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Process development
Successful products require well defined, robust, scalable and reproducible processes that are commercially viable and regulatory compliant.
Our process development team has extensive expertise in all aspects of upstream and downstream development. The scientists who develop your processes are responsible for effective technical transfer to your manufacturing team and ultimately for successful scale-up.
Eden Biodesign’s facility has three segregated development suites. These mirror the cGMP suites for the dedicated application of viral, mammalian and microbial technologies and use the same, scaled down technology platforms. Each suite is fully configurable to meet client needs, including:
- Development cell banking:
- Production and storage
- Mammalian and microbial
- Viral seed
- Scales of operation:
- Upstream multiple bioreactors in:
- Mammalian from 1L to 20L
- Microbial from 1L to 30L
- Viral from 1L to 20L
- Disposable, scaleable fermentation technologies:
- Roller bottles
- Cell factories
- Single use bioreactors
- Potential to accommodate any developing technology
- Downstream processing capabilities:
- Mammalian, microbial, viral and scale–up purification development laboratories including:
- Primary separations
- Centrifugation
- Purification by microfiltration, ultrafiltration and diafiltration scale–up and scale–down
- Sartorius sartoflow alpha crossflow filtration unit
- Chromatography utilising Akta Explorer Systems and Akta Pilot Systems
