Day 1 | Day 2
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Tuesday, March 20, 5:00 – 6:00 PM
About this conference:
Following previous successes, CHI’s third Comparability conference will continue to bring together teams within biotech responsible for ensuring consistent product quality and smooth interaction with the regulatory authorities. The event features comparability case studies for a wide range of therapeutic proteins. The impact of process change on the product will be investigated and proposals made for when to make a change and how to avoid extensive comparability studies. There will be a strong emphasis on providing suitable comparability data to the regulatory authorities to reduce difficulties and delays, and to ensure safety and efficacy with every batch. Industry and regulatory perspectives will be presented with time allowed for questions, and panel and group discussions.
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Pre-Conference Welcome Reception in the Exhibit Hall with Poster Viewing
Wednesday, March 21
8:00 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
Reed J. Harris, Senior Director, Protein Analytical Chemistry, Genentech, Inc. (a member of the Roche Group)
8:35 Speaker to be Announced
9:05 Industry Perspectives on Expectations Regarding Impurities
Andrew Chang, Ph.D., Executive Director, Global Regulatory Affairs, Novo Nordisk, Inc. - Biography
9:35 Regulatory Expectations Regarding Aggregates and Comparability
Ewa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, Division of Hematology, CBER, FDA - Biography
Quantitation and characterization of protein aggregates in biologics is important to ensure quality and safety of the products, consistency of manufacture between lots and comparability when the manufacturing process is being changed. Characterization of the aggregates’ full size range still presents a challenge and safety information is still limited. Challenges and advances in the field will be discussed.
10:05 Sponsored Presentation (Opportunity available, please contact Jon Stroup, jstroup@healthtech.com)
10:25 Networking Coffee Break in the Exhibit Hall with Poster Viewing
11:00 Application of Biophysical Techniques in Comparability Exercises: Quantitative Assessment of Spectral Similarity
Qin Zou, Ph.D., Senior Principal Scientist, BioProcess Analytics, Pfizer, Inc. - Biography
Biophysical tools, including circular dichroism spectroscopy, have been used to provide qualitative assessment of the similarity in higher order structure for biological molecules through visual inspection of the characteristic spectral overlay. This presentation will focus on providing more quantitative evaluation of spectral similarity using statistical analysis.
11:30 Introducing New Methodologies for Comparability Studies
Stacey Traviglia, Ph.D., Associate Director, Analytical Technology, Biogen Idec, Inc. - Biography
Improving analytical methods during the lifecycle of a program is not an exception, it’s the rule. The challenges that exist when introducing a new methodology are amplified when it coincides with manufacturing changes. Method comparability, cross-over studies, and a strategy for comparability will be presented as a case study.
12:00 pm Analyses of N-Glycosylation Patterns for Comparability Assessment of Biotherapeutic Proteins
Tanya Q. Shang, Ph.D., Principal Scientist, Analytical R&D, Pfizer, Inc. - Biography
A case study is presented where a small change in N-linked glycan distribution was detected after a process change. The assessment of the significance of this change included evaluation of orthogonal analytical results, previous in vitro and in vivo data on the role of N-glycosylation, and historic data based on manufacturing experience.
12:30 Innovating Purity and Heterogeneity Analysis: Application of Capillary Electrophoresis for Characterization of Biotherapeutics
Mark Lies, Ph.D., Marketing Manager, Beckman Coulter Inc.
Capillary electrophoresis (CE) has taken on a leading role in characterizing biotherapeutics. A brief discussion on key applications of CE technology as it pertains to the biopharmaceutical industry will be provided. Solutions for protein purity analysis, charge heterogeneity determination, and glycan anlaysis will be presented.
12:45 Luncheon Presentation (Opportunity available, please contact Jon Stroup, jstroup@healthtech.com) or Lunch on Your Own
2:00 Chairperson’s Remarks
Andrew Chang, Ph.D., Executive Director, Global Regulatory Affairs, Novo Nordisk, Inc.
2:05 Comparability of a Monoclonal Antibody across Cell Lines and Across the Pond
Mark A. Bowe, Ph.D., Director, Quality Control, MacroGenics, Inc. - Biography
Due to changing from NS/0 to a CHO cell line and an improved manufacturing process, extensive comparability was conducted prior to Phase II/III. PK and functional biological assays complemented biochemical studies to establish comparability. During phase III, manufacture of the product was moved to the EU, necessitating additional comparability studies.
