Biologics are the future

Biological medicines derived from genetic engineering technology are big business. They have proved very effective treatments for serious diseases.


Examples are the antibodies Herceptin and Humira, immunotherapies used to treat breast cancer and rheumatoid arthritis respectively. However, as these drugs are complex molecules used by genetically engineered living cells in culture, manufacturing process development can be time consuming and costly. This can mean that they are very expensive to use in the clinic and health services may have to make difficult cost/benefit decisions as to whether to make them available to patients.

Numerous new biological medicines are now in development - biopharmaceutical companies are actively developing next-generation engineered therapeutic biomolecules, as well as new gene and cell therapies. Increasingly, they are concerned with manufacturability - is it possible to actually make the complex biological drug product at the scale necessary to fulfil demand? Some potentially important therapies may be just too complex and difficult to make in a timely manner.

This is where new biomanufacturing technology can make a huge impact for biopharmaceutical companies and patients. Research led by Professor David James and his team at Sheffield concentrates on the design and development of next-generation biological medicines, by speeding their delivery to the clininc and reducing their manufacturing cost.

His laboratory works in partnership with several biotechnology and biopharmaceutical companies, ranging from small SMEs such as Absolute Antibodies (Redcar, UK) to large multinational companies such as MedImmune (the global biologics research arm of AstraZeneca). This work is inherently multidisciplinary, using engineering design priciples to improve the fuction of complex biological systems such as mammalian cells used as “drug factories” in manufacturing processes.

This is the impact of engineering. Biological discovery always comes first, as with the first antibiotic penicillin, but what enabled everyone to access the biological medicine is the design and development of robust, cost-effective manufacturing processes.

Professor David James

Chemical and Biological Engineering

“ The next generation of biological therapies set to revolutionise treatment of the most serious diseases that challenge human health will require similar innovation in manufacturing technology. In the future biomedicine development should not be limited by manufacturing technology, but by the ability of bioengineers to design new, potent therapies.” - Professor David James

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