Regulatory Articles

  1. Flow Chemistry For Contemporary Isotope Labeling 1/26/2026

    Gain insight into how late‑stage exchange and flow‑based methods enable efficient access to labeled molecules for pharmaceuticals, mechanistic studies, and analytical applications.

  2. Product Carbon Footprints: The Next Frontier In Sustainable Innovation 12/12/2025

    Product Carbon Footprints reveal true lifecycle emissions, enabling collaboration, innovation, and informed decisions. Learn why moving from estimates to evidence is essential for reducing Scope 3 impact.

  3. Take Action On PFAS To Protect Your Critical Processes 9/18/2025

    PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.

  4. What Are PFAS And How Do They Impact The Biotech Industry? 9/13/2025

    Forever chemicals pose rising health risks and regulatory challenges. Learn how increasing restrictions on fluorinated compounds could reshape manufacturing, packaging, and sustainability strategies.

  5. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

  6. Overcoming Gene Therapy Cost Roadblocks On The Path To Patients 7/23/2025

    Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.

  7. Viral Gene Therapy: Reducing Costs To Improve Patient Access 7/23/2025

    Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.

  8. FDA Leading The Decline Of Animal Testing 7/16/2025

    The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).

  9. 3 Key Considerations In Gene Therapy Manufacturing 7/15/2025

    Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.

  10. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.