Biologics CMC: Regulatory Challenges and Trends

RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 20 January 2022 (9:00 AM) - Friday, 21 January 2022 (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. 

This workshop 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

21 December 2021 – 20 January 2022: $970 Member | $1,150 Nonmember


  • Identify various types of biologics products and their structural/functional characteristics
  • Distinguish phase-appropriate regulatory agency expectations associated with biologics characterization, development, production, and testing
  • Become familiar with best practices in establishing comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy for application to the lifecycle of biological products
  • Understand 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 modules 2 and 3 of the CTD


Day 1

9:00-9:30 a.m. Introduction to biopharmaceuticals
9:30-10:00 a.m. Biologics Product Characteristics and Regulatory Implications
10:00-10:30 a.m. CMC Regulation and guidances
10:30-10:45 a.m. Break
10:45-11:30 a.m. Quality by design, ICH 8-12
11:30-12:00 p.m. Clinical phase-appropriate CMC
12:00-1:00 p.m. Lunch break
1:00-1:30 p.m. Introduction to eCTD
1:30-2:15 p.m. eCTD Strategy S.1
2:15-2:30 p.m. Break
2:30-3:00 p.m. eCTD Strategy S.2 Upstream
3:00-3:30 p.m. eCTD Strategy S.2 Downstream and Formulation

3:30-4:00 p.m. Breakouts: Review of CRL

Day 2
9:00-10:00 a.m. eCTD 3.2.S.3 Characterization and impurities
10:00-10:30 a.m. eCTD 3.2.S.4 Control of DS
10:30-10:45 a.m. Break
10:45-11:45 a.m. eCTD 3.2.S.4.3 and 3.2.S.5 though 7
11:45-12:00 p.m. Breakouts: Review of CRL part 2
12:00-1:00 p.m. Lunch break
1:00-1:15 p.m. Report back from review of CRL part 2
1:15-1:45 p.m. Drug product considerations
1:45-2:15 p.m. Appendices and adventitious agents
2:15-2:30 p.m. Break
2:30-3:30 p.m. Comparability and biosimilars
3:30-4:00 p.m. Q&A

*Agenda is subject to change.


Patricia Cash

Patricia Cash, PhD 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.

Joe Quinn

Joe Quinn, MS, RAC 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.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.


For additional hands-on support, you can connect with RAPS support 30 min prior to the workshop:

For account support, contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email 

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