Monoclonal antibodies are the fastest-growing biopharmaceutical product category, accounting for an estimated 25 per cent of phase II clinical trials.

Antibodies are proteins which the body produces to defend itself against bacteria, viruses and other infectious agents. Each antibody is extremely specific, recognising and binding to a single molecular marker. It is this remarkable targeting ability which makes antibodies so promising, for example, as anti-cancer agents. When the antibody is paired with a cytotoxic agent, eg. a radioactive isotope, the resulting ‘smart drug’ locks onto the cancer cells and delivers radiation to destroy them, without harming the normal cells.

About 25 years ago, a technique for producing useful quantities of specific antibodies in the laboratory – so-called monoclonal antibodies – was discovered. While this major advance opened the door to the development of antibody-based therapeutic agents, significant challenges remained before the potential of monoclonal antibodies in human medicine could be realised. Now, owing to refinements in technique including the development of ‘humanised antibodies’, we are seeing a strong revival of interest in monoclonal antibodies. In the first half of 2003, four of the seven new biopharmaceutical drugs approved by the FDA were monoclonal antibodies.

There are currently almost 180 monoclonal antibodies in the biopharmaceutical development pipeline. These compounds target a wide range of diseases, from rheumatoid arthritis and asthma to various forms of cancer. Some of these new treatments have the potential to become blockbuster drugs – and this will require new technologies for producing pure antibodies in large volumes, quickly and reliably.

Our customers in the biopharmaceutical industry asked us to help them solve their problem. Working in collaboration with customers at our laboratories in Uppsala, Sweden, we were able to incorporate customers’ recommendations as we developed the process from the pilot stage to full industrial scale. And we came up with the answer. MabSelect is a novel protein A-based purification medium especially developed for the high-throughput capture of monoclonal antibodies from cell culture material. This new product can process 10,000 litres of cell culture a day, with both improved yields and process stability for our customers. Moreover, the agarose-based resin is free from contact with products from animal or human sources, eliminating regulatory concerns about impurities.

We offer a wide range of media and equipment for antibody capture and purification, whatever the scale and whatever the demands – because by helping our customers solve their manufacturing problems, we help deliver promising new treatments more quickly to patients.

The Protein Separations business area of Amersham Biosciences is the market leader in chromatography systems, membrane products and media for the purification of proteins, which are used in laboratory research and in the development and manufacture of biopharmaceuticals. Our products are used in the manufacture of over 90 per cent of all biopharmaceuticals on the market.