cGMP Manufacturing
Our philosophy is ‘compliance by design’. This is equally appliable to production processes and production facilites. The result is a high quality robust build, with three segregated clean room suites which in combination provide the capacity to manufacture mammalian, microbial and viral technologies (to Category level 2 containment) for the production of natural or recombinant proteins, whole cells or virus products.
Quality...
Full flexibility of the suites is achieved through a combination of design features which include skid-mounted equipment, break out panelling, fallow space, additional utility points and a high reliance on disposable technology. Validated equipment from highly reputable suppliers, robust utilities with pre-specified redundancy together with a team of dedicated pharmaceutical engineers ensures that the facility operates consistently and remains within control.
...and flexibility
The adaptable nature of the suites without the constraints of a platform technology ensures that there are very few biotech-based products that we cannot manufacture. The range of cGMP production services and capacities initially available include the following:
Cell banking:
- Eukaryotic and prokaryotic cell bank production and storage
- Viral seed stock production and storage
Fermentation batch/fed-batch and perfusion:
- Mammalian - up to 200L with capacity for a second 200L vessel
- Microbial - up to 100L with capacity for a second 100L vessel
- Viral - various disposable systems up to 25L volume with facility to run 20L fermenter in the future
Downstream purification technologies include:
- Homogenisation
- Continuous and batch centrifugation
- UF/MF and diafiltration
- Depth filtration
- Chromatography (IEX, HIC and SEC Affinity)
