AB SCIEX, a global leader in life science analytical technologies, and the University of Melbourne today announced a joint technology development project to improve drug metabolism studies of biopharmaceuticals. This project is focused on developing a standardized testing methodology based on a breakthrough approach that scientists at the University of Melbourne pioneered on the AB SCIEX QTRAP^® 5500 System as the life science industry's first way to follow the fate of the breakdown of protein-based drugs in vivo. This approach could help drug discovery scientists better determine the effectiveness and safety of peptide and protein therapeutic agents that are advanced through regulatory processes and ultimately sold on the consumer market.

Biopharmaceutical development is the fastest-growing area within the pharmaceutical industry. Approximately one-third of all pipeline products in active development are biopharmaceuticals. Regulatory requirements for assessments of these protein-based drugs, or biologics, are expected to rapidly evolve, requiring a description of a drug's metabolism and how it may affect overall elimination of the drug from the body. The way it metabolizes can significantly affect the drug's efficacy and safety.

Drug discovery scientists currently do not have the ability to follow the fate of the breakdown of protein-based drugs in vivo without knowing what they are ahead of time. Providing this capability is critical for advancing drug metabolism studies of biopharmaceuticals. To address this need, scientists at the University of Melbourne invented a new approach using mass spectrometry to do these tests and are partnering with AB SCIEX with the goal of making the new solution available to any scientist conducting these types of studies.

Large biopharmaceutical companies as well as pharmaceutical companies with growing biopharma operations have already provided positive feedback about this mass spectrometry-based approach. To ensure that the new solution meets the evolving requirements for drug discovery and development, AB SCIEX will continue to engage with biopharmaceutical scientists around the world to obtain feedback, share scientific insight and refine the novel approach.

This development project is based on AB SCIEX mass spectrometry technology. The team of developers is customizing the approach for QTRAP technology as well as the AB SCIEX TripleTOF™ 5600 System, which is the industry's fastest and most sensitive high-resolution mass spectrometer for high-performance qualitative and quantitative analysis. As part of the project, the developers are developing a new workflow and creating specialized software to centrally manage it, giving drug discovery scientists more control.

Anthony Purcell, Ph.D., Associate Professor, Senior Research Fellow and a Principal Investigator at the Department of Biochemistry and Molecular Biology, The Bio21 Molecular Science and Biotechnology Institute at the University of Melbourne

"Targeting the unknown breakdown products of a biologic without knowing what they are is revolutionary in the biopharmaceutical industry. The technology we are developing with AB SCIEX will give scientists the unique ability to produce metabolism profiles for peptide and protein drugs that the industry simply cannot do right now. This is essential for advancing an increasing number of biopharma drugs to market."

Dave Hicks, Vice President and General Manager of the Pharmaceutical and Omics Business, AB SCIEX

"AB SCIEX is driving the exploration of unique new workflows that will continue to aid pharmaceutical scientists. We are building on our more than 20 years as a trusted partner in drug discovery and development. Teaming up with distinguished scientists in academia enables us to combine our best-in-class technologies with innovative ideas. Our long-standing relationship with the University of Melbourne gives us the opportunity to help advance biopharmaceutical development with a novel way to conduct metabolism studies."

Source : AB SCIEX