The Center for Breakthrough Medicines, a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia's Cellicon Valley, announced the opening of their analytical testing services laboratories that will deliver the most comprehensive testing capabilities in the industry. These vital service offerings address growing capacity needs in the severely supply-constrained cell & gene therapy market. 

More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline. This volume, combined with FDA's increased scrutiny, has caused bottlenecks for product release results, with testing queues of up to 8 months. By 2025, the FDA expects to receive upwards of 200 investigational new drug (IND) applications for cell and gene therapies annually, with an estimated approval of 10 to 20 cell and gene therapies each year. This unprecedented growth comes with challenges, particularly in testing. Tremendous backlogs in critical long-lead assays across the industry are leading to 6–12-week delays for cell-based methods, safety assays, and advanced analytics.

CBM's testing services will support custom assay development, characterization, and release for cell and gene therapy products, as well as for biologics, vaccines and plasmids. Regardless of a company's development stage, CBM offers tailored solutions from IND through commercialization and lot release.

"Our laboratories support R&D and GMP testing services, enabling the continued expansion of the on-site capabilities that can be scaled up at our expansive King of Prussia facility," said Dana Cipriano, Senior Vice President of Testing and Analytical Services, Center for Breakthrough Medicines. "Our testing service is backed by strong scientific expertise and advanced analytical equipment and is located across the hall from our Process Development and Manufacturing Operations, allowing us to offer a complete on-site end to end service for our manufacturing clients as well as the option for standalone external testing for our clients.