Guest Columns

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. Multispecific Trial Supply Stability Hinges On CDMO Agility 6/10/2025

   Naya's CEO describes the dynamics of producing a complex therapeutic for clinical trials on another continent, and how choice of CDMO plays heavily into that strategy.

6. The Promise And Challenges Of Cell-Free Protein Systems 6/10/2025

   CFPS use cell lysates or purified enzymes to synthesize proteins. They have emerged as a promising alternative to production with living cells.

7. 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.

8. 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.

9. 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.

10. Demystifying The Common Technical Document For Global Submissions 6/5/2025

    The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.