February 22, 2022 -- The Center for Breakthrough Medicines (CBM) announced the opening of its analytical testing services laboratories. CBM's services will support custom assay development, characterization, and release for cell and gene therapy products, as well as for biologics, vaccines, and plasmids.
By 2025, the U.S. Food and Drug Administration expects to receive upward of 200 investigational new drug applications for cell and gene therapies annually, with an estimated approval of 10-20 cell and gene therapies each year. This unprecedented growth comes with challenges, particularly in testing, said CBM in a press release. Tremendous backlogs in critical long-lead assays across the industry are leading to six- to 12-week delays for cell-based methods, safety assays, and advanced analytics.
CBM's testing and analytical services provide an integrated and comprehensive portfolio of services to its clients all on one campus located in Philadelphia's Cellicon Valley, with the goals to dramatically shorten development timelines, greatly reduce regulatory risks, and accelerate cures for patients.
CBM is a cell and gene therapy contract development and manufacturing organization.
Copyright © 2022 scienceboard.net