Contributing Editors

1. 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.

2. 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.

3. 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.

4. 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.

5. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

   The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

6. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

7. Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms 6/5/2025

   Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

8. May 2025 — CDMO Opportunities And Threats Report 6/4/2025

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

9. The Matryoshka Model: The New Face Of Contract Packaging In Pharma 6/4/2025

   Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

10. A Road Map For Transitioning From A Research-Focused To Commercialization Mindset 6/3/2025

    As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?