2:35 Evaluation of Comparability due to Changes in Scale-up, Process, Manufacturing Site, and Formulation
Soundara Soundararajan, Ph.D., Principal Scientist, Bioprocess Development, Merck & Co., Inc. - Biography
A preliminary comparability study to evaluate the changes due to scale-up, manufacturing site, process and formulation of batches used in phases I/II and III was performed. The release and extended characterization results from this study are presented. Preliminary assessment of comparability studies as presented will help to establish the type of analytical testing required to correlate manufacturing changes to the product characteristics in the final comparability testing.
3:05: Speed Networking
3:35 Networking Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Implementing Advanced Analytical Methods: Regulatory-Approved Comparability Strategies and Case Studies
Stephan O. Krause, Ph.D., PDA Task Force Leader for Analytical Methods, and Principal Scientist, Analytical Biochemistry, MedImmune, Inc. - Biography
Analytical method comparability/replacement studies apply when test methods are changed during the product life cycle. A non-inferior, equivalent, or superior replacement study model can be selected based on the intended use of the new test method. Risk-based acceptance criteria should be set from product specifications and existing manufacturing process knowledge. Case studies will be used to illustrate the strategies for each test method type.
Featured Presentation
4:30 Risk Analysis Tools Used to Define a Control System for a Quality by Design Product
 Reed J. Harris, Senior Director, Paul A. Motchnik, Ph.D., and Mary M. Cromwell, Ph.D., Associate Directors, Protein Analytical Chemistry, Genentech, Inc. (a member of the Roche Group) - Biography
Quality by Design products will have control systems designed to control patient impacts instead of simply demonstrating consistency. Our QbD specifications strategy employs risk analysis tools that enable us to define an appropriate control system using a systematic approach. The challenges of applying these tools systematically, and some key health authority negotiation issues, will be discussed.
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5:00 Breakout Discussions
Table 1: Regulatory Expectations regarding Aggregates and Comparability
Moderator: Ewa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, Division of Hematology, CBER, FDA - Biography
• Potential impact of impurities on safety and efficacy
• What are the expectations regarding impurities?
• Risk management
Table 2: Development of a Manufacturing Strategy to Minimize the Need for Comparability Studies
Moderator: Andrew Chang, Ph.D., Executive Director, Global Regulatory Affairs, Novo Nordisk, Inc. - Biography
• How to develop a product to ensure future process lifecycle evolution
• Extent of product/process understanding required
• Manufacturing strategies
Table 3: Comparability Using More Advanced Characterization Methodologies than the Original Application
Moderator: Stacey Traviglia, Ph.D., Senior Scientist, Analytical Technology, Biogen Idec, Inc. - Biography
• Regulatory concerns driving advancements in characterization during comparability
• New tools/technologies for advanced characterization
• Methods for assessing comparability in the absence of historical data
Table 4: Implementation of Quality by Design
Moderator: Reed J. Harris, Senior Director, Protein Analytical Chemistry, Genentech, Inc. (a member of the Roche Group) - Biography
• Identifying CQAs and acceptable CQA ranges
• Determination of process, formulation, and/or specification control of CQAs
• Identification of upstream and downstream process CPPs
• QbD implementation challenges
Table 5: Formulation and Stability for the Product throughout Development
 Moderators: Ruth Cordoba-Rodriguez, Ph.D., Division of Monoclonal Antibodies, Office of Biotechnology Products, CDER, FDA and Y. John Wang, Ph.D., FAAPS, Principal Scientist, Late Stage Pharmaceutical Development, Genentech (a member of the Roche Group) - Biography
• Prediction of sites on the molecule that may affect stability and potency
• Formulation studies data submitted with a license application
• Testing required when changing drug format (e.g., from vial to prefilled syringe)
• How stability requirements vary with stage and nature of the drug
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6:00 End of Day One of Comparability for Change Implementation
Day 1 | Day 2
Download Biotherapeutics Analytical Summit Brochure or Download This Track Brochure