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cGMP Manufacturing
We offer cGMP manufacturing services for both microbial and mammalian cell-based processes. We specialize in the production of therapeutic biologics such as recombinant proteins and monoclonal antibodies for pre-clinical and clinical supply.
Our facility is designed and constructed to be used for cGMP compliant contract manufacturing with a high degree of flexibility. It has been designed for optimal personnel flow, product flow and regulatory compliance. Each manufacturing suite is appropriately pressurized with respect to its surroundings to mitigate the risk of cross-contamination. Regulatory and product segregation features include multiple air-handling systems, unidirectional personnel and material flow.
We offer two separate lines for manufacturing, one for mammalian cell culture and the other for microbial fermentation. The facility design allows for the capacity and technological flexibility. All operations and procedures are carried out in accordance with cGMP regulations (US FDA 21 CFR, EU and WHO guidelines of Good Manufacturing Practice) and customer requirements.
The manufacturing facility comprises of:
- Independent state-of-the-art cGMP production suites for microbial fermentation and mammalian cell culture including Downstream purification
- Separate media prep, Glasswash, Preparation and Sterilization areas
- Appropriately segregated HEPA air handling systems
- Purified water, water for injection, clean steam generation systems
Our production area contains the following processing equipment:
Microbial Production Suite:
- Shake Flasks
- Shaker Incubator
- 2/5, 30 and 225 L WV Fermenters
- Homogenizer
- Microfluidizer
- Continuous and Batch Centrifuge
- Depth Filtration
- Tangential Flow Filtration (UF/DF) Skids
- Chromatography Systems
Mammalian Cell Culture Production Suite
- Shake flasks / Spinner flasks
- CO2 incubators
- Wave bioreactor (1 - 25 L WV)
- 2/5, 50 and 300L WV bioreactors suitable for Perfusion process
- Continuous centrifuge
- Depth filtration
- Tangential flow filtration (UF/DF) skids
- Viral inactivation and Filtration
- Chromatography systems
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