Biologics CMC: Future Trends, Current Trends and Regulatory Challenges

12.0
RAC Credits
In-Person
Thursday, 27 October 2022 (9:00 AM) - Friday, 28 October 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.

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

Pricing Amounts & Deadlines

24 November 2021 — 27 September 2022: Early Bird  Member $1,100 | $1,300  nonmember

28 September – 28 October 2022: Regular $1,300 Member | $1,525 Nonmember

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.

Agenda

Day 1 Thursday, 27 October 2022

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 Break
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  Lunch
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 Break
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, 28 October 2022

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  Break
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 Lunch
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 Break
2:30 pm – 3:30 pm Comparability and Biosimilars
3:30 pm – 4:00 pm Question and Answer



***Agenda is subject to change

Speaker(s)



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.

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 support@raps.org. 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 support@raps.org 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 at the following the workshop.


Questions

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

Search for Related Content


Biologics North America