Operational Excellence for Advanced Therapies

19 Jan 2023
Manufacturing Advanced Therapies Track
Sartorius Stedim Biotech

13:30pm Chair Introduction

Anthony Ting, Principal, BRL C&GT Consulting


13:35pm 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 CMC & Manufacturing, Cellectis


13:50pm 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


14:05am 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


14:20am Presentation: Overcoming Cell Processing Challenges in Advanced Therapies with Ksep50®

Process variability, viability, and recovery are key challenges in cell-based therapy manufacturing. Ksep®50 is a counterflow centrifuge designed to address these challenges.

  • Through the balance of centrifugal and hydrodynamic forces, Ksep50 reduces shear forces, resulting in higher cell viability and recovery.
  • Ksep®50 automates cell separation, concentration, wash, and harvest processes in cell therapy manufacturing to reduce the process variability.
  • Application data confirms, Ksep50 achieved high recovery of cells while keeping the viability and functionality.

Ksep®50 is a truly versatile system to handle various cell types and multiple unit operations in closed cell processing

Jordan Fabry, Product Specialist – Clarification Studies, Separations Technologies North America, Sartorius Stedim Biotech


14:35pm Closing Panel with Q&A

With all session participants


Anthony Ting
Principal, BRL C> Consulting
David Sourdive
Co-Founder and Executive Vice President CMC & Manufacturing
Irina Kadiyala
Senior Director & Head, Heme Process Development
Vertex Cell and Gene Therapies
Jordan Fabry
Product Specialist - Clarification Studies, Separations Technologies North America
Sartorius Stedim Biotech
Rob Tressler
Chief Scientific Officer