Cell and Gene Regulatory

  1. AI-Readiness In A Regulated World: A Practical Playbook For Life Sciences 9/2/2026

    Uncover how life science teams build defensible governance, maintain human oversight, and manage regulatory risks when adopting advanced digital tools.

  2. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

    Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

  3. The New Rules Of Developing Novel AAV Capsids 9/2/2026

    The shift toward engineered AAV capsids is expanding therapeutic possibilities while making manufacturability, analytical readiness, immunogenicity, and regulatory strategy integral to vector selection from the earliest stages of development.

  4. Semi-Automatic Assembly System: Assembly Lab 9/1/2026

    Bridge laboratory development and small-series production with flexible device assembly, process monitoring, and production-level controls designed to support changing applications on one platform.

  5. Diagnostic Products: Technologies For Precision Diagnostics 9/1/2026

    Streamline diagnostic manufacturing from initial laboratory testing through high-volume commercial production. Modular assembly platforms offer precise liquid dosing to ensure regulatory compliance.

  6. Faster Paths To Biosimilar Equivalence: Turning Guidance Into An Advantage 9/1/2026

    Evolving biosimilar guidance creates opportunities to reduce comparative clinical requirements through strong analytical evidence, risk-based justification, structure-function knowledge, and more.

  7. The New Reality Of Particulate Risk: What Drug Manufacturers Need To Know 8/31/2026

    Particulate-related recalls account for 37% of US FDA injectable drug actions, and evolving FDA and EU GMP requirements are raising the compliance bar for manufacturers.

  8. Preclinical Genome Editing Risk Assessment Services 8/31/2026

    Regulatory-aligned off-target risk assessment for genome editing programs, from early guide RNA screening through IND-enabling confirmation studies, structured to support FDA submission requirements.

  9. Robust Database Characterizes And Optimizes Product Development 8/29/2026

    Integrating material characterization data with process parameters accelerates drug development, reduces empirical testing, and strengthens regulatory compliance.

  10. Strategic ADC Development In A Shifting Regulatory Landscape 8/28/2026

    As ADC development grows more complex, sponsors must align safety, dose optimization, global trial design, regulatory strategy and CMC readiness early to reduce risk and accelerate approval.