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October 8-12, 2012
Rhode Island Convention Center
Providence, Rhode Island
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Analytical Technologies for Biopharmaceutical Development
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:00
Registration and Coffee
Analytical Technologies for Biopharmaceutical Development
8:00
Chairperson's Remarks
Jon Kauffman, Ph.D., Director, Method Development & Validation, Biochemistry, Lancaster Laboratories
Jon Kauffman, Ph.D., Director, Method Development & Validation, Biochemistry, Lancaster Laboratories
Unpublished Data
8:15
Case
Study
Technology Improvements to Accelerate Process Development of BiologicsStudy
The presentation will show how innovation through automation and single-use technology has led to more efficient process development. This includes the creation of multi use tools to handle both cell culture and microbial expression platforms. Improvements will be shown for end to end development focusing on upstream processing followed by purification and analytics. A novel small scale single use prototype bioreactor is evaluated.
Rachel Bareither, Biochemical Engineer, Bioprocess Development, Merck & Co Inc.
Unpublished Data
8:45
Case
Study
Study
BaychroMAT Bioplatform as an Analytical Key for Quality by Design
Currently FDA and other regulatory agencies encouraging pharmaceutical industry to a paradigm change and the use of process analytical technologies (PAT) in pharmaceutical production. This will lead to „Quality by Design"-processes, where important parameters will be measured and controlled online. Thus innovative online analytics for process control is one of the new PAT tools and will be a key enabler for improved pharmaceutical manufacturing. BaychroMAT is a platform that fully automates analyzers. Additional automation components enable high operational availability. The BaychroMAT Bioplatform includes an innovative sterile sampling device, an automated sample transport, an integrated sample preparation module, online analyzers and communication interfaces to process automation systems via OPC. This is established for stainless steel bioreactors in Pilot Plants. We will present our expanded platform for Process Development. Latest data will be presented as well as our setup of a closed-loop control for glucose including an integrated PAT data management.
Stefan Steigmiller, Ph.D., Head of PAT-Biotechnology Projects, Bayer Technology Services GmbH, Germany
Currently FDA and other regulatory agencies encouraging pharmaceutical industry to a paradigm change and the use of process analytical technologies (PAT) in pharmaceutical production. This will lead to „Quality by Design"-processes, where important parameters will be measured and controlled online. Thus innovative online analytics for process control is one of the new PAT tools and will be a key enabler for improved pharmaceutical manufacturing. BaychroMAT is a platform that fully automates analyzers. Additional automation components enable high operational availability. The BaychroMAT Bioplatform includes an innovative sterile sampling device, an automated sample transport, an integrated sample preparation module, online analyzers and communication interfaces to process automation systems via OPC. This is established for stainless steel bioreactors in Pilot Plants. We will present our expanded platform for Process Development. Latest data will be presented as well as our setup of a closed-loop control for glucose including an integrated PAT data management.
Stefan Steigmiller, Ph.D., Head of PAT-Biotechnology Projects, Bayer Technology Services GmbH, Germany
9:15
Application of QbD Concepts in Analytical Method Development
Analytical method operating parameters have traditionally been evaluated One-Factor-at-a-time (OFAAT) during method development with minimal considerations for variable interactions. In addition, demonstration of analytical method robustness is typically performed after completion of method development to support method validation per ICH guidance. Therefore if method performance parameters fail robustness the method often has to be re-developed. This serial approach in the life cycle of analytical method development contains inherent risk and could be potentially costly. With Quality-by-Design (QbD) based experimental approach, variable interactions are detected during method screening and optimization, and method robustness is evaluated during method development. QbD designed and tested robust analytical methods can be developed efficiently with knowledge of the method's operating space. Examples of HPLC analytical method robustness testing and HPLC analytical method development using an integrated QbD software (Fusion AE from S-Matrix) are presented and discussed.
Anna Ip, Senior Asocciate Scientist, Amgen Inc.
Analytical method operating parameters have traditionally been evaluated One-Factor-at-a-time (OFAAT) during method development with minimal considerations for variable interactions. In addition, demonstration of analytical method robustness is typically performed after completion of method development to support method validation per ICH guidance. Therefore if method performance parameters fail robustness the method often has to be re-developed. This serial approach in the life cycle of analytical method development contains inherent risk and could be potentially costly. With Quality-by-Design (QbD) based experimental approach, variable interactions are detected during method screening and optimization, and method robustness is evaluated during method development. QbD designed and tested robust analytical methods can be developed efficiently with knowledge of the method's operating space. Examples of HPLC analytical method robustness testing and HPLC analytical method development using an integrated QbD software (Fusion AE from S-Matrix) are presented and discussed.
