Improving Novel Theraputics and Early-Phase Trials

Ryan Leahy
5 December 2022
Cell Therapy
Gene Editing
For this interview, Phacilitate’s Ryan Leahy speaks with Marc Wolfgang Vice President of Technical Operations for BioNTech U.S, about what to expect from his presentation ‘AAV Platform Process: Continuous Improvement for First in Human Studies’, at Advanced Therapies Week 2023.
Can you please introduce yourself?

My name is Marc Wolfgang, I am the Vice President of Technical Operations for BioNTech US and I oversee the manufacturing and supply chain for some of our cell therapies.

What are you currently working on?

I’m currently working on a clinical phase CAR-T product and two non-engineered T cell-based products, one of which is in the clinic and the other one is preparing for phase I.

What are the major challenges involved with clinical manufacturing?

There are obviously several well-known challenges with clinical manufacturing in the cell therapy space. What we primarily struggle with is process robustness and repeatability, cost, capacity and turnaround time.

What will you be talking about at Advanced Therapies week?

My topic of discussion will be based on the feasibility of doing phase I manufacturing for autologous cell therapies.

What do you expect to see in the future of cell and gene therapy, particularly when it comes to manufacturing?

I think we’ll see advanced technologies address these major hurdles in terms of cost of goods and turnaround time. I also anticipate platform-oriented process improvements in manufacturing, such as the automation of equipment and progress in the digital space. I also hope to see major advances in the analytical area.

Why are you excited for Advanced Therapies Week 2023?

It’s always nice to get people from the cell and gene therapy space together to share ideas, challenges, and advancements.


Don’t miss Marc’s presentation in the session, ‘Accelerating Clinical Manufacturing: Progressing Novel Therapeutics’ on Wednesday January, 18 2023.
Join us at Advanced Therapies Week >>