Cell and Gene Logistics

  1. Accelerating Milestones And Reducing Regulatory Risk 12/10/2025

    Modern adaptive Phase 1 oncology trials speed timelines, refine dosing, and meet FDA standards, replacing outdated 3+3 methods to boost efficiency, safety, and regulatory success.

  2. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

    Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

  3. Strained Manufacturing, Complexity Stymie In Vivo Progress 12/4/2025

     Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.

  4. Understanding The Real Risk When Using Research-Grade Material For In-Human Testing 12/4/2025

    When it comes to putting medicine made with research-grade raw materials into people, experts say: proceed with extreme caution. "There are a lot less controls than you think," says Lawrence Thompson in this segment of Cell & Gene Live "Viability On The Line." Beyond material quality, facility controls play a critical role. He doesn't choose materials unless he can visit the facility and put eyes on their processes, he said.

  5. Ensuring The Raw Material Data Package Supports Regulatory Filings 12/4/2025

    The license holder is responsible for data reliability — full stop. Sponsors have two levers to manage that with their CDMOs: the quality agreement and auditing, Lawrence Thompson says in this segment of Cell & Gene Live "Viability On The Line." Your contractor may be responsible for development, but you are responsible for the outcome.

  6. 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.

  7. 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.

  8. 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.

  9. 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."

  10. 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.