Monoclonal antibodies are revolutionising the treatment of many illnesses and have become one of the main indicators of the direction drug treatments are shaping towards. Latest estimates of the European monoclonal antibody therapeutics market place a figure of between 11.4 billion (€8.7 billion) by 2011. The growth is fuelled by the need for safe and effective treatment alternatives to autoimmune and inflammatory disorders.
MAbs' excellent safety profile is due to its exceptional purity and specificity. Additionally, MAbs are able to recognise and bind to a specific antigen. They are used in many diagnostic procedures and form the basis of many new therapeutic products.
Three notable novel monoclonal antibody drugs include Genentech's Avastin (for cancer), ImClone/BMS/Merck KGaA's Erbitux (for cancer) received FDA approval and Biogen Idec/Elan's Antegren (for multiple sclerosis). Antegren received FDA priority review in July 2004 and is expected to launch in early 2005.
One of the tools, MabSelect Xtra (eXtra capacity) is a new recombinant protein A-based chromatography medium that captures antibodies with improved efficiency and economy. It is engineered to give 30 per cent higher dynamic binding capacity than other commercially available protein A-based media. This higher capacity translates directly into lower cost of production, especially when capturing antibodies from high-expression feedstocks.
The other tool, MabSelect SuRe (Superior Resistance) is a chromatography medium based on a novel alkali-stabilised protein A-derived ligand engineered to provide greater stability than conventional protein A-based media in the alkaline conditions used in cleaning-in-place (CIP) protocols. The use of sodium hydroxide with MabSelect SuRe means lower costs for cleaning and fewer failed batches. The medium is ideal for regular production or in early clinical phases/process development.
GE Healthcare's latest products aim to fill the demand from manufacturers, who are looking to handle larger volumes of higher titre feedstock, while extending media lifetime to help reduce the overall cost of production. All current predictions point to a much-increased demand for therapeutic monoclonal antibodies to treat disorders
"The success of monoclonal antibodies as therapeutics for the treatment of cancer and immunological diseases has driven the need for more time efficient and cost effective tools for the development and manufacturing of these antibodies on an industrial scale," said Peter Ehrenheim, president of protein separations at GE Healthcare.
Today, the industry is working hard to perfect the design and production of MAbs for therapeutic, diagnostic, and other purposes. Oncology, autoimmune and inflammatory disorders (AIID) have been identified as the primary areas of commercial prosperity. Oncology is likely to remain the leading revenue generator with sales of approximately $6.5 billion (€4.9 billion) forecast in 2011.
The AIID market is expected to follow a similar pattern with estimated sales of $4.5 billion in 2011. However, areas set to show less encouraging growth include the organ transplantation and infectious diseases sectors.
According to Frost and Sullivan, the next few years will see strategic alliances formed between mAb developers and big pharmaceutical companies, which will contribute to market growth. To capitalise on this both industries will need to continue to evolve towards offering competitive pricing, developing holistic solutions, from diagnosis to treatment to after care and providing technical and efficient customer care.