Ensure your manufacturing process consistently produces safe and effective biologics with lessons from experts in the chemistry, manufacturing, and control (CMC) process.
All stages of the drug development life cycle require the proper adherence to 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.
This workshop 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
Registration Fees & Deadlines
Present – 03 October 2025: Early Bird Member $865 |Nonmember $1,020
03 October 2025 – 03 November 2025: Regular Member $1,020 |Nonmember $1,200
Learning Objectives
- Describe various types of biologic products and their structural/functional characteristics
- Distinguish phase-appropriate regulatory agency expectations associated with biologics characterization, development, production, and testing
- Discuss best practices in establishing a comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy for application to the lifecycle of biological products
- Explain 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 early and mid-career regulatory professionals 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.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
Day 1
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9:00 am – 9:30 am
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Introduction to Biopharmaceuticals
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9:30 am – 10:00 am
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Biologics Product Characteristics and Regulatory Implications
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10:00 am – 10:30 am
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CMC Regulation and Guidances
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10:30 am – 10:45 am
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Break
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10:45 am – 11:30 am
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Quality by Design, ICH 8-12
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11:30 am – 12:00 pm
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Clinical Phase - Appropriate CMC
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12:00 pm – 1:00 pm
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Lunch
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1:00 pm – 1:30 pm
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Introduction to eCTD
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1:30 pm – 2:15 pm
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eCTD Strategy S.1
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2:15 pm – 2:30 pm
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Break
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2:30 pm – 3:00 pm
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eCTD Strategy S.2 Upstream
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3:00 pm – 3:30 pm
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eCTD Strategy S.2 Downstream and Formulation
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3:30 pm – 4:00 pm
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Break out - Review of CRL
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Day 2
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9:00 am – 10:00 am
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eCTD 3.2.S.3 Characterization and Impurities
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10:00 am – 10:30 am
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eCTD 3.2.S.4 Control of DS
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10:30 am – 10:45 am
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Break
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10:45 am – 11:45 am
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eCTD 3.2.S.4.3 and 3.2.S.5 through 7
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11:45 am – 12:00 pm
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Breakout Session - Review of CRL part 2
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12:00 pm – 1:00 pm
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Lunch
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1:00 pm – 1:15 pm
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Report Back from Review of CRL part 2
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1:15 pm – 1:45 pm
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Drug Product Considerations
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1:45 pm – 2:15 pm
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Appendices and Adventitious Agents
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2:15 pm – 2:30 pm
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Break
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2:30 pm – 3:30 pm
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Comparability and Biosimilars
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3:30 pm – 4:00 pm
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Question and Answer
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***Agenda is subject to change
Speakers
Pat Cash
Analytical/Regulatory Expert in Biotechnology, Independent Consultant
Nicole Damour
Director, Regulatory Affairs - CMC, Prothena Biosciences
Nicole has worked in the biopharma industry since 1999. Her experience spans from early to late stage product development, including registrational activities to support commercialization. She has worked on analytical method development and validation, small molecule and biologic drug product formulation (primarily liquid and lyophilized), scale-up, and process validation. Nicole has worked on over 50 development programs and contributed in both technical and regulatory roles to several approved NDA and BLA. She also has worked as a Chemistry Reviewer at FDA in CDER/OPQ/OLDP. She has a master’s degree in chemistry from The Johns Hopkins University and is currently working on a dissertation in the Regulatory Affairs and Quality Assurance program at Temple University School of Pharmacy.
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 support@raps.org. 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 support@raps.org 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
RAPS@raps.org