Cell and Gene Logistics

  1. Navigating Conflicting Raw Material Preferences With Your CDMO 12/4/2025

    Choosing raw materials is both a scientific and a business decision. In a perfect world, you as the sponsor and your CDMO would agree on raw material fitness based on the data. But cost and availability are important factors, too.

  2. Managing Risk With A Platform 12/4/2025

    Once your quality team has defined your priority risks, a platform designation can help whip them into submission. Building a platform alongside novel drug development gives you a template rooted in prior knowledge to control risks for subsequent products.

  3. Reclaiming Control From Your Raw Materials 12/4/2025

    The high cost of GMP-grade materials and testing threaten to cripple biotechs and academic labs. Understanding your purpose is the first part of reclaiming control of your product and process. If you want to publish papers, research-grade material should be sufficient from start to finish.

  4. Deciding When Research Grade Raw Materials Are Sufficient 12/4/2025

    Qualifying raw materials is an investment, but mimicking the manufacturing process at small scales lowers the risk of throwing out material because it doesn't work at large ones, Lawrence Thompson said during this segment of Cell & Gene Live "Viability On The Line."

  5. Balancing Innovation With Manufacturability When GMP-Grade Is Unavailable 12/4/2025

    Some raw materials simply aren't available in GMP. Experts Yan Zhi and Lawrence Thompson describe risk assessment approaches that inform sourcing decisions in this segment from Cell & Gene Live "Viability On The Line." Some investigational therapies require many unique raw materials, and controlling them appropriately gets tricky. Complexities also vary by modality and batch size. Control strategies must be adaptable.

  6. Building Supply Chain Resilience When Dual-Sourcing Isn't An Option 12/4/2025

    Crafting a resilient supply chain, one where redundancy is out of the question, is easier said than done. Robust communication with suppliers helps ensure mutual understanding of needs. Preventing waste is a no-brainer but challenging to execute. Thoroughly characterizing critical quality attributes may offer some flexibility in choosing raw materials, in some cases, when they become scarce.

  7. Resilience By Design: Lessons From Real-World Disruption 12/2/2025

    Resilience is the bridge to patient access. Discover how to design your logistics with intentional flexibility to withstand real-world disruptions and protect product integrity under pressure.

  8. Why Supply Chain Integration Matters In Advanced Therapy Manufacturing 12/2/2025

    Fragmented supply chains increase risk and delay execution. Integration is key to establish a unified framework that enhances control, reduces administrative burden, and ensures program predictability.

  9. Why Shipping System Qualification Matters In Advanced Therapies 12/2/2025

    Ensuring the integrity of advanced therapies requires documented evidence of robust shipping processes. Qualification is essential for compliance and maintaining continuity across the supply chain.

  10. Built Or Bought? Why Biotechs Are Outsourcing Supply Chain Infrastructure 12/2/2025

    Scaling advanced therapies requires navigating extreme logistics and regulatory hurdles. Learn why moving to a flexible, outsourced model is essential for freeing capital and mitigating global risk.