A venomous project revisited

Protherics is the first UK biotechnology company to have fully developed and manufactured two biopharmaceutical products to the approval of the US Food and Drug Administration (FDA). Sales from these products – CroFab, for the treatment of rattlesnake bites and DigiFab, for the treatment of digoxin overdose – have enabled Protherics to become one of only a handful of profitable European biotechnology companies. Clean Room Construction designed, built and commissioned a 240m2 pilot plant cleanroom suite for Protherics UK, which was successfully completed in February 2003. In June 2003, Protherics was awarded a Regional Selective Assistance grant from the Welsh Assembly Government to assist in the development of the company's FDA approved manufacturing facility in Blaenwaun, Ceredigion. The grant of up to £800,000 will be used to help with the planned development, to provide greater capacity, more flexibility and enhanced compliance to meet future regulatory requirements. The expansion area included the fallow area adjacent to Protherics' existing manufacturing plant, with the remainder housed in a new extension to the host building. The new facility will contain 440m2 of ISO14644-1 Class 7 and 5 areas arranged off a central access corridor spine. Three independent HVAC zones are provided, segregating upstream and downstream processing and finished goods storage. Clean Room Construction started work on the Manufacturing Expansion Facility in June 2003 and it was completed on time and on budget in March 2004. The work has been carried out while maintaining production, with the expansion area being linked into the existing facility during shutdown for regular maintenance. Both the pilot area and the manufacturing facilities have been constructed using CRC's own modular wall and ceiling systems with welded vinyl flooring throughout. There are large areas of modular laminar flow in most areas, which provide Protherics with a highly versatile cleanroom operation. One hundred and eleven people are employed in the Blaenwaun facility where Protherics manufactures CroFab and DigiFab.

Opening day Rhodri Morgan, the First Minister for Wales, led the opening ceremony, which was held on March 19 and attended by CRC's managing director Malcolm Davis. The First Minister said he was proud of the company's success in West Wales adding that it is a great example of a Wales–based company producing a world–class product and that he was proud of the part played by the Welsh Assembly in the company's successful expansion. He said that he never tired of telling people throughout the world that "We have a company here in Wales exporting rattlesnake anti-venom to the US".

Proven track record, future promise Protherics is unique in UK biotechnology in having proven capabilities in developing and manufacturing immunotherapeutic products to the strict regulatory standards of the FDA. Today, Protherics employs 190 staff across its operations in the UK, the US and Australia, and the company is looking to build on its proven track record. As the CEO, Andrew Heath, says: "Protherics is reaching a landmark point in the company's development as it reaches profitability and demonstrates that UK biotech companies can compete on the global stage. "The future has never looked so bright for Protherics as it starts to reinvest its profits in an exciting development pipeline."