Guest Columns

1. Is Your AI Model Trustworthy And Credible In GMP Processes? 6/17/2026

   Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

2. May 2026 — CDMO Opportunities And Threats Report 6/16/2026

   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.

3. Setting The Tone For A Fill/Finish Engagement Program 6/15/2026

   The initial 90 days of a fill/finish CDMO partnership establish lasting communication patterns, clarify mutual responsibilities, and test problem-solving capabilities critical to program success.

4. FDA's Guidance On Cell And Gene CMC Codifies Flexibility 6/11/2026

   The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.

5. Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline? 6/10/2026

   Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.

6. Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality 6/8/2026

   Let's debunk the misconception that robotics, gloveless systems, or fully closed isolators automatically result in Annex 1 compliance for cell and gene therapies.

7. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

   Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

8. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

   This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

9. Managing Organic Impurities And Nitrosamines In APIs 6/4/2026

   How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.

10. AI Has Arrived In Biotech CMC Amid Patchwork Governance 6/3/2026

    AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.