Industry Insights

  1. 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.

  2. 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.

  3. 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies 7/3/2025

    The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

  4. Pushing The Boundaries In Cell Therapy: CAR-T Updates From EHA 2025 7/2/2025

    The 30th European Hematology Association (EHA) Congress in Milan highlighted a more mature CAR-T therapy landscape, where rapid manufacturing, durable responses, and improved safety profiles are converging.

  5. Inside AviadoBio And Astellas's Shared Mission To Bring Gene Therapy To Patients With FTD-GRN 7/2/2025

    AviadoBio and Astellas have joined forces to advance an investigational gene therapy designed to treat frontotemporal dementia with progranulin mutations (FTD-GRN), aiming to address a critical unmet need in neurodegenerative disease.

  6. 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.

  7. 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.

  8. 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.

  9. Understanding FDA's New National Priority Voucher Pilot Program 6/25/2025

    The FDA's vouchers will be issued to companies addressing health issues in the U.S. and increasing domestic manufacturing, among other criteria.

  10. The Latest Techniques And Technology For Differentiating Capsids 6/24/2025

    Since AAV gene therapy’s origins, scientists and regulators have sought optimized ways to measure empty/full capsids. This expert reviews pros and cons of modern methods.