How Are We Developing Necessary Manufacturing Capacity for Advanced Therapies?

18 Jan 2023
New & Enabling Technologies Track
Curate Biosciences

1:30pm Chair Introduction

Jeff Masten, Chief Operating Officer, Theragent


1:35pm Presentation: In-House Production vs. CDMO: Meeting The Challenges of Commercializing Cell and Gene Therapies

  • In this presentation, expert Peter Walters evaluates what cell and gene therapy developers can do to plan for long-term commercial success while so much change is underway at the lab bench
  • In a recent report produced by CRB, drawing on survey data from over 500 industry experts, Walters will discuss facility strategies to consider when deciding to scale out, such as utilization of a CDMO or in-house production. He will touch on drivers such as adequate manufacturing capacity, availability of skilled workers and cost implications
  • Diving into the survey data and past project experience, he will evaluate different case studies while outlining the business case for in house production, utilizing a CDMO and a hybrid model

Peter Walters, Fellow in Advanced Therapies, CRB


1:50pm Presentation: Interim in-house production, strategic path of a small biotech

  • Choosing CDMO to shorten time from lab to clinic
  • Designing products for commercialization
  • Scalability and licensing readiness

Mathias Svahn, Chief Executive Officer, NextCell Pharma AB


2:05pm Presentation: Use of Microfluidic Technology to maximize Patient Sample Potential and Simplify Manufacturing

  • Microfluidic approaches offer significantly and consistently improved recovery of naïve T cells with greater purity vs. centrifugal/density-based approaches
  • In addition, microfluidic processing results in both improved transduction and superior T cell expansion
  • Together, these benefits synergistically combine to create a significantly and consistently shorter manufacturing process (~4 days) reducing cost while increasing capacity

Tony Ward, Chief Technology Officer, Curate Biosciences


2:20pm Presentation: How Are We Developing the Necessary Manufacturing Capacity for Advanced Therapies? 

  • Importance of integration of the Development, QC, MSAT, and Mfg Ops
  • Full control of supply chain and production scheduling is key
  • A purpose-built plant that speeds delivery of clinical supplies and is designed for commercial expandability

David Sourdive, Executive Vice President CMC and Manufacturing, Cellectis


2:35pm Closing Panel with Q&A

With all session participants, joined by: 

Julie G. Allickson, Director, Mayo Clinic Center for Regenerative Medicine & Associate Professor of Regenerative Medicine, Mayo Clinic


David Sourdive
Co-Founder and Executive Vice President CMC & Manufacturing
Jeff Masten
Chief Operating Officer
Julie G. Allickson
Director, Mayo Clinic Center for Regenerative Medicine & Associate Professor of Regenerative Medicine
Mayo Clinic
Mathias Svahn
NextCell Pharma
Peter Walters
Fellow, Advanced Therapies
Tony Ward
Chief Technology Officer
Curate Biosciences