Cell and Gene Regulatory

  1. FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing 4/22/2026

    The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

  2. When CGT Supply Chains Break Down: 5 Operational Gaps That Put Patient Outcomes At Risk 4/22/2026

    Examine five of the most consequential gaps in CGT supply chain performance and learn what high-functioning teams do differently to protect patient outcomes before a failure occurs.

  3. Cytotoxicity: How To Provide Operator Safety 4/22/2026

    ADC payloads active at nanogram concentrations create serious operator safety risks. Here is what manufacturers must get right to protect operators across every stage of production.

  4. Validating Candel's BLA-Ready Analytics Profile 4/22/2026

    The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.

  5. Mapping Candel Therapeutics' Sprint To The BLA Finish Line 4/22/2026

    Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.

  6. Safeguarding Biologic Integrity Through Enhanced Component Compatibility 4/21/2026

    For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

  7. Optimizing Syringe Performance For Reliable Drug Delivery 4/21/2026

    Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.

  8. Maintaining Sterility Through Precise Component Design And Manufacture 4/21/2026

    Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.

  9. Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems 4/20/2026

    Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.

  10. Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution? 4/20/2026

    Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.