Manufacturing

1. Dr. Bruce Levine on ISCT and the Future of CAR-T 5/23/2024

   In anticipation of ISCT 2024 in Vancouver, Canada, Dr. Bruce Levine is back on Cell & Gene: The Podcast to share information about the event as well as his expertise on the future of CAR-T therapy for solid tumors, autoimmune disease, and more.

2. CMC And Scale Up With Mustang Bio's Robert Sexton 1/19/2023

   Mustang Bio's Robert Sexton, VP Program and Alliance Leadership, explains the why behind the need for this role in any CGT company. Having worked for Novartis, Sanofi, Legend Biotech, and more, with responsibilities having included quality, operations, and order management, Sexton is currently responsible for aspects of CMC. As such, he addresses the industry's top CMC challenges as well as sound advice for future scale up.

3. Breaking Down Solid Tumors With Triumvira Immunologics' Dr. Paul Lammers 1/17/2024

   Paul Lammers, M.D., M.Sc., CEO of Triumvira Immunologics joins Cell & Gene: The Podcast to talk to Host Erin Harris about TAC, the company's proprietary T cell Antigen Coupler, which has both autologous and allogeneic approaches. They also discuss targeting relapsed or refractory HER2-positive solid tumors and CLDN18.2-positive solid tumors. And they cover a realistic outlook on the evolution of cancer treatment.

4. In Vivo CAR T-Cell Therapeutics With Umoja Biopharma's Dr. Andrew Scharenberg 9/26/2023

   Discuss the evolution of allogeneic, in vivo CAR-T cell therapeutics, recent progress in lentiviral vector manufacturing, and The Colorado Laboratory and Innovation Manufacturing Building.

5. TJU's Jefferson Institute for Bioprocessing's Impact on CGT with Parviz Shamlou 5/10/2023

   Parviz Shamlou, Vice President and Executive Director at Thomas Jefferson University joins Cell & Gene: The Podcast to talk to Host Erin Harris about Jefferson Institute for Bioprocessing (JIB), the full-service development and training organization specializing in biopharmaceuticals and biologics. Shamlou explains how JIB will move forward cell and gene therapies as well as JIB’s partnership with NIBRT (National Institute for Bioprocessing Research & Training), and much more.

6. An Interview with Dr. Peter Marks 1/5/2023

   Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA) sits down with Cell & Gene: The Podcast host Erin Harris to discuss the most anticipated areas of innovation in clinical development, and he offers recommendations to companies in their engagement with the FDA in order to make manufacturing more streamlined and cost effective. Dr. Marks also provides advice to listeners about how and when to engage with CBER, and much more.

7. Computational Biology's Role In Gene Therapy With Kriya Therapeutics' Dr. Shankar Ramaswamy 4/26/2023

   Shankar Ramaswamy, M.D., CEO & Co-Founder, Kriya Therapeutics joins Cell & Gene: The Podcast's Erin Harris for a discussion on the evolving role computational biology plays in gene therapy development. They also discuss the company's lessons learned from building its own North Carolina-based in-house manufacturing facility as well as Ramaswamy's insight on the future of gene therapy.

8. Advancing Off-The-Shelf CRISPR CAR-T Therapies Into The Community Setting With Caribou Biosciences' Rachel Haurwitz 1/13/2026

   On episode 120 of Cell & Gene: The Podcast, Host Erin Harris is joined by Rachel Haurwitz, CEO of Caribou Biosciences, to discuss the company’s progress in developing CRISPR-edited, off-the-shelf CAR-T therapies for hematologic malignancies.

9. Inside Yescarta's Reduced Median Turnaround Time with Kite, a Gilead Company's Christopher McDonald 2/13/2024

   On this episode of Cell & Gene: The Podcast, Christopher McDonald Global Head of Technical Operations at Kite, a Gilead Company, talks to Host Erin Harris about Kite's recent FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta. They talk through the most significant steps Kite took to reach this approval, lessons learned from having worked with the FDA, scaling up technologies for cell therapy manufacturing, and more.

10. Inside NK and Macrophage Cellular Immunotherapies 12/22/2022

    Shoreline Biosciences' Chief Scientific Officer Dr. Robert Hollingsworth shares his insight on intelligently designed allogeneic off-the-shelf, standardized, and targeted iPSC-derived natural killers (NK) and macrophage cellular immunotherapies. He explains the company's preclinical testing on a potential NK cell therapy for acute myeloid leukemia. We discuss how the field recognizes the importance of off-the-shelf NK cell therapy not only for cost reduction but also for improving safety measures. As such, Dr. Hollingsworth talks through why NK cells necessary to move immunotherapies forward.