Regulatory Articles. App Notes, Case Studies. & White Papers

  1. 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.

  2. Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines 8/6/2025

    As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

  3. Risk Assessment Services Align With FDA Guidance For Gene-Edited Human Gene Therapy Products 7/29/2025

    Navigate the FDA's gene therapy guidelines with advanced risk assessment strategies. Optimize gene editing and ensure regulatory alignment for safer, more effective therapies.

  4. 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.

  5. 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.

  6. 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.

  7. 21st Century Manufacturing Of Injectable Pharmaceuticals 5/12/2025

    Discover how rising competition, niche patient populations, and evolving therapies are reshaping sterile injectable drug development with cutting-edge technologies.

  8. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

    Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

  9. Does Your Drug Require A Driving Study? Find Out What The FDA Says. 5/9/2025

    Some CNS drugs need to be assessed for their impact on driving ability. Driving simulation studies offer faster startup, lower cost, and no safety risk. Learn more and discover a real-life case study.

  10. Navigating The Complexities Of CNS-Active Drugs 5/9/2025

    In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.