Insights On Regulatory Compliance

  1. Gain Support For Your Regulatory Submission Process 3/27/2024

    Join us in this video as we delve into invaluable tips, cutting-edge tools, and unwavering support that Cytiva offers to facilitate your documentation progress.

  2. A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems Validation 6/9/2025

    Learn practical strategies for validating microbial identification systems in cGMP. Understand regulatory guidance and master a complete Computer Systems Validation plan for full compliance.

  3. Contamination Control Strategies For Gene Therapy Manufacturing 7/23/2025

    Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

  4. Build An AAV8 Platform: Lessons From A Collaborative Development Journey 11/5/2025

    Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

  5. Principles And Practice Using SEC For Reliable Peptides Analyses 8/26/2025

    Discover new SEC columns that enable reliable separation of biotherapeutic peptides to enhance CQA measurements for improved safety, efficacy, and quality across LC platforms.

  6. Characteristics Of Environmental Residues And Protocols For Removal 4/1/2025

    Examine disinfectant residue characteristics, impacts, and removal challenges in cleanrooms, as well as learn about the practical requirements for maintaining cleanliness standards and addressing these residues effectively.

  7. Accelerating Method Development And Manufacturing Of GLP-1 Analogs 7/29/2025

    Explore a streamlined LC-UV/MS workflow that empowers labs to meet rising GLP-1 drug demand with faster, more informed decisions that enhance compliance and impurity detection efficiency.

  8. Modular Facilities With Smaller Footprint Through Dynamic Perfusion 6/30/2025

    Discover how a top CDMO leveraged dynamic perfusion technology to boost biomanufacturing throughput, cut capital costs, and enable flexible, multi-modality production.

  9. Translating Study Reports – A GLP Draft Guidance 5/6/2024

    The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.

  10. Developing A Project Management Office (PMO) At A Small Manufacturing Site 8/11/2025

    Discover how implementing a Project Management Office transformed a small manufacturing site into a high-performing, strategic asset within a global network.