Accelerating Clinical Manufacturing: Progressing Novel Therapeutics

18 Jan 2023
11:00
Manufacturing Advanced Therapies Track
SPONSORED BY
Catalent Cell and Gene Therapy
Landmark Bio

11:00am Chair Introduction

Gregg Nyberg, Chief Technology Officer, Landmark Bio

 

11:05am Presentation: Autologous Cell Therapies: establishing feasibility for phase 1 manufacture

  • Establishing practical, meaningful process development requirements
  • Assessing and establishing material and supply chain requirements
  • Demonstrating phase 1 manufacturing readiness
Marc Wolfgang, Vice President of Technical Development, BioNTech

 

11:20am Presentation: AAV Platform Process: Continuous Improvement for First in Human Studies

  • Review progress and success since launching UpTempo Virtuoso™ AAV Platform Process for AAV viral vector development and GMP production
  • Advanced development of critical platform reagents and methods, including clonal HEK293 cells, and plasmids
  • Highlight key platform and advanced analytics to streamline in process and release testing

George Buchman, Vice President, Pre-Clinical and Process Development, Catalent Cell and Gene Therapy 

 

11:35am Presentation: Creating foundations for “simple” and scalable processing platforms

  • Some challenges of tech ops in a virtual startup
  • Some risks and mitigation strategies to support process and analytical development for the manufacture of allogeneic therapies from pluripotent stem cells.

Ricardo Baptista, Chief Technical Officer, Alder Therapeutics

 

11:50am Presentation: TBC

 

12:05pm Closing Panel with Q&A

With all session participants

Speakers

George Buchman
Vice President, Pre-Clinical and Process Development
Catalent Cell and Gene Therapy
Gregg Nyberg
Chief Technology Officer
Landmark Bio
Marc Wolfgang
Vice President of Technical Development
BioNTech
Ricardo Baptista
Chief Technology Officer
Alder Therapeutics