01.06.26 -- STREAM Edition: The Real Risk When Using Research-Grade Material For In-Human Testing

Explore how cross-functional teams streamline cell therapy manufacturing and release for Phase 1 trials to meet patient timelines and ensure safe delivery of personalized treatments.

The number of AAV-mediated therapies in clinical trials continues to rise, increasing demand for doses. A scalable platform is crucial to ensure a seamless transfer from pre-clinical to commercial.

With the demand for specialized equipment that can effectively meet evolving needs, learn about innovative solutions and gain insights into incorporating scalability from the early stages of equipment development.

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.

Learn about the obstacles patients encounter when seeking CGTs and explore how technology and patient services can empower manufacturers and clinical teams to help patients overcome barriers.

From enabling earlier insights through donor characterization to reducing manufacturing variability through cell separation technologies, explore real-world case studies and actionable approaches to scale smarter.