Biologics CMC: Phase Appropriate Product Development

12.0
RAC Credits
Tuesday, 13 July 2021 (9:00 AM) - Wednesday, 14 July 2021 (4:00 PM) Eastern Time (US & Canada)

With an emphasis on product development challenges and regulatory expectations in the US, Europe and other highly regulated regions, this workshop provides an in-depth study of chemistry, manufacturing and controls (CMC) product development requirements and best practices associated with biologics, and biosimilars.

Specifically designed for RA/QA professionals, managers and scientists responsible for biopharmaceutical CMC development and preparation of dossiers, this in-depth discussion will take a regulatory approach to the technical issues that arise during biologic product development and registration.

Topics will include:
• Biological product development from early phase to commercialization
• Source material
• Cell & seed banks
• Upstream and downstream processing, formulation and final product production
• Characterization and testing
• Demonstrating comparability
• CMC regulations and guidance applicable to biologics
• Quality by Design
• Adventitious agents risk management

Pricing Amounts & Deadlines 
17 November 2020 – 14 June 2021: $800 Member | $900 nonmember
15 June 2021 – 12 July 2021: $900 Member | $1000 nonmember


Objectives 
At the conclusion of this workshop, participants should:
• Be familiar with various types of biologic products and their structural/functional characteristics
• Understand development phase-appropriate regulatory agency expectations associated with biologics characterization, development, production and testing
• Understand best practices in establishing a comprehensive chemistry, manufacturing, and controls (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
• Translate an effective biologics CMC strategy into effective regulatory submission content for biologic and biosimilar products


Who Should Attend?
This program will benefit early, mid-career, and senior SMEs and regulatory professionals in CMC working in development, registration and post-approval lifecycle management for biological products. There are no prerequisites for participation. It is recommended that Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges be taken prior to this course for early career SMEs.


Agenda

Day 1 – Tuesday, 13 July 2021

9:00 am – 9:15 am           Introductions, announcements, and overview of class

9:15 am – 9:45 am           Overview of types of biologic products

9:45 am – 10:45 am        Regulation of biological products in US 

10:45 am – 11:00 am      Q and A and Break

11:00 am – 12:00 pm      Approach to product design and development and CMC teams

12:00 am – 1:00 pm        Lunch

1:00 pm – 2:00 pm          Early stage Manufacturing Process

2:00 pm – 2:30 pm          CMC physicochemical testing on biological products

2:30 pm – 2:45 pm          Q and A and Break

2:45 pm – 3:15 pm          Quality attribute risk assessment

3:15 pm – 3:45 pm          Risk assessment from Process perspective

3:45 pm – 4:00 pm          Q and A, End of day 1!

 

Day 2 – Wednesday, 14 July 2021

9:00 am – 9:30 am           Biofunctionality/ Potency assessment

9:30 am – 10:00 am        Comparability studies in developmental stages

10:00 am – 10:30 am      Pre-IND meeting planning and strategy

10:30 am – 10:45 am      Q and A and Break

10:45 am – 11:45 am      Manufacturing Process Considerations

11:45 am – 12:00 pm      Q and A

12:00 am – 1:00 pm        Lunch

1:00 pm – 1:30 pm          Specifications and analytical methods

1:30 pm – 2:00 pm          Stability and Forced degradation studies

2:00 pm – 2:15 pm          Q and A and Break

2:15 pm – 3:00 pm          Adventitious agents risk mitigation

3:00 pm – 3:30 pm          Sterility assurance/aseptic processing

3:30 pm – 4:00 pm          Q and A and discussion, end of class!



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.


Erica Shane, Ph.D.
, Independent Biotechnology Consultant
Dr. Shane is senior biotechnology professional with over 25 years of experience in the biotechnology and pharmaceutical industry with in-depth experience in vaccine and monoclonal antibody process development, clinical manufacturing and technology transfer to internal and external partners. She is currently an independent consultant focused on CMC. She was previously Vice President, Process Development at Novavax where she had responsibility for all process and analytical development activities. In addition, she provided oversight of technology transfer, process validation and technical support for manufacturing. Dr. Shane received her doctorate degree from Carnegie Mellon University, and her bachelor's degree from the Massachusetts Institute of Technology, both in chemical engineering.


Event Policies

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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of 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. 


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