Biologics CMC: Regulatory Challenges and Trends

RAC Credits
Thursday, 27 October 2022 (9:00 AM) - Friday, 28 October 2022 (3:00 PM) Eastern Time (US & Canada)
5635 Fishers Ln
Rockville, Maryland, USA, 20852-1796

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

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.


Thursday, October 27, 2022


9:00-9:30 – Introductions and overview of class

9:30-10:00 – Introduction to biopharmaceuticals

10:00-10:30 - Biologics product characteristics and regulatory implications

10:30-10:45 – Break

10:45-11:00 - CMC regulation and guidances

11:00- 12:00 – Quality by Design, ICH 8-12

12:00-12:30 Lunch

12:30-1:00 - Clinical Phase-Appropriate CMC

1:00-1:30 – Introduction to eCTD

1:30 - 2:15 – eCTD Strategy

2:15-2:30 - Break

2:30-3:30 - eCTD Strategy

3:30-4:00 – Break out - Review of CRL 

4:00-4:30 – eCTD Strategy, Questions


Friday, October 28, 2022

9:00-10:00 – eCTD 3.2.S.3 Characterization and Impurities

10:00-10:45 – eCTD 3.2.S.4 Control of DS

10:45-11:00 – Break

11:00 – 11:30 – eCTD 3.2.S.4.3 and 3.2.S.5 through 7

11:30 - 12:00 – Breakout session

12:00-12:30 lunch

12:30-1:00 – Breakout session recap

1:00 – 1:30 - Drug Product considerations

1:30 – 2:30 - Appendices and Adventitious Agents

2:30 - 3:00 – Comparability and Biosimilars

3:00 – Questions and Answers



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.

Registration Fees & Deadlines

Registration fee includes:

  • Breakfast and lunch each day
  • Continuous beverage break service
  • Complimentary WiFi
  • Complimentary Parking for local attendees




Early Bird by 28 September 2022



Regular by 26 October 2022




RAPS Headquarters:
5635 Fishers Ln
Terrace Level
Rockville, MD 20852


EVEN Hotel Rockville - Washington DC Area, an IHG Hotel
1775 Rockville Pike
Rockville, MD 20852


A limited number of rooms is available at the rate of $119.00 + tax.

Book online at Even Hotel Rockville or by phone: 855.879.3836

Group Code: CMC

Reservations must be made no later than 11 October 2022.


Parking $14.00 a day for overnight parking at the hotel

Complimentary Parking for local attendees:

5635 Fishers Lane Garage - ParkChirp

Vaccination Requirement

RAPS will require proof of COVID-19 vaccination or proof of a negative PCR test taken within 24 hours of arrival in order to attend. Unvaccinated individuals or those unable to provide proof of vaccination or a negative PCR test will not be permitted to attend.

RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.

Be Well Policy

Participants must follow RAPS’ Be Well policy, which requires consent during registration by all attendees as a condition of on-site participation. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while on site, you will reconsider your participation at the event. To help ensure your personal safety and comfort, RAPS is committed to robust and transparent communications. We encourage all participants to monitor RAPS’ social media channels to receive the latest updates.

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.

Photography Policy

By registering for this RAPS Event, you grant full permission to RAPS to capture, store, use, and/or reproduce your image or likeness, photograph, voice, and comments, and use such content in any and all media or forms by RAPS or third parties without compensation or notice, including for promotional or advertising purposes. You also waive any right to royalties or other compensation arising from or related to the use of the images, recordings, or materials. By registering, you release, defend, indemnify and hold harmless RAPS from and against any claims, damages or liability arising from or related to the use of the images, recordings or materials, including but not limited to claims of defamation, invasion of privacy, or rights of publicity or copyright infringement, or any misuse, distortion, blurring, alteration, optical illusion or use in composite form that may occur or be produced in taking, processing, reduction or production of the finished product, its publication or distribution. 


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.

Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.


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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