Industry Insights

  1. Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains 6/19/2026

    Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.

  2. PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity? 6/19/2026

    Few topics introduced by Annex 1 have generated as much discussion as pre-use post-sterilization integrity testing (PUPSIT). I share key considerations for cell and gene therapies.

  3. Is Your AI Model Trustworthy And Credible In GMP Processes? 6/17/2026

    Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

  4. May 2026 — CDMO Opportunities And Threats Report 6/16/2026

    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.

  5. In Vivo Gene Editing Is Moving From Promise To Proof 6/15/2026

    CGT is shifting from technical promise to clinical execution as in vivo approaches reach an inflection point where delivery, durability, specificity, and manufacturability will determine whether the field can turn breakthrough science into safe, scalable, repeatable therapies.

  6. Why Improving Drug Delivery Remains A Major Opportunity In Oncology 6/12/2026

    Engineered oncolytic viruses are emerging as a promising way to target tumors, deliver immune-stimulating payloads, and improve treatment of metastatic cancer.

  7. FDA's Guidance On Cell And Gene CMC Codifies Flexibility 6/11/2026

    The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.

  8. Strategic Synthesis Of ASGCT And ASCO 2026 6/10/2026

    The spring 2026 conference season made one thing obvious to those of us watching the data: the artisan era of ex vivo cellular manufacturing is finally receding.

  9. Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality 6/8/2026

    Let's debunk the misconception that robotics, gloveless systems, or fully closed isolators automatically result in Annex 1 compliance for cell and gene therapies.

  10. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.