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Workshop

CMC Development for Biologics: Purification, Formulation, Analytical Characterization, Production Systems, Regulatory and Product Development


Speakers:
Organizers:
Date: 5/6/2019
Time: 8:45-17:00
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: (1)Abzena;(Major Sponsorship - afternoon session still open)
Vendor show vendors registered to date: (4)Analytical Lab Group; MilliporeSigma; PHC former Panasonic Healthcare; PPD
Registration: http://www.PBSS.org
Registration deadline:5/6/2019  (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

 


2019-03-07, Promising Therapeutic Approaches and Translational Medicine to Advance Novel Therapeutics (A Joint Symposium by PBSS and Stanford SPARK Program)
2019-03-11, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
2019-04-25, Tox 21 and New Approach Methodology (NAMs): Using Emerging Technologies to Improve Translational Research and Safety Assessment Predictions (jointly by SOT-NorCal & PBSS)
2019-06-11, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
2019-09-13, Biotransformation and Disposition of Larger Molecules: Peptides, Nucleotides, Proteins, mAbs, and ADCs
2019-10-03, Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends
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