Workshop
CMC Development for Biologics: Purification, Formulation, Analytical Characterization, Production Systems, Regulatory and Product Development
Speakers:
Judy Chou (Bayer); Michelle Frazier (Soigneur Regulatory Consulting); Rafi Mohammad (Bayer); David R. Dodds (Rondaxe); Shuang Chen (NGM Biopharmaceuticals); Guifeng Jiang (Boerhinger Ingelheim); Benson Gikanga (Genentech); Peter Soler (BMS)
Organizers:
Jim Zhang (Menlo Therapeutics), Rafi Mohammad (Bayer), Minli Xie (Myovant)
Date:
2019-05-06
Time:
8:45-17:00 Pacific Time
Registration fee:
(USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0
Location:
SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date:
(13)Absorption Systems; Analytical Lab Group; Applied StemCell; Aragen Bioscience; Charles River; Intertek; MabPlex USA, Inc.; MilliporeSigma [Sigma-Aldrich,Inc.]; MRIGlobal; Pacific BioLabs; PHC former Panasonic Healthcare; Pion Inc.; PPD
Registration: http://www.PBSS.org
Registration deadline:2019-05-01
(it will close sooner if the seating cap is reached)
About the Topic
Biologics today are widely used as targeted therapies and provide numerous advantages over conventional small molecule approaches. However, the processes and products are much less understood than their small molecule counterparts. Biologics medicines are manufactured via complex processes and have many potential sources of heterogeneity, often impacting function.
This workshop provides an overview of CMC (Chemistry, Manufacturing and Controls) development of biologicals, including the technologies of biological production via cell culture and fermentation, purification processing, drug product and packaging and analytical control systems. The lifecycle of development from product definition, preclinical, clinical and commercial stages will be covered. Approaches and challenges for processing and analytical development will be addressed. Case studies will be discussed to illustrate approaches to develop successful manufacturing processes and effective analytical control strategies.
This workshop will benefit scientists, analysts and BD associates, research associates, managers, directors, regulatory affairs, quality control, quality assurance, and device and process engineers currently working in the pharmaceutical and biotechnology industry who want to improve their understanding of the best practices in CMC development of biologicals. This workshop is also useful for non-pharma scientists who seek better technical understanding of processes, challenges and opportunities in the industry.
The following key topics will be discussed.
- Purification process of biologics
- Biologics drug product development including formulation and device development, compatibility and automation
- Analytical characterization of biologics
- Regulatory aspects of biologics development
- Production systems of biologics
Workshop Agenda
8:45-8:55 Welcome and overview - Shichang Miao, Jim Zhang, Rafi Mohammad
8:55-9:40 1. Overall CMC strategy - Judy Chou
9:40-10:25 2. Regulatory process - Michelle Frazier
10:25-10:35 Major Sponsor Presentation - Abzena
10:35-10:55 Break & Vendor Show
10:55-11:40 3. Biological Drug Product Compatibility - Rafi Mohammad
11:40-12:25 4. Production system - David R. Dodds
12:25-13:25 Lunch
13:25-14:10 5. Down Stream Processing: Principles, Development, and Implementation of Manufacturing Processes - Shuang Chen
14:10-14:55 6. Analytical Characterization for Monoclonal Antibody - Guifeng Jiang
14:55-15:05 Major Sponsor Presentation - Waters
15:05-15:25 Break & Vendor Show
15:25-16:10 7. Process Development : Impact of Processing Equipment Design on Product Quality of Biologics: A case Study - Benson Gikanga
16:10-16:55 8. Formulation Development: Leveraging the Laboratory Automation and High-Throughput Screening - Peter Soler
16:55-17:25 Panel Discussion
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