Guest Columns

1. High Specific Productivity For Leaner Sustainable Bioprocessing 1/30/2026

   Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.

2. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

   International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

3. Facility Considerations When Retrofitting Legacy Sites For ADCs 1/26/2026

   Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

4. In Vivo's Biggest Threat — Comparison To Old Models 1/23/2026

   In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

5. Managing Supply Chain Risk In Scale-Up And Multisite Trials 1/23/2026

   Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.

6. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

   The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

7. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

   Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

8. Global Clinical Supply — Confronting Persistent Challenges With Strategic Action 1/21/2026

   From regulatory fragmentation to cold chain risks, discover how strategic action, data visibility, and resilient design keep clinical trials on track.

9. December 2025 — CDMO Opportunities And Threats Report 1/20/2026

   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.

10. Do's And Don'ts Of Material Handling When Retrofitting For ADCs 1/20/2026

    Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.