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Expertise in microbial fermentation is central to PBL’s business and the production of our life-saving products. This is especially key to our manufacture of Erwinase and the investment which the company has made in recent years
This includes a new state-of-the-art fermentation facility which has been designed and built around a 3000 litre fermenter, giving a significant increase over existing capacity and which will enable PBL to increase the amount of product we will be able to manufacture in the future.
The new multi-million pound building has a footprint of approximately 2100m2. This includes the main fermentation hall, down-stream processing rooms for harvesting product, plus all the associated services of purified water, steam, air and effluent treatment that are required in a modern pharmaceutical facility that meets the latest regulatory standards.
These systems have been designed to interact seamlessly and are operated by the latest process-control system. This will enable PBL’s production technicians to easily view and control any of the component parts via a series of hi-tech interactive screens.
We have also invested in other resources to meet increased manufacturing demands including the construction of a second new facility with an integrated filling line for Erwinase. This covers the entire process, from washing, depyrogenation and filling to stoppering, freeze drying and capping of vials containing the drug product.
Filling, lyophilisation and capping are contained under grade-A laminar flow HEPA filtered air, with all critical parameters for batch release of filled vials, such as temperature, time and filling accuracy collected and verified by a fully validated control & data acquisition system.
These new facilities, together with our commitments to develop and maintain our highly trained staff, will ensure that we are able to meet the latest regulatory standards and continue to manufacture Erwinase® to treat children and others with leukaemia.
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