Featured Bioprocessing Editorial

  1. AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence 6/23/2025

    Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management. 

  2. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

    Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

  3. Ask The Pros — The Latest In Downstream HCP Mitigation 6/20/2025

    Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.

  4. How Is RIM Software Transforming Regulatory Compliance? 6/20/2025

    Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

  5. Draft EMA Doc Proposes More Flexibility On Biosimilar CES Requirements 6/19/2025

    Clinical efficacy studies may not be necessary under certain conditions, writes the European Medicines Agency in a new draft reflection paper.

  6. Exploring The Market For Closed-Loop Cell Therapy Production 6/18/2025

    The second part of a discussion on closed-loop systems explores the CDMO and equipment landscape for scaling automated closed loop cell therapy manufacturing systems.

  7. Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need 6/18/2025

    In cell therapy manufacturing, automated closed systems with integrated software controls offer numerous benefits over traditional open systems.

  8. What Global Survey Says About Scant Patient Access To CAR-T Therapy 6/17/2025

    The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.

  9. Scaling Up Manufacturing? Here's Why You Need A CMC Specialist 6/16/2025

    CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

  10. Amgen Bets On Agility In The Age Of AI 6/13/2025

    The company is speeding up process optimization with tools like predictive analytics, digital twins, and generative AI copilots.