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 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