Biologics CMC: Phase Appropriate 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.

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
  
  

Pricing Amounts & Deadlines

21 November 2021 – 21 June 2022: Early Bird $825 member | $970 nonmember

22 June 2022 – 22 July 2022: Regular $970 member | $1,150 nonmember

Learning Objectives 

• 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 subject matter experts (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.

Agenda

• 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 1 and later phase in day 2.
  • 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)
  • Characterization Testing
  • Determination of cQAs
  • Release and Stability Testing (Control Strategy)
  • Setting Specifications
  • Validation of analytical methods

• 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 1 for later stage products).
• Process development and validation
• Post approval changes – what is required?
• Adventitious agents risk management
  
• Sterility Assurance/Aseptic Processing
  
  

: The agenda may vary based on changing requirements.

Speaker(s)

Patricia Cash, PhD, Independent Biotechnology Consultant

Dr. Patricia W. Cash, Ph.D. is a senior leader with over 30 years 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 Masters of Science degree in Chemistry from Rutgers University, Bachelor of Arts degree in Chemistry from The King’s College, and a Masters of Business Administration, Technology Management from University of Phoenix.

Joseph Quinn, Biologics Regulatory Consultant

Joe Quinn is an independent Regulatory Affairs Consultant with 35 years experience in the biologics and vaccine industry, including assignments in quality Control, research, product development & scale-up, bioanalytical development & Validation, project management, and regulatory affairs. Joe was employed by Sanofi Pasteur for 28 years, most recently in the position of senior director, Head of North American Regulatory Affairs. Joe teaches graduate-level courses in the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance program. He holds a Master of Science degree in Quality Assurance and Regulatory Affairs, Master of Science degree in Chemistry, Bachelor of Science degree in Biochemistry, and Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.

Erica Shane, Ph.D., Independent Biotechnology Consultant

Dr. Shane is senior biotechnology professional with over 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. Dr. Shane received her doctorate degree from Carnegie Mellon University, and her bachelor's degree from the Massachusetts Institute of Technology, both 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 to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

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

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions