INSIGHTS ON CELL & GENE THERAPY LOGISTICS

• CGT Industrialization Starts With CDMO Alignment

  Fragmented processes are stalling progress. By aligning CDMOs through transparency and standards, developers can move past the COGS obsession and stabilize the supply chain.

• Manufacturing Made More Robust And Customer-Centric

  Discover how regional manufacturing, risk-aware practices, and agile strategies are reshaping supply chains to deliver resilience, transparency, and sustainability in today’s complex global environment.

• Metavate: Automated, Metadata-Driven, Data Transformation

  Embedded, flexible clinical services model that scales sponsor capacity, standardizes quality delivery, and accelerates clinical development while sponsors retain strategic and operational control.

• Accelerating Milestones And Reducing Regulatory Risk

  Modern adaptive Phase 1 oncology trials speed timelines, refine dosing, and meet FDA standards, replacing outdated 3+3 methods to boost efficiency, safety, and regulatory success.

• Why Your MVP And Its Evolution Matters To Manufacturing

  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.

• Strained Manufacturing, Complexity Stymie In Vivo Progress

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

• Understanding The Real Risk When Using Research-Grade Material For In-Human Testing

  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.

• Ensuring The Raw Material Data Package Supports Regulatory Filings

  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.

• Navigating Conflicting Raw Material Preferences With Your CDMO

  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.

• Managing Risk With A Platform

  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.