Manufacturing

1. Product Vs. Platform With Surface's Vito Palombella, Ph.D. And Robert Ross, M.D. 11/6/2022

   Earlier this month, Surface Oncology shared that it will open a second stage of its monotherapy trial of SRF388, an antibody targeting IL-27, on the heels of a promising phase 2 data readout. Shortly before that release, the Business of Biotech caught up with Surface's CSO Vito Palombella, Ph.D. and CEO Rob Ross, M.D. in the company's Cambridge, MA HQ. We discussed the first-of-its-kind target, the company's "product versus platform" strategy and how it fits in the industry's current "platform" vibe, the finer points of building and maintaining a startup bio culture, the difference between that Bob Ross and the Rob Ross, M.D., and whole lot more. 

2. 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.

3. Orchard Tx's Bobby Gaspar On Manufacturing Hematopoietic Stem Cells 1/25/2021

   In this third installment of our cell & gene therapy manufacturing miniseries, Erin Harris and Matt Pillar sit down with Orchard Therapeutics CEO Dr. Bobby Gaspar. An update on the company's pipeline progress gives way to an in-depth discussion on the process challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders.

4. Gene Therapy Manufacturing Advances With Aruvant CTO Dr. Palani Palaniappan 9/7/2021

   Aruvant Chief Technology Officer Palani Palaniappan, Ph.D. joins the Business of Biotech with special guest Tony Khoury, EVP at Project Farma to discuss recent advances in gene therapy manufacturing. We cover the role of artificial intelligence in the discovery of AAV capsids that can avoid the immune system, the growth of non-viral vectors, the scale up advantages of suspension technologies versus adherence, the evolution of the regulatory environment, manufacturing capacity and talent constraints, and much, much more.

5. Commercial Readiness with ImmunityBio's Bobby Reddy, M.D. 4/14/2024

   This episode of the Business of Biotech begins with a personal story about my dad and the standard of care in bladder cancer, before shifting to the work that Dr. Bobby Reddy and his team at ImmunityBio are doing to change that standard of care. They're painfully close. Dr. Reddy, Chief Medical Officer at ImmunityBio, gives us a long look behind the curtain at the commercial preparations the company is making as its lead Phase 3 candidate, Anktiva, nears the goal line in non-muscle invasive bladder cancer (NMIBC). 

6. 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.

7. 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.

8. Inflammation & Antibodies With Ampio Pharmaceutical's Mike Martino, CEO 6/1/2022

   Ampio Pharmaceuticals is currently weaving the gauntlet of a clinical hold triggered by COVID's disruption to clinical studies of its lead candidate Ampion, and recently launched an independent investigation into that trial and others. On this episode. Ampio Pharmaceuticals chairman and CEO Mike Martino joins the Business of Biotech for a candid discussion on the company, the candidate, the disruption, and the go-forward plan. 

9. Building LEO Pharma's U.S. Presence with Brian Hilberdink 8/23/2023

   In many respects, bringing an established foreign biopharma company to the U.S. market is not unlike starting one up from scratch. In other respects, it's even harder. The job's not for the faint of heart, which might be why the Danish company LEO Pharma tapped veteran biopharma leader Brian Hilberdink to lead its U.S. operations.

10. Cornering The Antibody Market With Akesobio CEO Dr. Michelle Xia, Ph.D. 11/23/2021

    In business for just a decade, Akesobio's stats are mindboggling: 20 drug development programs, including 12 antibodies in clinical-stage development, six bi-specific antibodies (two at clinical stage), four antibodies with IND approvals from the FDA, and 22 clinical trials initiated. The company's CEO, Michelle Xia, Ph.D., sat down with the Business of Biotech for a conversation about how the company has managed such supercharged growth.