Quotient Sciences Acquires Arcinova

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Our work and case studies

 

UPLC-MS/MS Analysis of Human Insulin and Insulin Analogues

Challenge: New formulations of human insulin analogues and new biosimilar products are needed to meet a burgeoning global demand for diabetes treatments. All of these treatments are tested in non-clinical trials first to ensure safety and efficacy for large scale clinical trials. Pivotal clinical studies require highly sensitive, precise measurement of multiple insulin analogues from a small volume of plasma. These trials can be with one or several different insulins and their metabolites.

Customer: European and Global Biotech Companies

Outcome: High sensitivity methods for human insulin and several fast and slow acting insulin analogues were developed and validated, meeting the client’s timeline for key clinical trials. In-house validated methods for six insulins/analogues reduces the timeline for bioanalytical support as no method development or validation time is required. Three high sensitivity Xevo-TQXS mass spectrometers have now been installed, each capable of supporting clinical trials for insulins around the clock.

 Insulin Analogues LC MS Image for CS