Manufacturing

1. Acepodia's Approach To ACC & CAR Manufacturing Scalability 1/19/2021

   Acepodia CEO, President, & Co-founder Dr. Sony Hsiao and Dr. Mark Gilbert, SVP of R&D, join Erin Harris and Matt Pillar for a discussion on the company's approach to dramatically reducing the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates.

2. Building A Better COVID Vaccine With Ocugen's Shankar Musunuri, Ph.D. 1/30/2023

   Is it past time for a new approach to the COVID vaccine? Ocugen Chairman of the Board, Founder & CEO Shankar Musunuri, Ph.D. says yes, and his ideals would mark significant improvements: fewer shots, better durability, less post-vaccination transmission, and safety proven by time-tested technology. How would such a vaccine be produced? Dr. Musunuri lays out the manufacturing science— and why the improved COVID vaccine his company is currently putting through Phase 2/3 trials makes good business sense—on this week's episode of the Business of Biotech. 

3. AAV & Lentiviral Gene Therapies With Sio Gene Therapies' Dr. Pavan Cheruvu 5/24/2021

   Fresh on the heels of a significant data readout on its AXO-AAV-GM1 candidate at the recent ASGCT meeting, Sio Gene Therapies CEO Pavan Cheruvu, M.D. joins the Business of Biotech podcast. We discuss Dr. Cheruvu's formative years and inspiration, his company's origins, its progress developing AAV and lentiviral gene therapies to treat GM1 gangliosidosis, Tay-Sachs / Sandhoff disease, and Parkinson's disease, and the challenges the company has overcome in a hybrid manufacturing environment that will ultimately transfer entirely in-house.

4. Propagating Peptides With Peptilogics' Jonathan Steckbeck, Ph.D. 5/24/2023

   Peptilogics CEO and founder Dr. Jonathan Steckbeck walks us through his transition from academic work into a clinical-stage company, how he's sustaining the company in a lean capital market, and more.

5. Manufacturing Partnership With Life Biosciences Jerry McLaughlin and Forge Biologics' John Maslowski 12/8/2024

   On this week's episode of the Business of Biotech, Jerry McLaughlin, CEO and President at Life Biosciences returns for a visit, and he brought a friend in John Maslowski, newly appointed CEO at Forge Biologics. We revisit progress at Life Biosciences, followed by a deep look into the gears that make the company's contract development and manufacturing relationship with Forge Biologics go.

6. Foundations Of Flexible Manufacturing With Sarepta Therapeutics' Brian Winstead 11/1/2021

   Is "flexible manufacturing" just another empty buzz concept concocted by the biopharma equipment marketing community, or does it demonstrate real benefit to bioprocess pros and their companies? On this episode, we sit down with Sarepta Therapeutics Director of Pharmaceutical Engineering Brian Winstead and Project Farma VP Tony Khoury to discuss what flexible manufacturing means, where it works, and where it doesn't. Listen in as Winstead shares the flexible manufacturing philosophy at Sarepta.

7. mAb Manufacturing with Rezolute Bio's Nevan Charles Elam, JD 4/5/2021

   Nevan Charles Elam, JD founded Rezolute Bio ten years ago on the heels of a complex career intersecting law, high tech, and life sciences. On this episode of the Business of Biotech, Elam shares the company's rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company's approach to process development and manufacturing.

8. In-Vivo CAR T Update With Umoja Biopharma's David Fontana, Ph.D. 11/28/2022

   2023 is just around the corner, and it's shaping up to be a big year for Umoja Biopharma. The company is on the leading edge of the effort to break the solid tumor barrier with in vivo CAR T-cell therapies, with one such effort currently enrolling patients for a phase 1 trial. It's planning two more INDs in the coming year. This episode of the Business of Biotech finds us getting the inside story from Umoja Chief Operating Officer David Fontana, Ph.D., whose storied career includes leadership positions at heavyweights including Sanofi, SeaGen, Pfizer, Juno, and BMS. Fontana shares on how he applies his experience playing a lead role in the success of Breyanzi, Adcetris, Bavencio, and Relatlimab in his new role at Umoja, the outsourcing battle scars that motivated the company to build its own 146,000 square foot development and manufacturing facility, and much more.

9. Gene Therapy Manufacturing At-Scale With Geoff MacKay 12/8/2020

   AVROBIO President & CEO Geoff MacKay tells the Business Of Biotech about the technology his company is using to drive at-scale gene therapy production for lysosomal disorders, replete with the story of how the company overcame a major manufacturing investment that didn't quite work as planned.

10. The Anti-CDMO with CTMC's Jason Bock, Ph.D. and KSQ's Thomas Leitch 5/19/2024

    This isn't your typical drug sponsor + CDMO story. In fact, CTMC's Jason Bock, Ph.D. says you shouldn't even classify his company as a CDMO. He's not wrong.