Key Considerations in Cell and Gene Therapy Manufacturing – CMC, Process and Regulatory
End-To-End Manufacturing and Downstream Bioprocessing
Upstream Bioprocessing Optimisation and Support for Early Development
Reducing Timelines with Innovative Scale Up and Scale Out Technologies
Achieving Operational Excellence in Cell and Gene Therapy Manufacturing

Key Considerations in Cell and Gene Therapy Manufacturing – CMC, Process and Regulatory

26 Jan 2022

15:30 Chairperson’s Opening
Barbara A. Binzak Blumenfeld, Shareholder, FDA & Biotechnology, Buchanan Ingersoll & Rooney PC

15:35 Closed Systems and Disruptive Solutions for Aseptic Process (Live-stream)

  • Development of an autologous therapeutic product intended for bone regeneration
  • Application of the quality by design methodology to identify unit operations for which an improvement is a high target
  • Process optimization through the development of automated solutions in a closed system

Carmen Brenner, Director of Manufacturing, Sciences and Technology (MSaT), Novadip

15:50 Critical Decision to Address the Viral Vector Manufacturing Shortage 

  • Current productivity and purification yields are still a bottleneck for viral vector manufacturing
  • Early decision on vector design and production strategy will influence manufacturing cost
  • Implementation of easily scalable technology at early stage can save some development time

Emilie Gateau, Platform Development Manager, Exothera

16:05 Building A Manufacturing and Logistics Framework for TCR-Engineered Cell Therapies (TCR-T)

  • Interconnected strategic aspects for autologous cell therapies
  • Developing manufacturing and supply chain strategies for cell therapy products
  • Outlook towards commercialization

Pinar Cicalese, Director, CMC Commercial Strategy, Immatics

16:20 Don’t Forget People! Innovation to Rapidly Scale a Resilient Workforce for Cell and Gene Therapy Manufacturing

  • Our workforce is the most precious asset we have but it is often overlooked, with more emphasis on infrastructure and technology innovations
  • The global workforce shortage is now severe, due to rapidly growing success in the advanced therapies sector confounded by vaccine production needs
  • Virtual reality provides safe, effective and measurable training that can scale beyond constraints of facility and trainer availability and can accelerate the learning path

Ivan Wall, Director of a National Training Centre for Advanced Therapies Manufacturing and Professor in Regenerative Medicine, Cell and Gene Therapy Bioprocessing, Aston University

16:35 Speaker Q&A and Panel Discussion


Barbara A. Binzak Blumenfeld
Shareholder, FDA & Biotechnology
Buchanan Ingersoll Rooney
Carmen Brenner
Director, Manufacturing Sciences and Technologies (MSaT)
Emilie Gateau
Platform Development Manager
Pinar Cicalese
Director, CMC Commercial Strategy