GenCure is a full-service biomanufacturing organization that collaborates with clients to deliver comprehensive, cell and cell-based manufacturing solutions. Leveraging its showcase facility designed to be compliant with FDA, EMEA, and PMDA production requirements, GenCure focuses on translating and refining early-stage processes to scale for commercial readiness.
GenCure’s 2,600 SF Process Development Lab offers a comprehensive range of in-house analytical testing services, custom assay development, cell isolation and selection through optimization and scale-up to 80L bioreactor.
GenCure’s cGMP 6,700 SF cleanroom production space is sized for a wide range of production volumes up to a series of 250L bioreactors. Cleanrooms are designed to be compliant with U.S., European and Japanese regulations.
GenCure leverages the BioBridge Global enterprise quality management system and electronic batch records (EBR) to provide our clients phase-appropriate support. Our experienced team of regulatory and compliance experts interact with governmental agencies, support submission processes, and provide CMC-relevant content to ensure a smooth transition from pre-clinical and clinical evaluation to commercialization.
Our organization complies with numerous U.S. and international standards including International Organization of Standardization (ISO) 9001:2015. View our certifications here
