IFPAC 2012 Conference Preview

The 26th International Forum and Exhibition Process Analytical Technology (Process Analysis and Control) (IFPAC) conference will be held January 22–25, 2012 at the Baltimore Marriott Waterfront (Baltimore, Maryland). For more than 25 years, the conference has discussed trends in technology, standards, and controls with industry, academic, and government experts. IFPAC attendees come to learn more about how they can boost productivity, streamline implementation processes, enhance operational efficiency, and maximize their resources. Just like past years’ events, this year’s conference will bring in speakers from various regulatory agencies and associations, such as the National Institute of Standards and Technology (NIST), the National Institute for Pharmaceutical Technology and Education (NIPTE), and the Center for Process Analysis and Control (CPAC), as well as from leading universities such as Massachusetts Institute of Technology (MIT), Duquesne, Rutgers, and the University of Washington; and from chemical, petrochemical, biotechnology, and pharmaceutical corporations.

Opening Plenary Features FDA’s Janet Woodcock and Quality by Design

Leading off this year’s plenary session will start with Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). The session will also feature an update on quality by design (QbD) and process analytical technology (PAT) from the European Medicines Agency; a presentation from the senior vice president of global science technology and commercialization of Merck’s Manufacturing Division (Whitehouse Station, New Jersey); a presentation from the director of marketing for environmental and industrial segments (instruments) at PerkinElmer (Waltham, Massachusetts); and more.

Program Overview

IFPAC-2012 will feature comprehensive pharmaceutical and biotechnology tracks, including the following topics: pharmaceutical product performance, process control, sampling, real-time release, continuous manufacturing, risk management, bioprocessing, bioreactors, PAT applied for biologics manufacturing, life-cycle management of analyzer and method reliability, imaging, particle characterization, screening, and surveillance. Various analytical techniques also will be covered including: near infrared (NIR) spectroscopy, Raman spectroscopy, mass spectroscopy, and laser-induced fluorescence. In addition, there will be involvement by the International Consortium for Innovation and Quality in Pharmaceutical Development.

Other topics include: the latest information on advanced instrumental concepts for process analysis, new sensor technology, manufacturing — improved measurements in the control scheme, control strategies, process Raman spectroscopy, process communications, particle characterization and analysis — ultrasound spectroscopy, and data management.

IFPAC also is offering a preconference workshop titled “Implementation of Quality Systems — (Emphasizing NIR)” on Sunday afternoon, January 22nd.

Program Highlights

Several sessions related to instrumentation, techniques, case studies, and data management will be at IFPAC-2012. Following the Plenary session on Monday morning, attendees will have several sessions to choose from:

• Monday Afternoon – Advanced Instrument Concepts, Risk Management, Raman, and more

• Tuesday Morning – Advanced Separations, Chemometrics I, Chemical Imaging, QbD, BioReactors, Control Strategies for Drug Development and Manufacturing, and more

• Tuesday Afternoon – Chemometrics II, Advanced Separations/Mass Spec, Process Control, Imaging II, PAT Applied for Biologics Manufacturing, PAT Approaches to Continuous Manufacturing, and more

• Wednesday Morning - Screening & Surveillance/Handheld Instrumentation, Particle Characterization, Tools & Case Studies for Process Understanding and Control, Life Cycle Management and Analyzer Reliability, Continuous Manufacturing, BioProcessing, and more

• Wednesday Afternoon – Process Communications, Process Analysis/Spectroscopy, Real-Time Light Induced Fluorescence (LIF), Bridging the Quality Gap between Benchtop and Field Instruments, Role of Excipients in QbD, and more

• Advanced Instrument Concepts — Presentations include: “New Developments in Probes and Systems for High Sensitivity Molecular Spectroscopy” (Axiom Analytical, Inc.); “New Mid-IR Interferometer Technology GC Technology” (DuPont Siemens Industry, Inc.); "A Real-time, Portable Instrument and Platform Which is Able to Identify and Quantify Trace Concentrations of Solvents, Contaminants in Raw Materials, CIP Residues and Adulterants in Packaging Materials Right at the Point of Need: Field Asymmetric Ion Mobility Spectrometry (FAIMS) by Owlstone” (Global Partnership GM); “Advanced LIBS Analysis” by Photon Machines; “New Opportunities in Trace-Gas Sensing Using Differential Optical Dispersion Spectroscopy (DODiS)” (Electrical Engineering Department of Princeton University); and presentations from ART Photonics and the University of South Carolina.

• Advanced Separations — Presentations include: “Practical Considerations for High-Throughput LC Methods and equipment in Process Analytical Development and Production Applications” (Thermo Fisher Scientific); “Ultra Performance Liquid Chromatography (UPLC)” (Waters Corp.); “Volatile Chemical Waste Component Measurements in Marine Fuel (bunker) Oil Using a Novel Micro-Channel Active Splitting Wafer Device and GC–MS” (PerkinElmer Inc.), and more.

