Manufacturing

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. CGT Manufacturing: Distributed & Digital with Deloitte Consulting's Omkar Kawalekar, Ph.D. 2/25/2025

    Omkar Kawalekar, Ph.D., Senior Manager, NextGen Therapies Manufacturing & Supply Chain Lead, Deloitte Consulting joins Host Erin Harris to share his expert take on how distributed manufacturing models address capacity constraints and supply chain risks, the role of automation in reducing batch-to-batch variability, as well as the power of digital technologies in optimizing production processes. He also covers the key considerations for CGT companies when choosing between in-house manufacturing and CDMO partnerships, and much more.

  7. Harnessing AI and Synthetic Biology for Cell Therapies with Generate:Biomedicines' Dr. Alex Snyder 5/20/2025

    Host Erin Harris talks to Generate:Biomedicines' EVP of R&D, Dr. Alex Snyder on Cell & Gene: The Podcast about the convergence of AI, machine learning (ML), and synthetic biology in the development of next-generation therapies. They cover how AI is transforming drug discovery by enabling the rapid design and optimization of therapeutic candidates, particularly in complex fields like immuno-oncology and cell therapy.

  8. Hospital Systems & Complex Therapies With University Of Pennsylvania Health System's Kevin Mahoney 8/20/2021

    On this episode of Cell & Gene: The Podcast, University of Pennsylvania Health System’s CEO Kevin Mahoney talks to Host Erin Harris about how hospital systems must evolve to meet the needs of cell and gene therapy patients as these complex therapies are commercialized. They discuss what comprises UPHS and the ongoing innovation it brings to advanced therapies as well as how the Health System stays patient-focused at all costs.

  9. 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.

  10. Inside The World's First-Ever Allogeneic Approval With Atara Biotherapeutics' Pascal Touchon 3/30/2023

    In December 2022, Atara Biotherapeutics’ Ebvallo received European Commission approval as the first-ever therapy for adults and children with EBV+ PTLD. The ground-breaking approval represents the first approval of an allogeneic T-cell immunotherapy ever, globally. Atara Bio's CEO, Pascal Touchon, talks to Cell & Gene: The Podcast's Erin Harris about the biopharma's path to regulatory approval, commercialization plans for Ebvallo, an in-depth look at EBV+ PTLD, the connection between EBV and serious diseases like multiple sclerosis (MS), and much more.