Operational Excellence for Advanced Therapies

19 Jan 2023
Manufacturing Advanced Therapies Track

11:00am Chair Introduction

Frank Thielmann, Head Lean, Global Operational Excellence, Takeda


11:05am Presentation: Stepping Up the Game for the Next Generation Cell Therapy Products

  • Cell therapies are transitioning from grafts to off-the-shelf robust and controlled pharmaceutical products
  • Advanced genomic designs leverage excellence in gene editing and opens the era of “smart cells”
  • Integrating manufacturing for genomic engineering and cell therapy opens new therapeutic avenues for unmet needs

David Sourdive, Co-Founder and Executive Vice President, Cellectis


11:20am Presentation: Starting Material Characterization to Optimize the Cellular Active Pharmaceutical Ingredient (cAPI) Content in Final Products for Adoptive Immunotherapies

  • Data showing the variability and lack of robust durable responses in current immunotherapy trials with CAR-based treatments
  • Characterization data demonstrating the variability in cAPI for some currently used immunotherapies
  • Excellos paradigm for addressing effector function, metabolic assessment and donor cell repertoire characterization to identify preferred donors for optimal starting material collection

 Robert Tressler, Chief Scientific Officer, Excellos


11:35am Presentation: Particulate Control Strategy in CGT Manufacture

  • CGT manufacturing is not particulate free and might have intrinsic particulates
  • There is no adequate regulatory guidance to handle particulates in CGT products
  • Strategy has been put in place to minimize particulates in the process through material quality and manufacturing controls with the focus on particulate characterization. Drug product disposition and release for administration is supported by the identification procedure of particulate

Irina Kadiyala, Senior Director, Process Engineering, Vertex Pharmaceuticals


11:50am Presentation: TBA

Senior Representative, TrakCel


12:05pm Closing Panel with Q&A

With all session participants


David Sourdive
Co-Founder and EVP CMC & Manufacturing
Frank Thielmann
Head Lean, Global Operational Excellence
Irina Kadiyala
Senior Director & Head, Heme Process Development
Vertex Cell and Gene Therapies
Rob Tressler
Chief Scientific Officer