Cell and Gene Regulatory

  1. Regulatory And Biosafety Testing Expertise 3/31/2026

    Advancing biologics requires confidence in safety, quality, and compliance. Learn how integrated analytical and biosafety testing, backed by decades of expertise, helps reduce risk.

  2. The Slow Drift Toward Variability And The Case For Standardization 3/30/2026

    Small, early operational decisions accumulate over time, creating hidden variability that emerges at scale, making standardization essential for stability, reproducibility, and regulatory confidence.

  3. Building Stability Through Integrated Cryopreservation 3/30/2026

    Early integration of standardized, GMP-aligned cryopreservation improves consistency, documentation, and scalability in advanced therapy programs as they progress toward regulatory submissions.

  4. Stay Audit-Ready: Practical Compliance Insights For Research Sites 3/26/2026

    Gain an auditors insight into common compliance gaps and learn practical ways to strengthen audit readiness in sIRB studies.

  5. Regulatory Affairs 3/25/2026

    In today’s clinical environment, navigating regulatory complexities isn’t optional — it’s essential.

  6. Drug Safety 3/25/2026

    Drug safety is too important to entrust to underqualified teams or unpredictable models.

  7. Regulatory Operations 3/25/2026

    At inSeption Group, our Regulatory Operations team brings together specialized expertise, advanced technology, and seamless collaboration to get your submissions right—the first time.

  8. Galvanizing Large And Small For Clinical Success 3/25/2026

    See how two academic investigators accelerated corneal regeneration and lung fibrosis therapies from preclinical research to clinical trials by leveraging scalable GMP solutions and regulatory-ready materials.

  9. Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka 3/24/2026

    On episode 125 of Cell & Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group's Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach.

  10. How hMSCs Are Helping Power Organ-On-A-Chip Science 3/24/2026

    Explore how hMSCs power organ-on-chip systems through multipotency and scalability—from Georgia Tech's bone marrow models to ISS microgravity experiments and precision bioprinting innovations.