Editorial Perspectives On Cold Chain

  1. Flexible Manufacturing & Single Use: A Story Of Love And Hate 12/6/2021

    Flexible biopharma manufacturing facilities and the single-use tech that supports them are in vogue, fueled by a groundswell of clinical-stage advanced therapies and the need for speed to advance them. Sarepta’s Brian Winstead shares the ups and downs of the approach at Sarepta Therapeutics.

  2. Cell Therapy Logistics: Challenged By COVID-19 8/18/2021

    Kite Pharma was in the midst of a global cell therapy manufacturing expansion initiative when the first wave of the COVID-19 pandemic hit. This conversation with Charles Calderaro covers challenges faced scaling cell therapy manufacturing and accessibility worldwide and how Kite is developing competitive advantage in a nascent space.

  3. Cell Therapy Production To Clinical Administration: Addressing The Gap 7/9/2021

    Cell therapy manufacturing teams and cell therapy clinicians aren’t talking to each other, and when they do, they’re often speaking different languages. What’s the industry doing to fill the gap between therapeutic production and clinical administration, and what kind of talent does it require?

  4. Beating Herpes: Inside X-VAX's Vaccine Candidate 5/18/2021

    An inside look at preclinical stage biotech, X-VAX, which is preparing to engage the FDA with data on an HSV vaccine candidate that could have therapeutic impact on a virus carried by the majority of the world’s population. 

  5. Decentralized Cell Therapy Production In Practice 4/21/2021

    Distributing the manufacture of autologous cell therapies to clinical and hospital settings to minimize time, cost, and logistics challenges is a popular conversation in biopharma circles. While many discuss it, Dr. Helen Sabzevari’s upstart biopharma Precigen is doing it.

  6. $2,000-Per-Dose Cell Therapy In The Clinic 2/12/2021

    With its ongoing Phase 1 clinical trial of ACE1702 for the treatment of HER2-expressing solid tumors, Acepodia founder, CEO, and president, Sonny Hsiao, Ph.D. and SVP of R&D, Mark Gilbert, M.D., make a case for fast, affordable, and effective off-the-shelf cell therapies.

  7. The Real Threat To Biopharma Supply Chains: Bioprocessing Materials 5/12/2020

    The COVID-19 induced risk to biopharma is not a shortage of pharmaceutical ingredients. It’s the constricting supply of consumable materials and equipment necessary to produce therapies from them. Mike Piccarreta, Partner at Kearney, offers an outlook and practical advice on supply stabilization in this BioProcess Online exclusive. 

  8. New FDA Guidance For Clinical Trials Disrupted By COVID-19 3/19/2020

    During this unprecedented time full of unanticipated challenges for biopharmas, FDA has issued new guidance that offers advice on adjusting clinical trial protocols in the midst of the fast-spreading and ill-understood virus SARSCoV-2 and its resulting COVID-19.

  9. Why EU's New Med Device Regs Matter To Biopharma 10/4/2019

    Pharma's CMC regulatory affairs staff, R&D leadership, manufacturing, quality and compliance professionals take note: the EU MDR is real, it becomes effective next May, and it brings with it new challenges and regulatory uncertainty for manufacturers of combination products.     

  10. AbbVie's Dr. Howard Jacob: Improving The Drug Pipeline With Genomics 8/21/2019

    The relationship between therapies and genetic composition is incredibly important to the future of medicine, and the way it's manufactured. I sat down to discuss the topic with Dr. Howard Jacob, who's working to improve the drug pipeline at AbbVie using genomics tools.