AB Sciex and the University of Melbourne entered a joint technology-development project to improve drug metabolism studies for biopharmaceuticals. The project is focused on developing a standardized testing methodology based on an approach scientists at the University of Melbourne pioneered on the AB Sciex Qtrap® 5500 System to follow the fate of the breakdown of protein-based drugs in vivo.
Biopharmaceutical firms as well as pharma companies with growing biopharma operations have provided positive feedback about this approach, according to AB Sciex and the University of Melbourne. To ensure that the new solution meets the evolving requirements for drug discovery and development, AB Sciex will continue to engage biopharmaceutical scientists to obtain feedback, share scientific insight, and refine the approach.
AB Sciex and the university team are customizing the approach for Qtrap technology as well as the AB Sciex TripleTOF™ 5600 System. They are also developing a new workflow and creating specialized software to centrally manage it.
Regulatory requirements for assessments of protein-based drugs are expected to evolve, requiring a description of a drug’s metabolism and how it may affect overall elimination of the drug from the body, according to the collaborators. 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. To address this need, scientists at the University of Melbourne invented a new mass spectrometry-based technique to conduct such tests.
“Targeting the unknown breakdown products of a biologic without knowing what they are is revolutionary in the biopharmaceutical industry,” notes 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. “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.”