11:00am Chair Introduction

Gregg Nyberg, Chief Technology Officer, Landmark Bio

11:05am Presentation: Autologous Cell Therapies: Establishing Feasibility for Phase 1 Manufacture

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