Industry Insights

  1. A Study In Optimizing Late-Stage Processes With QbD, DoE 9/26/2025

    Nobody wants to redesign analytical process profiles when a market approval is within reach, but what about when a last-lap QbD exercise could bring real benefit?

  2. On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D. 9/25/2025

    DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.

  3. Key Considerations For Materials And Components Used In CGT Manufacturing 9/25/2025

    This article sheds light on the complexities and regulatory intricacies of ancillary materials and single-use systems in cell and gene therapy manufacturing.

  4. Defining Strong Program Management In CDMO Partnerships 9/23/2025

    This first article of a planned three-part series discusses the pitfalls that program managers help sponsor companies avoid, how program managers accelerate timelines or reduce risk, and more.

  5. CGT Success Starts With The First Mile 9/23/2025

    The so-called "last mile" in cell therapy gets a lot of attention. What about the first mile, the journey cells take between the donor and the manufacturing site?

  6. Making The Leap To Smart Bioprocessing 9/19/2025

    A European consortium achieved greater T cell expansion compared to baseline conditions using real-time process monitoring and control.

  7. Unlocking Method Insights For Novel Engineered AAV Capsids 9/18/2025

    Microfluidic platforms, such as labchip, are widely used for assessing wild type capsids. Now, engineered capsids are challenging these established workflows.

  8. Manufacturing Interleukin-2 For In Vivo Use: Key Considerations 9/16/2025

    Interleukins help optimize therapeutic outcomes in cancer immunotherapy and regenerative medicine. Manufacturing success requires stringent control over production, formulation, and stability to ensure safety and efficacy.

  9. Sanofi's Digitalization Road Trip Shifts Into High Gear 9/16/2025

    The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

  10. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

    Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events.