Manufacturing

  1. 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.

  2. The Promise Of Genome Editing With Caribou Biosciences' Rachel Haurwitz, Ph.D. 8/15/2023

    On this episode of Cell & Gene: The Podcast, Rachel Haurwitz, Ph.D., CEO at Caribou Biosciences joins Host Erin Harris to discuss the evolution of genome editing, its present state, as well as its undeniable potential. Listen now to learn more about Caribou's chRDNA genome editing technology and how it differs from CRISPR-Cas9.

  3. 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.

  4. 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.

  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. Inside RNAi With Arrowhead Pharmaceuticals' Javier San Martin 9/29/2022

    Arrowhead Pharmaceuticals is a biopharmaceutical company based in Pasadena, CA that develops medicines that treat intractable diseases by silencing the genes that cause them. Javier San Martin, Arrowhead's CMO, talks to Cell & Gene: The Podcast listeners about the similarities and differences between RNAi and CRISPR. He also explains the roadmap for RNAi as well as the company's pipeline development strategy, which includes pre-clinical to Phase 3 trials.

  7. Best Practices For Partnering With A CDMO 8/9/2022

    Emily Moran, VP of Vector Manufacturing and Avi Nandi, VP of Process Development at the Center for Breakthrough Medicines share key considerations on Cell & Gene: The Podcast for biotechs looking to partner with a CDMO. Learn how to reduce risk, lower costs, and better manage expectations when it comes the biotech/CDMO relationship.

  8. 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.

  9. Building Integrated cGMP Systems for Autologous Cell Therapies with MassGen's Tatyana Matveeva, Ph.D. 5/6/2026

    In episode 128, Host Erin Harris talks to Tatyana Matveeva, Ph.D., Director of cGMP Operations at George A. "Doc" Lopez, MD Laboratory for Regenerative Cell Therapy, Harvard Medical School and Massachusetts General Hospital, about leading cGMP operations within an integrated ecosystem at Harvard Medical School and Massachusetts General Hospital, where manufacturing, research, and neurosurgery coexist.

  10. 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.