Cell and Gene Regulatory

  1. Get Your Ducks In A Row For GMP Cell Manufacture 3/24/2026

    Uncover strategies to reduce cell bank development from years to months. See how GMP-compliant partnerships eliminate redundant documentation and accelerate your path to first-in-human trials.

  2. 10 Clinical Research Practices That Feel Like Compliance (But Aren't) 3/24/2026

    Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.

  3. Ensuring Quality Of CGT Materials 3/24/2026

    Here's why strong material selection, risk-based controls, and early analytics are critical for successful CGT development.

  4. Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials 3/24/2026

    Zymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.

  5. Transform Clinical Data Management Through A Unified Workspace 3/23/2026

    Discover how unified clinical data infrastructure replaces spreadsheets with AI-driven oversight, delivering traceable decisions and regulatory-ready documentation that accelerates timelines.

  6. AI-Powered Custom Listing Generator 3/23/2026

    Explore how natural language queries enable instant clinical listings while maintaining oversight, as well as what becomes possible when teams reduce manual effort without sacrificing control.

  7. A Risk-Based Decision Framework For Selecting Aseptic Barrier Technologies 3/20/2026

    EU GMP Annex 1 requires a risk-based approach to selecting Isolators or RABS. This framework evaluates human intervention and decontamination to ensure robust sterility assurance.

  8. UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk 3/20/2026

    Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

  9. Empowering Glove Integrity Testing: Successful End User Training On The Esco IntelliGlove Tester (EIGT) In Bangladesh 3/19/2026

    Advanced wireless testing ensures glove and barrier integrity in sterile manufacturing. These tools support ISO compliance and Annex 1 standards to strengthen contamination control.

  10. Ensuring Performance And Compliance: Successful FAT Of Filling Line Isolator For Creative Lifesciences, Taiwan 3/19/2026

    Rigorous Factory Acceptance Testing ensures filling line isolators meet performance and safety standards. This validation is vital for aseptic integrity and protecting both product and operator.