Featured Outsourcing Editorial

  1. 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.

  2. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

    The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

  3. Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet 6/19/2025

    This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Peeling Back The Layers Of Radiolabeled Peptide Production 6/12/2025

    From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.

  10. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.