Our multi-product manufacturing facility is designed to meet both US FDA and EU EMEA GMP requirements. It houses a comprehensive production train for the production of mammalian cell-derived biologics. The production train consists of ISO 7 and 8 cleanroom processing suites that are linked via air-locks to a dual corridor system, which ensures unidirectional flow of personnel, equipment and materials. Biosafety cabinets and LAF located in the cleanrooms provide ISO 5 and EU Grades A/B areas.
Our GMP production capabilities include:
- GMP cell banking
- Preparation of sterile media and buffer
- Cultivation of mammalian cells in shaker flask and batch/fed-batch bioreactors (up to
500L scale)
- Harvest and concentration of products using UF/MF systems
- Downstream purification of products with viral inactivation and removal steps
- Final bulk formulation
Key Equipment in 2,000 m2 of GMP cleanroom area:
- Media and buffer preparation systems
- 40L, 200L, and 500L bioreactors
- Process Chromatography skids
- Ultrafiltration and microfiltration systems
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