Biologics CMC: Regulatory Challenges and Trends

RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 02 February 2023 (9:00 AM) - Friday, 03 February 2023 (4:00 PM) Eastern Time (US & Canada)

Ensure your manufacturing process consistently produces safe and effective biologics.

All stages of the drug development life cycle require the proper adherence to chemistry, manufacturing and control (CMC) regulatory requirements. Join this two-day workshop for an introductory overview of CMC requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other highly regulated regions.

The class is designed to orient professionals, managers and scientists responsible for biopharmaceutical CMC activities in the preparation of dossiers as well as an overview of some of the technical issues that must be addressed in biologic product development, registration, and lifecycle management.

Topics will include: 

  • Biological product characteristics 
  • CMC regulations and guidance applicable to biologics 
  • Quality by Design
  • Adventitious agents risk management 
  • Source material, cell & seed banks 
  • Upstream and downstream processing 
  • Formulation and final product production 
  • Characterization and testing 
  • Demonstrating comparability

Registration Fees & Deadlines

15 November 2022 – 2 January  2023: Member $825.00 |Nonmember $970.00
2 January 2023 – 2 Feburary 2023: Member $970.00 |Nonmember $1,150.00

Learning Objectives 

  • Be familiar with various types of biologic products and their structural/functional characteristics
  • Be able to distinguish phase-appropriate regulatory agency expectations associated with biologics characterization, development, production, and testing
  • Be familiar with best practices in establishing a comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy for application to the lifecycle of biological products
  • Be familiar with Quality by Design principles as they relate to development, manufacturing, characterizations, and testing of biologic products
  • Translate an effective biologics CMC strategy into effective regulatory submission content for biological products, including all sections of module 2 and 3 of the CTD.

Who Should Attend? 

This program will benefit mid-career regulatory professionals in CMC working in development, registration and post approval lifecycle management for biologic/biosimilar products. CMC SMEs will gain value in learning the regulatory implications of product development. There are no prerequisites for participation.


Day 1 Thursday, 2 February 2023

9:00 am – 9:30 am

 Introduction to Biopharmaceuticals

9:30 am – 10:00 am

Biologics Product Characteristics and Regulatory Implications

10:00 am – 10:30 am

CMC Regulation and Guidances

10:30 am – 10:45 am


10:45 am – 11:30 am

Quality by Design, ICH 8-12

11:30 am – 12:00 pm

Clinical Phase - Appropriate CMC

12:00 pm – 1:00 pm


1:00 pm – 1:30 pm

Introduction to eCTD

1:30 pm – 2:15 pm

eCTD Strategy S.1

2:15 pm – 2:30 pm


2:30 pm – 3:00 pm

eCTD Strategy S.2 Upstream

3:00 pm – 3:30 pm

eCTD Strategy S.2 Downstream and Formulation

3:30 pm – 4:00 pm

Break out - Review of CRL

Day 2 – Friday, 3 February 2023

9:00 am – 10:00 am

 eCTD 3.2.S.3 Characterization and Impurities

10:00 am – 10:30 am

eCTD 3.2.S.4 Control of DS

10:30 am – 10:45 am


10:45 am – 11:45 am

eCTD 3.2.S.4.3 and 3.2.S.5 through 7

11:45 am – 12:00 pm

Breakout Session - Review of CRL part 2

12:00 pm – 1:00 pm


1:00 pm – 1:15 pm

Report Back from Review of CRL part 2

1:15 pm – 1:45 pm

Drug Product Considerations

1:45 pm – 2:15 pm

Appendices and Adventitious Agents

2:15 pm – 2:30 pm


2:30 pm – 3:30 pm

Comparability and Biosimilars

3:30 pm – 4:00 pm

Question and Answer

***Agenda is subject to change


Patricia Cash, PhD
Independent Biotechnology Consultant

Dr. Patricia W. Cash, Ph.D. is a senior leader with over 30 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.

Joseph Quinn
Biologics Regulatory Consultant

Joe Quinn is an independent Regulatory Affairs Consultant with 35 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.

Cancellations and Refunds

All cancellation requests must be submitted in writing to Cancellation requests received by Thursday; 13 October 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 13 October 2022 will be non-refundable, except in cases of documented medical emergencies.   RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.


Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email

Discover more of what matters to you

News »