Singapore: Australian scientists have overcome one of the most pressing problems facing the pharmaceutical industry, how to create antibodies that are stable enough to meet stringent requirements necessary for production in large quantities, injection into patients and long-term storage.

Members of the Antibody Engineering Laboratory at Sydney's Garvan Institute of Medical Research, Dr Daniel Christ and PhD students Kip Dudgeon and Romain Rouet, have developed specific mutations that universally increase the stability of antibody molecules. The breakthrough finding has been published in the early online edition of the Proceedings of the Academy of Science (PNAS), the journal of the United States National Academy of Sciences.

"When we talk to collaborators in industry, we find that 30-50 percent of the antibody-based drugs they develop have to be put on hold because they don't meet quality tests that the companies or regulatory agencies such as the US Food and Drug Administration, require before marketing or approving these molecules," said Dr Christ.

"Until now, the issue of antibody instability has been tackled on a case-by-case basis, which is only tinkering with the problem. When you're dealing with such a diverse population of molecules, you have to make sure that the method you develop is generally applicable - and that's what we've done."

Produced by the immune system in response to infection, there can be as many as 100 million different kinds of antibodies in the circulation of a single human being.