A venomous project

The biopharmaceutical company, Protherics, was formed in September 1999 through the merger of Proteus International and Therapeutic Antibodies. The company's products are based upon two proprietary technology platforms: highly purified polyclonal antibodies for acute medical emergency applications and novel peptide-conjugate vaccines to treat chronic diseases. In January 2001, the company launched its first FDA-approved product Cro-Fab. Cro-Fab is the first new rattlesnake anti-venom on the US market in 50 years. In August 2001, the company received FDA marketing approval for DigiFab, a treatment for the toxic effects of overdosage with the heart drug Digoxin. Protherics has a pipeline of products in research and development, including a vaccine for the treatment of high blood pressure, one of the largest worldwide pharmaceutical markets. Clean Room Construction designed, built and commissioned a 240m2 pilot plant cleanroom suite for Protherics UK, which was successfully completed in February this year. Work has now started on the Manufacturing Expansion Facility, which is scheduled for completion next February. The expansion is being housed partly in an existing 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 ISO 14644-1 class 7 & 5 areas arranged off a central access corridor spine. Three independent HVAC zones are provided, segregating upstream and downstream processing and finished goods storage. Both 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.

Going forward In June, 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. One hundred and eleven people are employed in the Blaenwaun facility where Protherics manufactures CroFab and DigiFab. As Andrew Heath, the chief executive, explained: "Demand for CroFab continues to increase as its use expands into the earlier treatment of milder bites and also into Copperhead bites, a previously un-served market." President Bush is known to have a supply of CroFab ready at hand on his ranch in Texas. Protherics has doubled its production capacity over the past 12 months. As a result, batch yields are increasing and significant progress has been made in reducing the cost of goods. With a strong order book, the company continues to invest in production capability.