Biologics CMC: Phase Appropriate Product Development (April 2023)

RAC Credits
Thursday, 27 April 2023 (9:00 AM) - Friday, 28 April 2023 (4:00 PM) Eastern Time (US & Canada)
5635 Fishers Ln
Rockville, Maryland, USA, 20852-1796

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

December 7, 2022 - March 26, 2023: Early Bird $1135.00 member | $1340.00 nonmember

March 27, 2023 – April 27, 2023: Regular $1340 member | $1570.00 nonmember

Registration fee includes:

  • Breakfast and lunch each day
  • Continuous beverage break service
  • Complimentary WiFi
  • Complimentary Parking for Local Attendees

  • Learning Objectives

    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 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.


    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 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

    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 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.


    Patricia Cash

    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

    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

    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.


    5635 Fishers Lane
    Terrace Level
    Rockville, MD 20852

    Parking: Parking will be free at RAPS HQ with a validated ticket. Please make sure to bring your parking ticket to registration to validate parking. Overnight parking is not allowed.



    Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr 
    1750 Rockville Pike 
    Rockville, Maryland, 20852-1699, USA 
    Telephone: (301) 468-1100 
    Hotel Website 
    Distance to RAPS HQ: .8 miles 
    Directions to RAPS HQ 


    EVEN Hotel Rockville  
    1775 Rockville Pike 
    Rockville, MD 20852 
    Telephone: (301) 881-3836 
    Hotel Website 
    Distance to RAPS HQ: .7 miles 
    Directions to RAPS HQ 

    Vaccination Requirement

    RAPS will require proof of COVID-19 vaccination or proof of a negative PCR test taken within 24 hours of arrival in order to attend. Unvaccinated individuals or those unable to provide proof of vaccination or a negative PCR test will not be permitted to attend.

    RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.

    Be Well Policy

    Participants must follow RAPS’ Be Well policy, which requires consent during registration by all attendees as a condition of on-site participation. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while on site in St. Paul, you will reconsider your participation at the event. To help ensure your personal safety and comfort, RAPS is committed to robust and transparent communications. We encourage all participants to monitor RAPS’ social media channels to receive the latest updates.

    Cancellations and Refunds

    All cancellation requests must be submitted in writing to Cancellation requests received by Sunday; 11 September 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 11 September 2022 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.


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

    Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.

    Photography Policy

    By registering for this RAPS Event, you grant full permission to RAPS to capture, store, use, and/or reproduce your image or likeness, photograph, voice, and comments, and use such content in any and all media or forms by RAPS or third parties without compensation or notice, including for promotional or advertising purposes. You also waive any right to royalties or other compensation arising from or related to the use of the images, recordings, or materials. By registering, you release, defend, indemnify and hold harmless RAPS from and against any claims, damages or liability arising from or related to the use of the images, recordings or materials, including but not limited to claims of defamation, invasion of privacy, or rights of publicity or copyright infringement, or any misuse, distortion, blurring, alteration, optical illusion or use in composite form that may occur or be produced in taking, processing, reduction or production of the finished product, its publication or distribution.


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

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