Cell and Gene Regulatory

  1. Material Transfer Into A Cleanroom: How To Reduce Contamination Risk At Every Step 4/20/2026

    Evaluate packaging integrity and master wiping techniques to prevent cleanroom contamination. Focus on surface coverage and controlled transfer paths to ensure consistent product safety and quality.

  2. Addressing A Critical Drug Shortage 4/20/2026

    A critical drug shortage demanded regulatory action, importation support, and patient program readiness. See how integrated QA, 3PL, and PSP capabilities delivered operational readiness in three months.

  3. Foreign Action Notification To Health Canada 4/20/2026

    Health Canada is tightening foreign action reporting expectations. MAHs need to understand what the updated draft guidance means for their compliance and monitoring processes now.

  4. An Integrated, Verified PFS System For Vaccines 4/20/2026

    A pre-verified delivery platform eliminates redundant testing, simplifies regulatory submissions, and optimizes inventory management, allowing teams to focus on drug-specific performance.

  5. Freeze Your Device Design With An Integrated, Verified PFA System 4/20/2026

    Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.

  6. The Evolving Landscape Of HPAPI Contract Manufacturing 4/20/2026

    Surging demand for highly potent drugs is driven by targeted therapies, stricter containment standards, increased outsourcing, and the need for specialized, compliant manufacturing.

  7. Achieving Inspection-Readiness For Cell Sorters And Analyzers 4/17/2026

    Inspection‑readiness depends on consistency and control. Explore strategies for standardizing cell sorting workflows, minimizing variability, and using electronic records to support compliance.

  8. The Impact Of FDA Risk On Biotech Rewards With CFO And Board Director Allan Shaw 4/16/2026

    On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and how that uncertainty is reshaping clinical trial strategy, investor behavior, and the innovation ecosystem.

  9. Quality By Design For Outsourced Operations 4/16/2026

    A practical guide to applying Quality by Design to outsourced GXP operations, helping virtual and hybrid sponsors maintain regulatory control, inspection readiness, and accountability.

  10. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.