We offer a comprehensive solution for all your CGMP manufacturing needs from a fully integrated state-of-the-art facility, with end-to-end capabilities backed by over a decade of fermentation and cell culture experience.
Designed to meet the most stringent global regulatory demands, our facility has the capability to efficiently produce your simple and complex recombinant biotherapeutics from microbial and mammalian cell culture systems.
Leveraging systems with single-use components and flow paths ensures better regulatory compliance and greater operational flexibility, allowing us to drive down the cost of your biologics.
We offer manufacturing at the following scales:
- Microbial: A dedicated 1,000L fermenter capacity with supporting inoculum train and downstream operational trains
- Microbial fermentation: 100L, 1,000L (stainless steel)
- Downstream processing: Refold Tank, Disc stack centrifuge, UF/DF, Homogenizer, AKTA Pilot/Process Skids
- Mammalian – commercial suites:
- Phase-1 includes two suites of 2x200l single use bioreactors.
- Phase-2 consists of one suite of higher scale
- Drug product (DP) suites capable of handling pre-filled syringes, vials, devices and cartridges, including lyophilized formats