Manufacturing

31. The CDMO Capacity Crunch ft. Discovery Labs' Audrey Greenberg And Iovance Biotherapeutics' Sumit Verma 10/27/2021

    While nary a day goes by without a shovel breaking ground on a new CDMO buildout, biopharmas remain hard-pressed to secure the outsourced manufacturing space and expertise needed to meet timelines, satisfy investors, and drive competitive advantage. On this episode of the Business of Biotech, we're tackling the CDMO capacity crunch from every angle in a spirited discussion with Discovery Labs & Center for Breakthrough Medicines Co-Founder Audrey Greenberg, Iovance SVP of Commercial Manufacturing Sumit Verma, and Project Farma CEO Anshul Mangal.

32. CAR T Process Automation With Kite Pharma's Charles Calderaro III 7/12/2021

    Kite Pharma Global Head of Technical Operations Chuck Calderaro joins the Business of Biotech for a conversation on a dichotomy in the CAR T-cell supply chain: the inherent source material advantages and subsequent logistical challenges associated with the distribution of cell therapies. Calderaro discusses the implementation of manufacturing automation at Kite, the manufacturing hurdles that remain, and reflects on the company's autologous and allogeneic roadmaps.

33. 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.

34. A More NIIMBL Biotech Workforce With John Balchunas 5/4/2023

    What are biopharma's greatest skilled manufacturing labor needs, and what's the industry doing to fill them? John Balchunas is on the front lines in his position as Workforce Director at NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals, and he says advanced degrees and pedigrees aren't the answer. The breadth and depth of NIIMBL's efforts to influence the next generation of the biopharma workforce — from high school vocational programs to community colleges and on-the-job development—might surprise you. Listen in as Balchunas brings the Business of Biotech up to speed on a training and development agenda that plants seeds early and often.

35. A Scale-Up Story With Solis BioDyne Drs. Kadri Artma And Angela Vaasa 6/29/2021

    When the pandemic hit, Solis Biodyne found its manufacturing capacity stretched to the limit. In short order, it doubled, and then tripled, its manufacturing capacity. Then it doubled, and then tripled, its workforce. Meanwhile, it adopted a host of new platforms to serve the demand of its clients. Drs. Kadri Artma and Angela Vaasa join this episode of the Business of Biotech to take us behind the scenes and tell us the scale up story that's allowing the renowned producer of reagents to the life sciences industry to meet market demands.

36. Observations On Outsourcing With Molecule To Market's Raman Sehgal 8/15/2022

    Raman Sehgal has made a career out of putting his energy— and he's got a lot of it— into building biotech outsourcing companies and the people who make them run. After years spent supporting several from within, he launched ramarketing, a firm dedicated to helping CROs, CDMOs, CPOs, and other providers to the biotech ecosystem build their businesses, in 2009. He's also an international best-selling author (The Floundering Founder), co-founder of life sciences recruitment firm Lead Candidate, and founder & host of the Molecule to Market podcast.

37. 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. 

38. NK Cell Therapy Accessibility With Shoreline Biosciences' Dr. Kleanthis Xanthopoulos 2/6/2022

    Shoreline Biosciences CEO Kleanthis Xanthopoulos, Ph.D. joins the Business of Biotech to share the company's strategy for the development, manufacture, and commercialization of off-the-shelf NK (natural killer) cell therapy. On this episode, Dr. Xanthopoulos shares why the cell and gene immunotherapeutic market has underperformed to date, why he believes autologous is not the long-term path forward, and the safety and accessibility advantages he sees in his allogeneic-based, pluripotent stem cell approach. 

39. 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.

40. 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.