Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges

Stay on top of the chemistry, manufacturing and controls (CMC) regulatory requirements in the US, Europe and other highly regulated regions.

In-person Biologics CMC Workshop

19–20 September 2018
US Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, MD 20852
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STAY INFORMED


A lot goes into biopharmaceutical CMC development and preparation of dossiers in biologic product development
and registration.

Master the process with RAPS in-person workshop led by CMC experts. 

In two days, gain an understanding of biological product characteristics; CMC regulations and guidance applicable to biologics; Quality by Design, adventitious agents risk management; source material, cell and seed banks; upstream and downstream processing, formulation and final product production; characterization and testing; and demonstrating comparability.

Objectives:

  • Be familiar with various types of biologic products and their structural/functional characteristics
  • Understand development phase-appropriate Regulatory Agency expectations associated with biologics and biosimilars characterization, development, production and testing
  • Understand best practices in establishing a comprehensive Chemistry, Manufacturing, and Control (CMC) regulatory strategy for application to the lifecycle of biologic and biosimilar products
  • Understand Quality by Design principles as they relate to development, manufacturing, characterizations, and testing of biologic products

Who Should Attend:

These workshops are beneficial for professionals working in the drugs, biologics or combination products fields who are involved in CMC development, registration and post approval lifecyle management for biologic/biosimilar products.. There are no prerequisites and you do not have to be a RAPS Member to participate.

19–20 September 2018
US Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, MD 20852
Day One: 19 September
  • Types of biologic products (therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene therapies, cell-based therapies)
  • Biologics/biosimilars product characteristics and corresponding regulatory implications
  • Biologics/biosimilars CMC regulation and guidance framework
  • Clinical phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars

Day Two: 20 September
  • Clinical phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars (continued)
  • Downstream processing
  • Final product formulation
  • Characterization
​Training participants can receive 12 RAC Credits.

  STAY INFORMED


Faculty

Patricia Cash, PhD, Independent Biotechnology Consultant, LLC
Joseph Quinn, biologics regulatory consultant