Autologous immunotherapies have evolved in recent years to bring breakthrough treatments to the market. However, the complexity of the production process often results in extended timelines and high manufacturing costs, limiting the scalability and application across therapeutic indications. Therefore, cell therapy providers continue to make new investments to develop standardized and optimized scale-out strategies while balancing the customized processes for each patient treatment.

In this webinar, Catalent presents a clinical-to-commercial perspective on autologous therapies. Professor Gerhard Bauer will discuss the current challenges associated with autologous therapies and Dr. James Crutchley will speak to the various solutions available for commercial scale-up of advanced therapeutics.

Our expert panel will provide insight into:

  • Challenges, advantages and disadvantages of several systems that are currently available for manufacturing of these advanced therapies
  • Manufacturing by Design Methodology developed by Catalent to deliver process efficiencies and scalability
  • How to achieve economies of scale by optimizing across the manufacturing supply chain

Featured Speakers

Gerhard Bauer

Professor of Hematology/Oncology and Director of GMP Facility
Editor-in-Chief - Molecular Therapy - Methods and Clinical Development
UC Davis School of Medicine


Professor Gerhard Bauer attended medical school in Vienna, Austria, and moved to the US in the late 1980s to run the HIV research laboratory at the University of Maryland at Baltimore. He later joined the Johns Hopkins University to develop stem cell gene therapy for HIV. At USC’s Children's Hospital Los Angeles, he developed clinical-grade stem cell gene therapy transduction and cell processing procedures. He developed, designed and implemented academic cell and gene therapy GMP facilities at USC, Washington University in St. Louis and UC Davis. At UC Davis he directs their GMP facility and oversees manufacturing of novel products for clinical trials conducted in several centers nationwide.

James Crutchley

Process Engineer
Catalent Cell & Gene Therapy

Dr. James Crutchley is responsible for process development workstreams on several cell therapy programs. With over 10 years’ experience in academia and industry, he has led GMP translation, scale-up, automation, and process efficiency activities for clients. James holds a PhD in stem cell bioprocess development from the University of Nottingham.

Date:  Tuesday, September 15, 2020
Time:  12pm ET / 9am PT
Duration:  1 Hour

Register now for this webinar