Manufacturing

1. The Promise Of AAV Gene Therapy With REGENXBIO's Ken Mills 11/8/2023

   Ken Mills, CEO, President, and Director at REGENXBIO joins Erin Harris for this episode of Cell & Gene: The Podcast to discuss the company's progress with its Phase I/II Affinity Duchenne trial of RGX-202 for the treatment of Duchenne Muscular Dystrophy. They discuss the future of AAV gene therapy as well as achieving scalability with consistent yield and product purity in gene therapy manufacturing.

2. Manufacturing at the Point of Care with Orgenesis' CEO Vered Caplan 11/28/2022

   Orgenesis' CEO, Vered Caplan explains the business model behind providing cell and gene therapies that may be manufactured at the point of care. She details how working with hospitals and healthcare providers to enable them to participate in CGT development on their sites and providing these therapies in-house by adapting them to closed system manufacturing rather than relying on the typical biotech model is an important step forward in CGT manufacturing.

3. The Why Behind In-House Manufacturing With Sangamo's Andy Ramelmeier 2/13/2023

   On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Andy Ramelmeier, EVP Head of Technical Operations at Sangamo Therapeutics, a biotech based in Brisbane, California that applies cell and gene therapy to combat Hemophilia A and other genetic diseases. Ramelmeier explains the why behind the company's decision to build its own Phase 1/2 cGMP AAV in-house facility. He also talks broadly about manufacturing cell and gene therapies and the potential and realistic solutions to needed to drive down manufacturing costs.

4. An Interview With Dr. Carl June 8/9/2022

   Dr. Carl June, an HIV gene therapy pioneer and the father of CAR-T cell therapy, joins Cell & Gene: The Podcast to discuss the current state of CAR-T therapy, what's on the short-term horizon for immunotherapy, ongoing manufacturing capacity issues, an update on Emily Whitehead, the first child to receive CAR-T cell therapy on an experimental basis, and more.

5. 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.

6. Cell Therapy's Current Manufacturing Challenges 4/15/2025

   In this segment, Cell & Gene’s Chief Editor, Erin Harris, welcomes the audience and introduces the expert panelists, Rohit Ingale, Head of Manufacturing & MSAT, Arcellx and David O’Donnell, Vice President, Head of Manufacturing, Vor Bio.

7. 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.

8. 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.

9. Commercialization Learnings With Novartis Gene Therapies' President Chris Fox 9/7/2022

   With 20+ gene therapy targets in Novartis Gene Therapies’ pipeline, President Chris Fox and her team are hyper-focused on newborn screenings as the pathway to helping more and more patients. The company's initial gene therapy, Zolgensma, for spinal muscular atrophy (SMA) has been approved in more than 40 regions and countries and has been used to treat more than 2,300 patients worldwide. Fox details what’s next on the commercialization front for the therapy, and she shares advice with Cell & Gene: The Podcast listeners about what it takes to commercialize a therapy,

10. Lessons in Automation with Roswell Park Comprehensive Cancer Center's Christopher Choi, Ph.D. 1/1/2025

    On Cell & Gene: The Podcast, Erin Harris interviews Dr. Christopher Choi of Roswell Park Comprehensive Cancer Center about the upcoming cell and gene therapy hub in Buffalo, NY, set to open in 2025. They delve into the transformative role of automation and digital technologies in CGT manufacturing. Dr. Choi also shares practical advice for emerging CGT biotechs on navigating manufacturing challenges during early product development.