Manufacturing

31. Advancing Allogeneic Cell Therapy for SCI and Blindness with Lineage's Brian Culley 10/22/2025

    On episode 114 of Cell & Gene: The Podcast, Host Erin Harris talks to Brian Culley, CEO of Lineage Cell Therapeutics, about advancing cell therapy beyond oncology and into transformative treatments for conditions such as spinal cord injury and blindness.

32. A Stem Cell-Derived Treatment For T1D 8/22/2022

    Sernova Corp. is a clinical-stage regenerative therapies company currently focused on insulin-dependent diabetes. CEO and President, Philip Toleikis, Ph.D., details the company's on-going clinical trial to treat Type 1 diabetes (T1D) as well as the very real potential to progress from simply masking symptoms to having a functional cure for T1D. Toleikis also provides his take on the near-term future of regenerative medicine.

33. 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.

34. 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.

35. 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,

36. 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.

37. 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.

38. 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.

39. Planning For Manufacturing Capacity With Kite Pharma's Will Junker 9/26/2022

    Will Junker, Head of Manufacturing Quality at Kite Pharma, talks to Cell & Gene: The Podcast listeners about the challenges associated with capacity planning, whether to partner with a CDMO, and why it's important to prioritize inventory over time-to-market. We also discuss why developing a better understanding of the vector manufacturing process is critical to bringing continuous and secure supply to market.

40. 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.