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. 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,

  3. The Future Of Cell And Organ Transplantation In Treating T1D With Dr. Camillo Ricordi 10/10/2023

    Explore the biggest and most troubling challenges facing the treatment of Type 1 Diabetes (T1D) and the future of cell and organ transplantation in treating T1D as well as the latest innovations in biopreservation.

  4. The Future Of iPSCs With BlueRock Therapeutics' CEO Seth Ettenberg 12/8/2022

    BlueRock Therapeutics' President and CEO Seth Ettenberg, Ph.D. talks to Cell & Gene: The Podcast listeners about the company's Phase 1 Clinical Trial for Advanced Parkinson’s Disease. Ettenberg also covers the most promising therapeutic applications for iPSCs currently in development as well as the major regulatory challenges that the field faces for their clinical use. We also cover how far iPSCs have come and what future progress may entail.

  5. 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.

  6. 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.

  7. The Future of Tissue-Based Therapies 7/8/2021

    Enzyvant's CEO, Rachelle Jacques, explains the company's lead asset, the roadmap for tissue-based therapies, and more.

  8. 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.

  9. 2023 Market Outlook with AdBio and ISCT's Miguel Forte 2/2/2023

    Miguel Forte is Entrepreneur in Residence at AdBio, a VC firm based in France, and President Elect of ISCT. Forte and Cell & Gene: The Podcast host, Erin Harris, break down market outlook perspective for the cell and gene therapy space. He provides valuable tips to employ when seeking VC partnership, and he covers ISCT's primary focus areas and what to expect from ISCT 2023 Paris.

  10. State-of-the-Art GMP Manufacturing RNA Cell Therapies With Cartesian's CEO 8/19/2021

    Dr. Murat Kalayoglu, CEO at Cartesian Therapeutics, details the cell and gene therapy sector's advancements in RNA cell therapy and the why behind the company's decision to build its own wholly-owned GMP manufacturing facility.