BBG Advanced Therapies houses a full-service biomanufacturing facility and collaborates with clients to deliver comprehensive, cell and cell-based manufacturing solutions. Leveraging its showcase facility designed to be compliant with FDA, EMA, and PMDA production requirements, BBG Advanced Therapies focuses on translating and refining early-stage processes to scale for commercial readiness.
Our 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.
Our cGMP 6,700 SF cleanroom production space is sized for a wide range of production volumes up to a series of 250L bioreactors. Designed for compliance to global standards and regulations for Advanced Therapy Medicinal Products (ATMPs) and Human cell and tissue products (HCT/Ps).
BBG Advanced Therapies leverages the BioBridge Global enterprise quality management system and electronic batch records (eBR) to provide our clients phase-appropriate support that aligns with current Good Manufacturing Practices (cGMP). Our experienced team of regulatory and compliance experts ensure adherence to cGMP standards, 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.
