Accelerating Clinical Manufacturing: Progressing Novel Therapeutics

18 Jan 2023
Manufacturing Advanced Therapies Track
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


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
Ricardo Baptista
Chief Technology Officer
Alder Therapeutics