Children’s Hospital of Philadelphia (CHOP)

We provided expert cGMP and process engineering consulting services for this award-winning Clinical Vector Core (CVC) project. We were highly influential in the layout and HVAC design for the CVC which was designed to accommodate the process development, scale-up, manufacture, and certification of AAV and LV-based clinical grade viral vectors in support of Phase I/II clinical trials. Our team organized and executed the cGMP risk assessment, wrote the Type C package that CHOP submitted to CBER at FDA, and participated in the CBER presentation. This project had unusual design challenges that were headlined by the subterranean location in the building and the previously-installed vivarium that surrounds the 9000 ft2 CVC facility. CBER green-lighted the project immediately after the Type C presentation.