Cell Therapy GMP Manufacturing
State-of-the-art ISO 5 BSC and ISO 7 clean rooms to support GMP cell culture and manufacturing
GMP Manufacturing for Cell Therapy
State-of-the-Art Manufacturing Suites for Cell Therapy Manufacturing
At KBI Biopharma, we are at the forefront of the rapidly-evolving field of cell therapy, providing a wide range of cutting-edge services to support the development and commercialization of next-generation cell-based treatments.
KBI offers Ph I/II GMP manufacturing capabilities in ISO 5 BSC and ISO 7 clean rooms. Our GMP cell culture facility offers six independent culture suites, a unidirectional flow of personnel and materials, and environmental monitoring to support quality manufacturing processes.
KBI offers expertise in:
- Closed system & Single-use reagent formulations
- Parallel processing of cell therapy products
- Isolation and tracking via unique sample identifiers
- Fill and Finish per client’s instructions
- In house Bioburden, Sterility, Mycoplasma and Endotoxin testing
- GMP compliance monitored and maintained via KBI Quality Systems
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