Manufacturing

  1. A Hybrid mAb Manufacturing Model With John Glasspool 1/30/2022

    Post-operative venous thromboembolism (VTE) is a serious and prevalent post-operative risk that has several contributing factors. John Glasspool, CEO at Anthos therapeutics, is on a mission to address the issue—and a host of other cardiovascular and metabolic conditions—with monoclonal antibodies that inhibit coagulation Factor XI and its activated form XIa. On this episode of the Business of Biotech, Glasspool discusses the advantages and challenges of the hybrid manufacturing approach at Anthos, and how its strategy has enabled phase 1 and 2 clinical studies that have demonstrated an 80% reduction of the rate of VTE in post-operative total knee arthroplasty patients compared to the standard of care (enoxaparin).

  2. 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.

  3. 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.

  4. 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. 

  5. 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.

  6. 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.

  7. Complete CAR T Manufacturing Control with Cellectis' Steve Doares 12/20/2021

    Cellectis' decision to build and operate its own trans-Atlantic manufacturing facilities was a strategic one. On this week's episode of the Business of Biotech, SVP of U.S. Manufacturing Steve Doares talks internal manufacturing rationale, discusses interoperability between its Paris and Raleigh, N.C. plants, and shares how the company keeps meeting the challenges presented by COVID-fueled supply chain disruptions head-on.

  8. Women In Biotech With Bill & Melinda Gates MRI's Piper Trelstad, Ph.D. 1/16/2023

    After more than 21 years leading process, product, and technical development efforts at Merck and Takeda, Piper Trelstad, Ph.D. joined the Bill & Melinda Gates Medical Research Institute (MRI) in January 2022. On this episode of the Business of Biotech, we'll dive into how the MRI, a full-fledged clinical-stage biopharmaceutical company, is tackling health problems that challenge some of the world's most vulnerable populations. Dr. Trelstad also shares her minority perspective as a woman working in a highly technical capacity in biopharma, and how the industry can proactively support and advance women in technical roles.

  9. 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.

  10. 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.