Industry Insights

  1. Arcellx On Designing A Dynamic CAR-T 3/13/2025

    Arcellx's CMO and CTO talk about the company's platform technology, its partnership with Kite, and preparing its lead asset, anito-cel, for commercial launch.

  2. Are CDMO Partnerships The Answer To Manufacturing Capacity Issues? 3/13/2025

    The current manufacturing strain is exacerbated by factors such as the intensity of scaling up fill-finish and specialized manufacture of drug delivery devices. How can partnering with a CDMO help?

  3. MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs 3/11/2025

    The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.

  4. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

    Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

  5. AI Performance Management In Biologic And Drug Development 3/7/2025

    Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.

  6. Mesenchymal Stem Cells Hold The Key To Treating Degenerative Conditions 3/7/2025

    Mesenchymal stem cells offer a promising path forward in managing complex conditions that are often age-related. What makes MSCs unique and how do they compare to iPSCs?

  7. February 2025 — CDMO Opportunities And Threats Report 3/7/2025

    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.

  8. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

    Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

  9. 4 Key Steps To Build Supply Chains For Later-Stage Clinical Trials In LMICs 3/6/2025

    Gates MRI's head of clinical supply discusses learnings and considerations that he keeps in mind for clinical trial supply chain/logistics.

  10. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

    The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.