RAPS Workshop: Biologics CMC: Regulatory Challenges and Trends

All stages of the drug development lifecycle require the proper adherence to regulatory chemistry, manufacturing and control (CMC) requirements. Join this two-day workshop for an overview of CMC information, requirements, and best practices applicable to biological products. This course provides an enhanced understanding of CMC principles for drug substance and drug product, with emphasis on requirements in the US, Europe and other highly regulated regions.

The workshop is designed to orient biopharmaceutical professionals responsible for CMC activities to support regulatory submissions and provide an overview of technical issues that must be addressed in biologic product development, registration, and lifecycle management. These principles ensure that manufacturing processes consistently produce safe and effective biologics and that analytical programs confirm the quality attributes.

Attendees will have the opportunity to submit specific questions in advance. Instructors will address pre-submitted questions anonymously during the course.

Topics will include: 

• Biological product characteristics 
• CMC regulations and guidance applicable to biologics 
• Alignment of technical information to the eCTD structure
• Quality by Design
• Adventitious agents risk management 
• Source material, cell & seed banks 
• Upstream and downstream processing 
• Characterization and testing 
• Demonstrating comparability

Learning Objectives

Upon completion of this workshop, participants should be able to:

• Apply principles from the characterization, development, and registration of monoclonal antibodies to other biological product types
• Distinguish phase-appropriate regulatory agency expectations associated with biologicals characterization, development, production, and testing
• Discuss best practices in establishing a comprehensive CMC regulatory strategy for application to the lifecycle of biological products
• Apply Quality by Design principles as they relate to development, manufacturing, characterizations, and testing of biological products
• Align biological CMC strategies with regulatory requirements to produce high-quality submission content, for all eCTD sections of Module 3

Who Should Attend?

This program will benefit early and mid-career regulatory professionals working in development, registration and post approval lifecycle management for biological products. Other technical subject matter experts, including development, technical operations, quality, etc., will gain value in learning the regulatory implications of product development. There are no prerequisites for participation, but some experience with pharmaceutical and/or biologicals development is recommended.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Agenda

Day 1 

Day 2 

***Agenda is subject to change

Cancellations and Refunds

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 [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

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 [email protected] with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

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

Speakers

Pat Cash

Analytical/Regulatory Expert in Biotechnology, Independent Consultant

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Nicole Damour

Director, Regulatory Affairs - CMC, Prothena Biosciences

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