Fermentation and purification capability form a core competence at Unitech Pharma.  The facility, consisting of a Fermentation and Purification plant, is equipped with state-of-the –art upstream and downstream capabilities. The facility can currently handle Class I and II organisms, focusing on bacterial and yeast expression.  

The core of the facility is a fermenter with a working capacity of 5, 250 or 500 L, and a 7 L inoculation fermenter. For cell harvest there is currently a 16 m² filtration system. An additional 10 m2 filtration system is available for product concentration. The fermentation process is guided by a Genesis control system.

To purify the product there is equipment for centrifugation/precipitation, ultra filtration and chromatographic technology.

Room is also available for complementing the purification stage with equipment specific for each product. There are Class C room with LAF (Laminar Air Flow) hoods, for filling of finished API. Ventilation and air management, Water for Injection (WFI), and steam, all comply with current cGMP demands.

Quality Assurance/Quality Control (QA/QC) operations are on-site, capable of performing standard analyses and microbiological checks.

The Facility has all the necessary permits (Medical Products Agency, County Administrative Board, Work Environment Agency), fulfils current cGMP requirements and is approved by the pharmaceutical agencies of the EU and Canada, WHO and approximately 35 additional countries

Mammalian cell systems cannot be produced in the Unitech Pharma facility but can be handled through the network.