Industry Insights

  1. The Real Reason We Haven't Fully Automated Cell Therapy Yet 2/26/2026

    Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.

  2. Process Engineering's Key Role In Sterile Injectable Facility Design 2/24/2026

    Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

  3. What To Know About — And How To Apply For — FDA's PreCheck Pilot 2/23/2026

    FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.

  4. Breaking Through Tumor Defenses With Next-Generation Cell Therapy 2/20/2026

    Ernexa Therapeutics CEO Sanjeev Luther shares how clinical research has revealed why certain cancers resist treatment and how emerging cell therapies may help break through those defenses.

  5. MES Is Still In The CD ROM Era But The Data Architecture Has Moved On 2/20/2026

    Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

  6. Inside Mesoblast's Playbook For Making Allogeneic Cell Therapy Real 2/18/2026

    Mesoblast's Silviu Itescu shares how two decades of rigorous science and manufacturing turned allogeneic MSCs into the first FDA-approved cell therapy while building a scalable platform for inflammatory diseases such as GvHD, back pain, and heart failure.

  7. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

    Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

  8. Not So Fast Into The Night: Your Outsourcing Needs A Pause 2/16/2026

    Barreling through the initial months of the year? Here’s a suggestion from Chief Editor Louis Garguilo to pump the breaks for a bit. Take one more glance in the rearview mirror to assess your current progress, reconfirm your pathway is your intended one. An outsourcing pause might pay off handsomely this year, and that’s because a lot happened last year on the supply-chain front. You made plans and formed expectations based on those trends and experiences. Are you currently abiding by those analyses? 

  9. Active Versus Passive Shipping Solutions For Clinical Shipments 2/13/2026

    Explore active and passive temperature-controlled shipping solutions and their impact on clinical trial supply, balancing cost, risk, and product integrity.

  10. January 2026 — CDMO Opportunities And Threats Report 2/12/2026

    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.