SOLD OUT – Biologics CMC: Phase Appropriate Product Development Challenges

When:  Apr 23, 2020 from 9:00 AM to 3:00 PM (ET)

23 April 2020 (9:00 am–4:30 pm EST)
24 April 2020 (9:00 am–3:00 pm EST)
Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20852

Learn how to handle technical issues affecting biologic product development.

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 control (CMC) product development requirements and best practices associated with biologics, biosimilars, gene therapy and cell therapy products.

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
Faculty Patricia Cash, PhD, Independent Biotechnology Consultant Joseph Quinn, Biologics Regulatory Consultant Mark Schenerman, CMC Biotech-MAS Consulting and University of Maryland – Baltimore County Location Regulatory Affairs Professionals Society HQ 5635 Fishers Lane, Terrace Level Rockville, MD 20852 Registration Fees Registration to 24 March 2020 RAPS Members: $1,050 Nonmembers: $1,150 Registration from 25 March to 16 April 2020 RAPS Members: $1,150 Nonmembers: $1,250 Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Registration Closes: 15 April 2020 Refund Deadline: 24 March 2020 RAC Credits: 12 RAC recertification credits upon completion of the program Will this meeting be recorded? No Proof of Attendance: An electronic letter of attendance will be sent upon request.

Day 1 (9:00 am – 4:30 pm)

  • Overview of types of biologic products (therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene therapies, cell-based therapies)
  • Establishing the TPP and QTPP, important drivers for product development
  • Quality by Design
  • Clinical-phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars. Each of the topics that follow will be discussed in depth from an early- and late-phase perspective of regulatory requirements
    • Cell substrates & source materials, cell banks (storage, testing and other requirements)
    • Upstream processing (preparation of media, fermentation, harvesting/recovery, critical process parameters, PAT)
    • Downstream processing (purification strategies, process impurities, clearance studies)
    • Final product formulation (stability issues, considerations in choosing storage temp)

Day 2 (9:00 am - 3:00 pm)

  • Clinical-phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars (continued). Each of the topics that follow will be discussed in depth from an early- and late-phase perspective of regulatory requirements
    • Characterization Testing
    • Determination of cQAs
    • Release and Stability Testing (Control Strategy)
    • Setting Specifications
    • Validation of analytical methods
  • Process validation
  • Post approval changes – what is required?
  • Adventitious agents risk management
  • Demonstrating comparability & comparability protocols

NOTE: The agenda may vary based on changing requirements.

    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 control (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.

Other Information

Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200.

Refund Deadline: 24 March 2020

Please note that 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.

Accommodation Options: Below is a list of nearby hotel properties near host venue.

Even Hotel Rockville (Walking Distance)
1775 Rockville Pike
Rockville, MD 20852
Reservations: +1 877 834 3613

Hilton Washington DC/Rockville Hotel (Walking Distance)
1750 Rockville Pike
Rockville, MD 20852
Reservations: +1 301 468 1100

Bethesda North Marriott Hotel
701 Marinelli Road
Bethesda, MD 20852
Reservations: +1 301 822 9200

Bethesda Marriott Suites
6711 Democracy Boulevard
Bethesda, MD 20817
Reservations: +1 800 228 9290