Charter Medical Cell & Gene Tech Expo April 2026: Commercial Readiness

Cryopreservation is a sophisticated system that bridges the gap between manufacturing and clinical administration. Rather than a standalone freezing step, it is a continuous chain where decisions made during formulation, filling, and storage interact to shape the final therapy's potency and identity. Success depends on balancing the delicate intersection of cellular biology, heat transfer dynamics, and material science. Because polymers and containment systems behave uniquely at cryogenic temperatures, early design choices regarding geometry and material integrity are vital to preventing latent failures that may only surface during late-stage scale-up or validation.

Anticipating these interactions through early engagement with a technical partner helps mitigate risks before regulatory constraints lock in process parameters. As programs transition from clinical to commercial scales, standard portfolio solutions may require thoughtful customization to align with specific automation needs and site-to-site variability. By treating cryopreservation as an integrated lifecycle, developers can ensure a robust chain of custody and consistent product performance.

Felipe Rivas, PhD, R&D Engineer II, Charter Medical, will discuss how advanced therapy manufacturers can customize single-use solutions and leverage freezing studies to design scalable, repeatable cryopreservation steps to reduce the risk of downstream delays and product loss.

About Charter Medical

Charter Medical, LLC has more than 35 years of experience developing and providing specialty single-use products for bioprocessing, advanced therapies, and blood management applications, delivering solutions to the biotechnology and pharmaceutical markets.

Our 16,000 square feet of cleanroom space located in Winston-Salem, NC, is ISO 13485:2016-certified and FDA-registered, with a focus on designing and supplying single-use solutions for cell growth, frozen storage, and biological fluid handling. Custom product design services are available for clients who need specialized single-use products for biomanufacturing.