In these unprecedented times, the world has become acutely aware of the need for quality, consistency, and continuity in pharmaceutical supply chains, from raw materials to finished products.
This USP workshop will focus primarily on upstream raw materials for manufacturing of biologics including recombinant proteins, cell and gene therapies, and vaccines. Presentations and case studies from subject matter experts will address control and evaluation of raw materials, supplier risk management, and strategies to minimize process variability due to these materials. Cell culture media and additives can be particularly complex and will be a part of the discussion. Regulators will also share their perspective on expectations for these materials.
Panel discussions and networking events will allow audience members to engage with the speakers and USP staff on challenges that they face and opportunities to develop best practices and standards.
Key Session Topics
- Setting specifications for raw or ancillary materials
- Identification and characterization of impurities in raw materials
- Performance testing to demonstrate fit-for-purpose
- Developing stability-indicating assays
- Quality systems for raw materials
- Case studies sharing successes, failures, and lessons learned due to raw material issues
- Cell and gene therapy (advanced therapy medicinal products) raw material qualification and differentiation with starting materials
- Safety and qualification of biologically derived/complex materials
- Supplier risk management
- Setting expectations based on raw material attributes and process impact
- Analytical strategies to tie raw material quality attributes to process performance
- Existing and future documentary standards and reference standard materials to support raw materials
The Steering Committee
- Mehrshid Alai, Ph.D., Head of Global Regulatory CMC, Kite Pharma
- Christopher Bravery, Ph.D., Consulting Regulatory Scientist & Director, Advbiols
- Yao-Ming Huang, Ph.D., Engineering Advisor, Eli Lilly & Co.
- Clarice Hutchins, Ph.D., Senior Director, Pfizer
- Maura Kibbey, Ph.D., Senior Scientific Fellow, USP
- Atanas Koulov, Ph.D., Head of Analytical Development & QC, Lonza
- Katie Parks, Ph.D., Director of Quality Control, Amgen
- Rajesh Patel, M.Sc., QA Manager, Bristol-Myers Squibb
- Bala Ramanathan, Ph.D., Senior Scientist, Janssen-J&J
Who Should Participate?
- QA/QC analysts
- Manufacturing and process development scientists, managers
- Quality and regulatory staff supporting supplier evaluation, agreements, and audits
- Contract research organizations
- Contract manufacturing organizations
- Reagent vendors
Call for abstracts
Interested in submitting an abstract for the workshop? We want to hear from you! Get information about topics and submission instructions.
Registration and Pricing Information
Registration is payable by credit card only. Updated registration fees for this virtual 3-day workshop have been set as follows:
|Participant type||Regular fee, per person|
Cancellation and Substitution Policy
Cancellation must be received on or before April 6, 2021 via email to firstname.lastname@example.org Refunds will not be issued for cancellations received after this date. It is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to email@example.com
Please contact firstname.lastname@example.org or +1 301-816-8130.