BBG Advanced Therapies provides integrated cGMP biomanufacturing services that support the transition from research to regulated production. Our facilities, systems, and teams are designed for precision, control, and reliable scalability, helping programs move from early development to commercial readiness with confidence.
The BBG Advanced Therapies biomanufacturing environment is engineered to meet the exact standards of advanced therapies, with controlled, modular spaces and validated systems that support consistent, compliant operations the facility is designed to be compliant with FDA, EMA, and PMDA production requirements.
Key features include:
with independent Air Handling Units, HEPA filtration, and pressure control
including bioreactors and Tangential Flow Filtration systems
for phase-appropriate handling and storage
programs covering particulate, microbial, and physical parameters
supporting equipment and process readiness
for real-time traceability
enabling smooth handoffs across the production lifecycle
capabilities, supported by BioBridge Global’s enterprise infrastructure
This environment provides the stability, control, and reproducibility needed to manufacturing.
Inside this controlled environment, BBG Advanced Therapies delivers a full suite of biomanufacturing services to support the development and scale-up of advanced therapies. Our team partners with you from early process design through cGMP commercial production.
Our 2,600-square-foot Process Development Lab offers in-house analytical testing, custom assay development, cell isolation and selection, and optimization through scale-up to an 80L bioreactor.
Our 6,700-square-footbiomanufacturing space supports a wide range of production volumes, including a series of 250L bioreactors. Designed to comply with global 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) capability to provide phase-appropriate support consistent with current Good Manufacturing Practices (cGMP). Regulatory and compliance professionals maintain alignment with cGMP standards and coordinate engagement with governmental agencies. These capabilities include regulatory submission support and CMC documentation to help advance programs from early development through clinical evaluation and toward commercialization.
Our organization complies with numerous U.S. and international standards, including ISO 9001:2015.
