Featured Outsourcing Editorial

1. Why You Should Measure Comparability Debt Before Ever Starting A Study 9/17/2026

   When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.

2. What FDA Inspectors Want From Your OOS File 9/16/2026

   Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.

3. AI Fills The Decision-Making Gaps In Process Analytical Technology 9/16/2026

   When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.

4. You Can't CAPA What You Can't Classify 9/16/2026

   An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

5. Is mRNA Manufacturing Overbuilt? 9/15/2026

   mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.

6. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

   Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

7. Using Digital Platforms To Find Your CDMO 9/2/2026

   In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.

8. FDA Issues New Guidance On Therapeutic Equivalence 9/1/2026

   The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?

9. July 2026 — CDMO Opportunities And Threats Report 9/1/2026

   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. ADC CDMO Selection For Small Biotech 8/31/2026

    Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.