Manufacturing

  1. CMC Developability Assessments For Rapid Ph.1 Entry With AltruBio's Gene Lee, Ph.D. 10/12/2021

    Fresh on the heels of an outstanding talk with AltruBio President & CEO Judy Chou, Ph.D., the company's VP of Technical Development, Gene Lee, Ph.D., joins the Business of Biotech for a deep dive into the importance of CMC developability assessments. On this episode we cover the key points CMC developability assessments must address, when to begin them, how to go about them efficiently, and why they're integral to early milestones and rapid entry into Phase 1 clinical trials.

  2. 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.

  3. Commercial Readiness with Orca Bio's Dan Kirby 9/14/2023

    Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing.

  4. Inhalable mRNA With Ethris' Carsten Rudolph, Ph.D. 2/1/2024

    Without doubt, the grand and collaborative experiment that was the mRNA COVID vaccine contributed mightily to the pandemic response and continues to save lives untold. It also demonstrated the collective power of public/private partnership in biopharma. 

  5. 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.

  6. 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.

  7. Cell Therapy Platform Dev With Precigen CEO Dr. Helen Sabzevari 3/29/2021

    Learn how Precigen is advancing a deep pipeline of immuno-oncology, infectious disease, and autoimmune disorder candidates through the clinic on the back of its UltraCAR-T platform. CEO Dr. Helen Sabzevari describes the promise of the platform to change the CAR T complexity paradigm with an overnight manufacturing process to affect patients in urgent need of timely therapy.

  8. Solving The COVID-19 Workforce Crisis 8/13/2020

    Obsidian Therapeutics CEO Dr. Paul Wotton didn't let pandemic-induced workforce restrictions impede his biopharma's progress. Instead, his team developed a software system purpose-built for biotechs to manage personnel and equipment per ever-changing guidelines. On this episode of The Business Of Biotech: Summer Executive Sessions, Wotton tells us how the application, dubbed SWIFT, was built, how it's working, and why Obsidian has made it available to more than 30 (and growing) other biotechs, free of charge.

  9. Regenerative Wound Care With BioStem Technologies' Jason Matuszewski & Andrew VanVurst 9/29/2022

    Here's the story of BioStem, its young founders, and how they reached commercial status in short order with a portfolio of proprietary regenerative wound care products developed from perinatal tissue. Fueled by a personal story of resilience and inspiration, Jason Matuszewski (CEO) and Andrew VanVurst (COO) built a company that's developed a local microenvironment activation platform drawing on a combination of small molecules, cytokines, and growth factors to promote tissue repair and regrowth. The company's internal development and cGMP manufacturing facilities have already yielded three approved products poised to change the paradigm for diabetic, traumatic, and other wound care.

  10. 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.