Process Development & Manufacturing Committee

Charter

The Process Development & Manufacturing Committee strives to establish and communicate best practices in process development & manufacturing as it relates to therapeutic cell and gene therapy products by assessing emerging process and analytical technologies and forecasting their impact on:

• Translation of activities beyond process development
• Wider industrialization of Cell and Gene Therapies 

Topics of interest to the PDM include, but are not limited to:

• Scale up & out challenges
• Single-use systems for manufacturing
• Process analytics
• Automation and robotics
• Digital solutions
• Cryopreservation
• Supply chain management
  

Selected Publications

• Impact considerations of post-production processes on cell and gene drug products (2022)
  
  

Co Chairs

PDM Committee Members

Given the breath of topics the Committee addresses, working groups were established to provide individuals with the opportunity to dive deeper into specific manufacturing modules. PDM Committee Members each contribute to a PDM Working Group. Full member rosters can be found on each of the working group pages.

• Cold Chain Management & Logistics Working Group (CCML)
• Emerging Regenerative Medicine Technology Working Group (ERMT)
• Manufacturing Materials Safety & Technology Working Group
• Process Automation, Analytics & Development Working Group (PAAD)