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This workshop is sold out, but will be repeated 14 - 15 December, 2021. Details can be found here:
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
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
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!
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 firstname.lastname@example.org with the event title, name of the original registrant and the contact information for the new attendee.