Clinical Supply Manufacturing Articles

1. 3 Strategies For mAb Manufacturing: How Do You Choose? 3/19/2025

   As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.

2. What's A “Hybrid Externalized” Manufacturing Model? 3/10/2022

   Anthos Therapeutics’ phase 2 antibody candidate abelacimab could dramatically improve the way clinicians treat very common, high-risk arterial and venous thromboembolic events. The company is exercising manufacturing creativity to maintain clinical supply. Anthos CEO John Glasspool shares on the Anthos approach to outsourcing. 

3. 7 Steps To Accelerate Biopharma Manufacturing Processes 5/21/2024

   Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.

4. 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?

5. 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.

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 FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

   This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.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

7. 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.

8. When In The Product's Life Cycle Does Continuous Manufacturing Make Sense? 2/1/2024

   This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.

9. Strategizing The Scale-Up Of Cell Therapy Manufacturing Capacity 4/19/2023

   Adaptimmune’s Mike Blankenstein, vice president of patient supply operations, discusses the team's manufacturing network strategy designed to evolve with them as the company grows from clinical to commercial supply needs, balancing cost and risk, while ensuring flexibility to respond to patients’ needs.

10. 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.