Clinical Supply Manufacturing Articles

1. Inside GCSG 2026: Clinical Supply Impact On Patient Experience 5/21/2026

   This GCSG 2026 event recap with Steve Jacobs (including video) highlights how clinical testing and supply decisions shape patient experience, among other buzzy topics.

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. 4 Ways Academic Medical Centers Can Capture Greater Value In The Cell & Gene Therapy Industry 8/22/2023

   Academic medical centers (AMCs) are unique in the way academic functions and healthcare delivery services are co-located. With strong research capabilities, access to leading scientists, access to patients, and more, AMCs are uniquely positioned to conduct research and clinical trials, enable process development and manufacturing, and more.

4. If The CDMO Shoe Fits, Wear It Now 9/16/2024

   Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

5. Designing Highly Agile Bio/Pharma Manufacturing Facilities 4/5/2024

   In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules. 

6. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

   Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

7. 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.

8. Strategic Procurement For Emerging Pharmas & Biotechs 2/27/2023

   Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

9. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

   This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

10. How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials 10/25/2024

    Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.