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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: (2)Abzena; Waters Corp.
Vendor show vendors registered to date: (13)Absorption Systems; Analytical Lab Group; Applied StemCell; Aragen Bioscience; Charles River; Intertek; MabPlex USA, Inc.; MilliporeSigma; MRIGlobal; Pacific BioLabs; PHC former Panasonic Healthcare; Pion Inc.; PPD
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

2019-09-13, Biotransformation and Disposition of Larger Molecules: Peptides, Nucleotides, Proteins, mAbs, and ADCs
2019-10-03, Small-Molecule Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends
2019-10-18, Physiologically Based Pharmacokinetic (PBPK) Modeling: Fundamentals, Regulatory Guidance & Applications
2019-11-12, Antibody Drug Discovery and Development: Hit Generation, Engineering, Cell-line Development, IND enabling studies, and Biosimilars
2019-12-10, In Vitro Diagnostics, Companion Diagnostics and Precision Medicine
2020-01-21, Best Practices for Clinical Trial Design
2020-02-11, Drug-Device Combination
2020-02-24, Advanced LC-MS/MS (Day1) & Interpretation of MS/MS CID Spectra (Day2)
2020-05-12, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-05-22, No More Undruggables: Unconventional Approaches for Drug Discovery and Design - prodrugs, PROTACS, fragment-based design, directed evolution and beyond
2020-06-23, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
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