Featured Editorial

  1. What Did ICH Q14 Miss On Analytical Method Validation? 7/7/2025

    Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.

  2. June 2025 — CDMO Opportunities And Threats Report 7/3/2025

    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.

  3. Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices 7/3/2025

    Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

  4. Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification 7/1/2025

    A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

  5. How CGT Leaders Are Reducing Failures, Scaling Processes, And Overcoming Regulatory Friction 6/30/2025

     Industry leaders share their philosophy on reducing product failure, embracing AI, and building dynamic teams to stay ahead of the curve to bring curative CGT therapies to patients.

  6. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

    Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

  7. Why 'Which Is Best?' Is The Wrong Question In CGT Development 6/27/2025

    In cell therapy development, the instinct to seek a single “best” option is natural — but in reality, there’s rarely a universal winner.

  8. Finding Compatibility In Love And CDMO Partnerships 6/26/2025

    Just like people, some sponsor-CDMO partnerships can be matches made in heaven. Others, not so much. See what experts have to say about finding the right CDMO and building a successful partnership together.

  9. Five Takeaways from BIO 2025 and Why You Should Stay Tuned 6/26/2025

    New chief editor of Drug Discovery Online shares insights from BIO 2025’s global biotech gathering and spotlights the impacts to early-stage drug research.

  10. Lonza Bets On Biologics. What's It Mean For You? 6/26/2025

    It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” including for antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry?