Clinical Supply Manufacturing Articles

1. Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making 2/27/2025

   The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

2. Boosting Pipeline Acceleration With A Strategic Pharma/CDMO Relationship 3/25/2022

   Pharma portfolio managers and CDMOs should seek more strategic modes of working together. By coordinating with each other to change all your development and capacity "red lights" to green, and balancing operational efficiency and flexibility, you can accelerate your pipeline. Here's how.

3. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

   Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

4. FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

   This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.

5. AstraZeneca's Digitally Connected Strategy For API Manufacturing 12/3/2024

   The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.

6. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

   Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

7. 5 Benefits Of Using MES For Cell & Gene Therapies 12/20/2024

   Cell and gene therapies have unique complexities and challenges. A manufacturing execution system (MES) can expedite your processes and get your product to commercialization faster.

8. What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production 3/8/2024

   Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.

9. Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies 1/17/2025

   Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

10. When Should You Select Your Supply Partner? 9/19/2024

    In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.