BIO From The Editor and Guest Columns

  1. Developing A Viral Gene Therapy Manufacturing Process 1/23/2024

    There is a growing popularity of adeno-associated virus (AAV) for delivering in-vivo gene therapies, a growing preference of transient transfection systems by biologics companies, and an increasing number of CDMOs offering this system as a platform process. This article describes a transient transfection AAV manufacturing process that uses a triple plasmid transfection strategy into HEK293T cells.

  2. Tracking 4 Payload Trends In Drug Delivery Development 1/22/2024

    Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.

  3. A New Year’s Resolution Suggestion For The FDA 1/22/2024

    Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.

  4. Multimodal R&D Management With Incyte's Jim Lee, M.D., Ph.D. 1/21/2024

    Success at multimodal, multi-indication, deep-pipelined Incyte—where commercial operations are as familiar as pre-discovery activity is—begins at the earliest opportunity to achieve research and discovery efficiencies. 

  5. Building A Biotech Hub With Intellia Therapeutics' John Leonard, M.D. 1/14/2024

    We spend a lot of time talking with our guests about building biotech companies. That’s true of this episode too, but today we’re taking a step further with John Leonard, M.D., longtime CEO at Intellia Therapeutics. In addition to how he’s built late-clinical stage Intellia, Dr. Leonard shares the foundational elements of a biotech community, particularly around rapidly-advancing technologies such as CRISPR, and what biotech ecosystems offer emerging biotechs in terms of resources, intellectual property, and support.

  6. Need To Improve Your Change Management? Regulators Can Help With That 1/12/2024

    The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.

  7. Is FDA’s COVID Container Closure System Guidance Useful Post-Pandemic? 1/9/2024

    The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.

  8. Are Single-Use Technologies Always The Answer? 1/9/2024

    It is clear that single-use technologies (SUTs) have won the war over reusable stainless steel. However, beneath the surface, there is a web of considerations that challenge the belief that SUTs are unequivocally cost-effective. Let's look at cost considerations as well as risk considerations.

  9. Cell & Gene Therapies: How Can Our Knowledge Of 2023 Inform Our Predictions For 2024? 1/8/2024

    2024 promises a potential turnaround and blue skies for cell and gene therapies. Let’s explore each modality’s prospects: oligos and mRNA, cell therapies, and viral gene therapies.

  10. Art Of The Pivot With Elevation Oncology's Joe Ferra 1/7/2024

    Relatively new CEO Joseph Ferra has orchestrated some pretty significant change at Elevation Oncology in the two(ish) years since the Business of Biotech last hosted the company. In that short time, Ferra advanced from CFO to CEO, a move that aligned very closely with the company's difficult decision to shelve the late phase 2 anti-HER3 monoclonal antibody candidate it was founded on.