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

17-18 April 2019
The Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20850
Register Now


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.

Faculty


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Patricia Cash, PhD, independent biotechnology consultant, LLC

Dr. Patricia W. Cash, Ph.D. is a senior leader with over 25 years experience in all aspects of analytical development, specification setting, quality control testing and preparing and defending regulatory filings. She is currently an independent consultant. She previously was senior director in the Analytical Biochemistry Department at MedImmune, where her group was responsible for developing and implementing analytical methods used for characterization, lot release, and in-process testing of all protein projects at various stages of development. She holds a Doctorate of Philosophy and a Masters of Science degree in Chemistry from Rutgers University, Bachelor of Arts degree in Chemistry from The King’s College, and a Masters of Business Administration, Technology Management from University of Phoenix.


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Joseph Quinn, biologics regulatory consultant  

Joe Quinn is an independent Regulatory Affairs Consultant with 33 years experience in the biologics/vaccine industry, including assignments in quality control, research, product development & scale-up, bioanalytical development & validation, project management, and regulatory affairs. Joe was employed by Sanofi Pasteur for twenty-eight years, most recently in the position of senior director, Head of North American Regulatory Affairs. Joe teaches graduate-level courses in the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance program. He holds a Master of Science degree in Quality Assurance and Regulatory Affairs, Master of Science degree in Chemistry, Bachelor of Science degree in Biochemistry, and Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.

 
The Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20850
 

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
 
Day One: 
  • 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: 
  • 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

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.
 
​Training participants can receive 12 RAC Credits.






Can not attend, but considering another time? Sign up to stay informed about other upcoming events. 
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