Operational Excellence for Advanced Therapies

19 Jan 2023
13:30
Manufacturing Advanced Therapies Track
SPONSORED BY
TrakCel

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

Speakers

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