Just northwest of Philadelphia in King of Prussia, PA, academic scientists, startups, and big pharma can explore an array of analytical bioprocessing assays at The Discovery Labs. Dana Cipriano, vice president of testing and analytical services, describes The Discovery Labs as an ecosystem streamlining the path to commercialization for cell and gene therapies.
The Discovery Labs consists of three parts: The Center for Breakthrough Medicines, a contract development and manufacturing organization (CDMO); Unite IQ, an incubator and accelerator; and The Colony, an investment arm that provides funding for scientific innovators from academia and industry. As Cipriano explains it: “We offer an end-to-end solution for drug discovery and development through commercialization.”
In addition to the manufacturing, experts at The Discovery Labs focus on supporting analytical development and testing. Part of that includes a platform of assays—such as characterization, release, and safety assays—that can be used from preclinical through commercialization for cell and gene therapy products. To support the diverse mix of programs with the assay platforms, says Cipriano, “we have a mix of platform equipment that can be integrated into assay development or technical transfers that will allow flexibility to support our clients’ programs. Having these platforms also allows for expanded skillsets and experience of the scientists to execute the assays.”
Plus, Cipriano believes in thinking about analytics as early in a bioprocessing project as possible—“almost at the start.” She adds, “The in vitro methods must translate to the in vivo methods as you move along the lifecycle of a cell or gene therapy.” All along, though, the methods must be capable of adjusting as needed. “We build packages with planning activities, so you have the right amount of sample from a clinical run, for example, to do the comparability studies when changes need to be made to a method in later phases of development,” Cipriano says.
To support work as a CDMO, Cipriano and her colleagues plan to add more automation. “For the large body of analytical testing required, you need accuracy and efficiency.” In addition, Cipriano and her colleagues build partnerships with academic centers to develop assays for characterizing cell and gene therapies. Explaining the overall mission of The Discovery Labs, she says that they enable the development of cell and gene therapy products “from idea to patient.”