Manufacturing

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.