Event Details

This event is sold out. The next instance of Biologics CMC: Phase-Appropriate Product Development will be held on 13 & 14 July 2021. Click here to learn more.

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, 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:

• Biologic product development from early phase to commercialization
• Source material
• Cell and 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

16 November 2020–11 January 2021: $800 Member| $900 nonmember

12 January 2021-8 February 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 of 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 subject matter experts (SMEs) and regulatory professionals in CMC working in development, registration and post-approval lifecycle management for biologic 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 (9:00 am – 4:00 pm EDT)

• Overview of types of biologic products (therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene therapies, cell-based therapies)
• Regulation of biologics in the US
• Establishing the TPP and QTPP and product teams
• 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. Early stage requirements will be emphasized in day one and later phase in day two.
• Cell substrates and source materials, cell banks (storage, testing and other requirements) 
• Upstream processing (preparation of media, fermentation, harvesting/recovery, critical process parameters) 
• Downstream processing (purification strategies, process impurities, clearance studies)
• Final product formulation (stability issues, considerations in choosing storage temp)
• Characterization testing
• Determination of CQA
• Release and stability testing (control strategy)
• Setting specifications 
• Validation of analytical methods

 Day 2 (9:00 am – 4:00 pm EDT)

• Comparability studies during the development stages
• Pre-IND meeting planning and strategy
• Clinical-phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars (continued from day one for later stage products).
• Process development and validation
• Post-approval changes—what is required?
• Adventitious agents risk management 
• Sterility assurance/aseptic processing

NOTE: The agenda may vary based on changing requirements.

 Speakers

Patricia Cash, PhD, Independent Regulatory Consultant

Patricia W. Cash is a senior leader with more than 30 years of 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 PhD and a master’s in chemistry from Rutgers University, and an MBA in technology management from University of Phoenix.

Joseph Quinn, Biologics Regulatory Consultant

Joe Quinn is an independent regulatory affairs consultant with 35 years of experience in the biologics and vaccines industry, including assignments in quality control, research, product development and scale-up, bioanalytical development and validation, project management, and regulatory affairs. He was employed by Sanofi Pasteur for 28 years, most recently in the position of senior director, head of North American regulatory affairs. He teaches graduate level courses in the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance program. He holds master’s degrees in quality assurance and regulatory affairs, and Chemistry, and has earned Regulatory Affairs Certification (RAC).

Erica Shane, PhD, Independent Consultant

Erica Shane is senior biotechnology professional with more than 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. She received her doctorate from Carnegie Mellon University in chemical engineering.

Cancellation Policy

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.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. 

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.