Anna Ip, Senior Asocciate Scientist, Amgen Inc.
9:45
Networking Refreshment Break
Unpublished Data
10:15
Case
Study
Analytical Challenges in Cleaning Validation Programs for Potent BiopharmaceuticalsStudy
Multi-product biologics manufacturing facilities rely heavily upon Total Organic Carbon (TOC) measurements to confirm adequate product clearance. Whilst TOC serves as a useful non specific technique, its use is limited for potent biological molecules. Laboratory based protein degradation studies (sampling / soils / controls and spiking) are discussed together with techniques that would have the potential to augment TOC data.
Rebecca Hill, Ph.D., Staff Scientist, Analytical Development, FUJIFILM Diosynth Biotechnologies UK Ltd, United Kingdom
Unpublished Data
10:45
Case
Study
Analytical Strategies for Monitoring Impurities Encountered in BioprocessingStudy
Regulatory agencies, including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are responsible for the safety and efficacy of pharmaceutical products administered to patients and therefore are scrutinizing impurities in biopharmaceutical products. While some impurities are related to the drug product, others are introduced during bioprocessing. Leachables are compounds that leach into the drug product formulation from disposables utilized in bioprocessing as a result of direct contact with the formulation. They must be controlled so that drug products are not adulterated. Residuals are another class of impurities that are introduced during bioprocessing. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays and ongoing testing can be quite challenging. Further, biomanufacturing is a complex process involving many steps. Thus the sample matrix types can vary greatly due to the fact that sampling at a variety of process steps is required to accurately monitor the impurity throughout the production process. This presentation will discuss these challenges, and the strategies utilized to overcome them through case study examples.
Jon Kauffman, Ph.D., Director, Method Development & Validation, Biochemistry, Lancaster Laboratories
Unpublished Data
11:15
Case
Study
Analytical Characterization of Next Generation Antibody Drug ConjugatesStudy
Analytical characterization of proteins involves the application of complementary methods that take advantage of independent physical, chemical properties of these complex biomolecules. An additional layer of complexity is added with characterization of Antibody-drug conjugates (ADCs) dependent not only on the types of conjugation chemistry used, but also on properties, number, and attachment sites of the cytotoxic drug-linker. The ability to site-specifically attach toxins can substantially reduce the complexity allowing the conjugate to be identified, characterized, and impurity profiles to be accurately assessed, which in turn is required for the understanding and selection of molecules with optimal attributes.
Anna-Maria A. Hays Putnam, Ph.D., Group Leader, Analytical & Formulation Development, Ambrx, Inc.
Luncheon Presentation (Space is limited)
12:15
Speaker TBD
3:15
Grand Opening of Poster and Exhibit Hall with Refreshments
Keynote Presentations
Chairperson: Howard L. Levine, Ph.D., President, BioProcess Technology Consultants, Inc.
4:00
Overview of Approval Pathway under Biologics Price Competition and Innovation Act of 2009Dr. Kozlowski will give an update on the new biosimilars statute.
Steven Kozlowski, M.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA
4:35
EMA Draft Guideline on Biosimilar Monoclonal AntibodiesEU has been the pioneer in creating the regulatory framework for the development of biosimilar drugs. The overarching "Guideline on Similar Biological Medicinal Products" came into force in 2005, and the guidelines describing non-clinical & clinical and quality aspects of the development were available in 2006. In addition, there are a number of adopted product specific guidelines (e.g on erythropoetins, insulin, interferon alpha). Since then already 14 biosimilar products have been approved by the European Medicines Agency (EMA). Currently the Working Party on Biosimilar Medicinal Products (BMWP) is drafting a guideline on biosimilar monoclonal antibodies.
Esa Heinonen, M.D., Ph.D., Member of the EMA Working Group on Biosimilars, Head of Section 2, Marketing Authorizations, Finnish Medicines Agency (Fimea), Finland
5:10
Ready or not Biosimilars are Coming to U.S.Biosimilars have already become a common practice within the EU with a significant number of launches over the last five years. A wave of biosimilar products are expected to be submitted to the USFDA as the guidance are drafted and adopted. Technical, clinical, and manufacturing challenges will need to be overcome to allow satisfactory licensure of these products and open these markets to competition. This is expected to aid in reduced cost and improved patient access.
Jay S. Stout, Ph.D., Executive Director, Biologics Manufacturing Sciences and Commercialization, Merck & Co., Inc.
5:45
Networking Reception in Poster & Exhibit Hall
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