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.