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: An All-In-One Approach for Small-Volume Cell Processing From Washing to Final Formulation, Fill, and Finish

  • The first step to successful automation is simplification
  • Closing critical last steps, removing risk and improving consistency in your final drug product
  • Overcoming the automated technology gap in cell washing and final formulation
  • Introducing closed-system automation for leukapheresis cryo prep and fill/finish
  • Illustration of demonstrated improvement on final product quality vs time
  • Comparative analysis of automating up and downstream processing in an all-in-one system

Alaina Schlinker, Senior Manager, Field Application Support Team, ScaleReady


12:05pm Closing Panel with Q&A

With all session participants

Karen Walker, Chief Technology Officer, Kyverna Therapeutics


Alaina Schlinker
Senior Manager, Field Application Support Team
George Buchman
Vice President, Pre-Clinical and Process Development
Catalent Cell and Gene Therapy
Gregg Nyberg
Chief Technology Officer
Landmark Bio
Karen Walker
Chief Technical Officer
Kyverna Therapeutics
Marc Wolfgang
Vice President of Technical Development
Ricardo Baptista
Chief Technology Officer
Alder Therapeutics