Guest Columns & From The Editor

81. 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

82. 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.

83. 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.

84. 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.

85. 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.

86. 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.

87. 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.

88. Navigating Data Management Requirements For Sterile Manufacturing 6/11/2025

    Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.

89. The Promise Of Focused Ultrasound For AAV Gene Therapy Delivery 6/11/2025

    Dr. Bernie Owusu-Yaw, a research fellow at Brigham and Women’s Hospital and Harvard Medical School, is pioneering a promising gene therapy approach that combines focused ultrasound with novel AAV capsids to safely and effectively deliver therapeutics across the blood-brain barrier, offering new hope for treating challenging neurodegenerative diseases.

90. A Guide To Designing mRNA Medicines 6/10/2025

    A poorly designed mRNA sequence can create ongoing difficulties during downstream clinical development and manufacture. Let's take a closer look at strategies and design software that you can employ.