Traynor
Thermo Fisher Scientific, Scottsdale, AZ
15 - 3
Automating Development of Optimum Chromatographic Mobile Phase for Process Monitoring Amanda B. Dlugasch, Thomas E. Wheat, and Patricia R. McConville
Waters Corporation, Milford, MA
15 - 3
Automatic Combination of Orthogonal Separation Modes for Multiple Components in Mixtures Thomas E. Wheat, Amanda B. Dlugasch and Patricia R. McConville
Waters Corporation, Milford, MA
15 - 3
The Power of Heat and Multidimensional Separations in micro & Fast Gas Chromatography Robert Shellie1, John Crandall2
1University of Tasmania, Australia, 2Falcon Analytical, Lewisburg, WV
15 - 4
IFPAC-2016 Special Issue Wednesday AM, January 27, 2016
15 - 4
Non-routine uses of PAT Instruments Marta Lichtig
Taro Pharmaceutical Ltd., Haifa, Israel
15 - 4
Post (QbD) Approval: Why has my non-critical excipient gone critical? Brian Carlin
FMC, Ewing, NJ
15 - 4
Excipients Knowledge Management: Challenges & Solutions Ajaz S. Hussain
The National Institute of Pharmaceutical Technology & Education, Frederick, MD
15 - 4
Pharmaceutical Excipient Composition Chris Moreton
FinnBrit Consulting, Waltham, MA
15 - 4
Advancing mAb Process Development through Integration of DoE & MVDA with Mini Bioreactors and a Media Optimization Toolkit Barney Zoro1, Brian Lee2, Kevin McHugh2, Alexis Bossie3
1Sartorius, Royston, UK, 2Sartorius, Bohemia, NY, 3Lonza, Walkersville, MD
15 - 4
PAT in Pharmaceutical Process Optimization as support for QbD in Final Drug Product Manufacturing Pascal Chalus, Lene Maurer, Reto Maurer, Sigrid Pieters, Martin Betschart and Christian Lautz
F. Hoffmann-La Roche AG, PTDC, Basel, Switzerland
15 - 4
Real-time NIR Tablet Testing: Moving from At-line Sample-based to 100% Online Testing in Continuous Manufacturing Timo Schmidberger, Lorenz Liesum, Klaus-Peter Moll and Markus Krumme
Novartis AB, Basel, Switzerland
15 - 4
The Evolution of NIR Technology and Manufacturing Processes-Through Decades of NIR Deployments Charles Miller, Nathan Pixley, Bruce Thompson, Manoharan Ramasamy and John Higgins
Merck Sharp and Dohme, West Point, PA
15 - 4
QbD and PAT - The Uneasy Siblings in Highly Potent Drug Development Gert Thurau
F. Hoffmann-La Roche Ltd, Basel, Switzerland
15 - 4
Proven Acceptable Range (PAR) and Normal Operating Range (NOR) how to estimate and define in a complex multidimensional context Anna Persson and Conny Vikstrm
MKS Data Analytics Solutions
15 - 5
IFPAC-2016 Special Issue Wednesday PM, January 27, 2016
15 - 5
The State of Control for CPV - Red is the New Black Tara Scherder
Arlenda, Inc., Flemington, NJ
15 - 5
Implementing CPV in Smaller Organizations Line Lundsberg-Nielsen & Monica Hueg
NNE Pharmaplan
15 - 5
Product, Process Understanding and Statistical Process Control: PV Lifecycle Approach Naheed Sayeed, Ajay Pazayattil and Jana Spes
Apotex, Inc., Canada
15 - 5
Blender Modeling in a Continuous Direct Compaction Process using a Tanks in Series Method Shaun C. Galbraith, Seongkyu Yoon and Kevin J. Bittorf
University of Massachusetts Lowell, Lowell, MA
15 - 5
Leveraging Bayesian Statistics for Lifecycle Process Validation of Continuous Manufacturing Processes Tara Scherder1, Steven Novick1, Gilfredo Navarro2, Stan Altan2
1Arlenda, 2Janssen
15 - 5
Development of Novel Continuous Coating Machine Enabled Reliable Real Time Monitoring Takuya Nagato1, Kazuhiro Uchida1, Koji Hasegawa1, Hiroshi Nakagawa2, Kazuhisa Sekine2, Yuki Hasegawa2
1Powrex Corporation, 2Daiichi Sankyo Co., Ltd.
15 - 5
Findings from an IQ Consortium Survey: How far have we progressed in Analytical Quality by Design (AQbD)? Shreekant Karmarkar
Baxter Healthcare, Round Lake, IL
15 - 5
Molecular Isotopic Engineering (MIE): Industrial Manufacture of Naproxen of Predetermined Isotopic Compositions for Reasons of Authenticity, Security, and Intellectual Property Considerations J. P. Jasper1, P. Farina2, A. Pearson3, P. S. Mezes4, A. D. Sabatelli5
1Molecular Isotope Technologies LLC, 2Canaan Partners, 3Harvard University, 4Mezes Consulting, 5Dilworth IP, LLC
15 - 5
Lean QbD Risk Assessment - FDA Case Study on QbD for Modified Release Dosage Tablet Sun K. Kim
Siemens Healthcare
15 - 5
Comparison of Multi-Factor Screening Experimental Designs for Process Characterization Kadar H. Dave and Lily Tsang
Bristol Myers Squibb
15 - 5
Design and Deployment of Risk Management Tools to support QbD and Control Strategy Construction Bert Frohlich
Shire Pharmaceuticacls, Lexington, MA


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