Leland Foster, the president and chief executive of Fisher Biochemicals, told DrugResearcher.com that the increase in capacity had been driven by the growth of the biopharmaceutical industry and the large number of protein-based medicines coming out of companies' pipelines.
At present, 8 per cent of treatments given to patients are protein-based drugs, said Foster. In three to five years, this will increase to 20 to 25 per cent, he suggested, and companies that develop and manufacture these proteins will need the sort of materials that Hyclone can supply.
The new facility, based in Cramlington near Newcastle-upon-Tyne, expands on the existing infrastructure on the site and dramatically hikes the production of Hyclone cell cultures, media and buffers, as well as its bioprocess container bags.
Discussing the main features of the new plant, Foster said that it is thought to be the first purpose-built facility in the industry that provides a clear segregation of manufacturing for animal-derived and animal-derived-component free (ADCF) products.
One of the consequences of bovine spongiform encephalopathy (BSE) and the discovery that it can cross the species barrier has driven the market for animal-free materials, largely on concerns relating to the manufacture of preventive and therapeutic human medicines using animal derived components. But most suppliers manufacture in a common facility, so there is a potential from cross-contamination. Perbio's new facility eliminates this risk, said Foster.
The site includes: a Class C clean room for the manufacturing of bioprocess containers; two current Good Manufacturing Practice (cGMP) compliant, Class D sterile liquid manufacturing areas (one for ADCF and another for non-ADCF materials); a HyNetics module for automated hydration and mixing of powders and dispensing and packaging of liquids; and a dry powdered media (DPM) manufacturing area with micronisation technology.
Foster noted that the bioprocessing market is experiencing healthy growth at present, with the cell culture consumables market currently estimated at around $500 million and growing at a percentage rate of the low- to mid-teens per annum. Within this sector, however, animal components are showing sluggish growth (0-3 per cent), with much higher rates seen for animal/sera-free lines.
The greatest growth is expected for the bioprocess container market, however, a sector that Foster believes Hyclone leads because it is the only company at present that can offer media as well as the packaging in which they are carried.
This is of particular relevance as the majority of product orders require a bespoke element, e.g. in terms of the configuration of container, tubing and connectors. Competing companies tend to have to work with third-party container manufacturers, so Perbio can offer a more efficient, responsive service to customers, he said.
The bioprocessing container market is fairly small at present - at around $80-$100 million - but is growing at an estimated rate of 20-30 per cent a year and is becoming increasingly important to Hyclone.
Perbio is among the largest cell culture media suppliers, with other major players including Sigma-Aldrich, Cambrex, Invitrogen (via its Gibco subsidiary) and JRH Biosciences.