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SOLD OUT - Biologics CMC: Phase Appropriate Product Development Challenges - August 2020

12.0
RAC Credits
Wednesday, 05 August 2020 (9:00 AM) - Thursday, 06 August 2020 (5:00 PM) Eastern Time (US & Canada)

In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as an online workshop. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.


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
Online Workshop

Registration Fees

Registration 6 July 2020  
RAPS Members:  $800
Nonmembers:  $900

Registration from 7 July 4 August 
RAPS Members:  $900
Nonmembers:  $1,000


Advance registration is required for this workshop. Participants are encouraged to register early. 

Registration Closes:                         4 August
RAC Credits:                                     12 RAC
Will this meeting be recorded?       Yes – recordings are only accessible post-event to program registrants.  
Proof of Attendance:                        An electronic letter of attendance will be sent following the conclusion of the workshop.


Program Schedule

Day 1 (9:00 am – 5:00 pm EDT)

  • 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 – 5:00 pm EDT)

  • 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.


Cancellation or Substitutions

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. Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived.  Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.  Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event. 

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

Program Contact
Stephany Evans, Meeting & Events Specialist
sevans@raps.org
1 301 770 2920 x 229
Register