• Mass Spectrometry — Presentations include: “Inline Monitoring of Reactions and Processes in Real-Time Using a Miniature, Chip-based Mass Spectrometer” (Microsaic Systems); “Quadrupole Mass Spectrometers coupled with Membrane Technology Allow for PPT Detection Levels in Difficult Ambient Air Applications” (Extrel CMS LLC); “Use of Quadrupole Mass Spectrometers for Flue Gas Analysis in Fluidized Catalytic Cracking Units (FCCU)” (AMETEK Process Instruments); and more.

• Chemometrics — Presentations include: “18 Fuel Properties Determined in 3 Minutes by Raman Spectroscopy” (Real-Time Analyzers, Inc.); “Bayesian Inference based Two-stage Support Vector Regression Method for Soft Sensor Development of Batch Processes” (McMaster University); “Surrounding and Solving an Analytical Problem with Data Fusion” (Applied Physics Laboratory - University of Washington); “Process Analytical Technologies and Smart Chemometrics in Rapid Scale Up” (Newcastle University, School of Chemical Engineering and Advanced Materials); “A Robust Computational Approach for Recognition and Quantification of Biomarkers Using Multi-dimensional Data Streams” (National Institute of Standard); “Effect of Blend End-point Algorithms on Blend Homogeneity” (Duquesne University); “Use of Spatial Distance and Clustering Methods for In-line Diagnostic of Outlier Detection” (University of Puerto Rico – Mayaguez); and presentations from Process NMR Associates, Dow Chemical, Eigenvector Research, Inc., Photon Machines, Umetrics; and “30 Years of Chemometrics” with Fred Fry and Sara Handy, FDA, CFSAN.

Sampling Evening Discussion

Large Sample Sizes for Batch Release Decisions — Tuesday Evening Session — Sonja Sekulic, Pfizer, Karthik Lyer, FDA and Gert Thurau, Merck

Advances in technology related to in-line/on-line and at-line sampling of pharmaceutical products are now allowing for a much larger number of units or portions of a batch to be analyzed. While this is desirable for increased process understanding and monitoring the availability of a much larger set of results has, for example in the area of content uniformity of tablets, lead to potential conflicts with more traditional specifications which use sampling approaches based on a fairly small number of samples (10–30) for assessing uniformity. With several Real-time release testing approaches approved in the last couple of years that include non-traditional specifications including the use of "operational curves" and non-zero tolerance criteria for uniformity the need for harmonization of approaches has become more pressing to avoid uncertainty for all stake holders and a potential regressing from the use appropriate sample sizes. Since the topic is crossing statistical as well as practical PAT application science boundaries both in industry, academia and regulatory agencies there is a strong desire for cross-functional collaboration. This evening workshop will discuss findings at a recent PQRI workshop on this topic and allow for an ongoing conversation among IFPAC PAT practitioners and regulators.

Poster Sessions

These sessions offer an excellent opportunity for one-on-one discussions and networking.

With more than 20 topics covering all industry segments, IFPAC provides an opportunity to interact with industries that have been using process analysis and control for nearly 60 years.

IFPAC-2012 Exhibition

Monday, January 23: 2:00–7:00 p.m.

Grand Opening: 2:00 p.m.

Tuesday, January 24: 10:00 a.m.–4:00 p.m.

Wednesday, January 25: 9:00 a.m.—12:00 p.m.

Exhibitors at this year’s event include:

• ABB Analytical Measurement

• Agilent Technologies

• American Pharmaceutical Review

• Applied Instrument Technologies (AIT)

• Automation.com

• ASTM

• BaySpec, Inc.

• BioPharm International

• BUCHI Corporation

• Canty

• CDS Analytical

• CIRCOR Technologies

• COBALT Light Systems

• CPAC, Center for Process Analytical Chemistry

• CPACT

• DASGIP Biotools

• Duquesne University/SPCTECH

• DURASENS

• Eisai Machinery, U.S.A., Inc.

• Emerson Process Management/Rosemount Analytical

• Enwave Optronics, Inc.

• European Pharmaceutical Review

• Extrel CMS

• 4TUNE Engineering, Ltd.

• FOSS NIRSystems, Inc.

• FTRX LLC

• Hamilton Company

• IFPAC

• ISPE

• Kaiser Optical Systems, Inc.

• LCGC North America

• Nova Biomedical

• Pharmaceutical Manufacturing

• PharmaQbD.com

• Real-Time Analyzers, Inc.

• Rimbach

• Rosemount Analytical

• RURO, Inc.

• Siemens Industry, Inc.

• Spectroscopy

• StatSoft, Inc.

• Stratophase, Ltd.

• Swagelok Co., LLC.

• Thermo Scientific

• Thermo Scientific-Scientific Instruments

• Uhlmann VisioTech GmbH

• Umetrics

• Waters Corporation

It's an opportunity to see and be seen by old and new colleagues and customers. Any companies interested in exhibiting at IFPAC-2012 are invited to contact conference management as soon as possible.

Registration Information

This event is being held January 22–25, 2012 at the Baltimore Marriott Waterfront Hotel, located within Baltimore's Inner Harbor.

Local and all-inclusive registration is available at the conference website: www.ifpacpat.org.

For more information contact: (847) 543-6800; info@ifpacnet.org; or visit www.ifpacpat.org.