Cell and Gene Regulatory

  1. Fast Track NAT-Based Mycoplasma And Spiroplasma Testing Using dPCR 1/14/2026

    Modern digital PCR testing provides rapid, highly sensitive detection of over 124 species, ensuring global regulatory compliance and protecting short shelf-life products.

  2. The Growing Case For AI To Support Pharmacovigilance 1/14/2026

    Insights from the World Drug Safety Congress reveal how automation and AI streamline signal management and safety reporting while maintaining essential human oversight and ensuring regulatory compliance.

  3. Data Governance And Regulations For AI Use In GMP With Peter Baker 1/13/2026

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Peter Baker, former FDA investigator and president of Live Oak Quality Assurance.

  4. Enhanced Flow Kit Performance With Leak And PUPSIT Testing 1/13/2026

    Sterile drug filtration demands rigorous integrity testing to prevent contamination. Learn how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.

  5. Automated PUPSIT For Drug Product Applications 1/13/2026

    Automated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.

  6. Single-Use Standards Are Maturing, But The Process Remains King 1/13/2026

    The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.

  7. Wetting Recommendations For Successful Filter Integrity Testing 1/12/2026

    Discover best practices for hydrophobic and hydrophilic filters, troubleshoot failures, and optimize wetting in stainless steel and single-use systems to ensure process reliability and product quality.

  8. Why Choose Robotic Processing For Small Batch Aseptic Filling 1/9/2026

    Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.

  9. Key Topics And Trends In Aseptic Filling 1/9/2026

    Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.

  10. Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process 1/9/2026

    Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.