Insights On Regulatory Compliance

  1. 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.

  2. Biomanufacturing Operator Training And Solutions 5/20/2025

    Discover a hands-on biomanufacturing training program that empowers operators with essential skills, boosts efficiency, and supports innovation in the fast-paced biopharma industry.

  3. Adapting To Evolving Regulations: Validation In A Changing Landscape 3/26/2025

    Discover how evolving regulatory expectations in life sciences present new challenges and opportunities, as well as gain insight into strategies from experts in the field to navigate risk-based validation processes.

  4. Development Of Separation Methods For GLP-1 Synthetic Peptides 6/30/2025

    Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

  5. How Bend Bioscience Standardized Operations And Boosted Compliance 8/8/2025

    Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

  6. Exploring The Potential Of Agentic AI 8/12/2025

    Discover how agentic AI is poised to transform Enterprise Asset Management in regulated industries to enhance compliance, reduce downtime, and bridge fragmented systems for resilient operations.

  7. Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing 8/20/2024

    Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

  8. The Impact Of The FDA's New CSA Draft Guideline 2/24/2025

    Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

  9. Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation 11/6/2024

    Industry leaders gathered at the PDA Ireland Chapter event to discuss how innovation and technology are transforming biopharmaceutical manufacturing, addressing challenges, and driving efficiency.

  10. Time To Intensify: Taking mAb Manufacturing To The Next Level 8/19/2025

    Explore how process intensification can revolutionize monoclonal antibody manufacturing to boost productivity, cut costs, and enhance sustainability with scalable strategies and real-world results.