Analysis of Insulin Analogues Case Study
CASE STUDY: Analysis of Insulin Analogues
A client has developed new product to fulfil an unmet patient need. Pivotal clinical studies require highly sensitive, precise measurement of multiple insulin analogues from a small volume of plasma. Our existing methodologies have enabled successful proof of concept and non-regulated PK studies to be completed, but did not meet the precision necessary for regulatory acceptance.
European Biotech Company
Following a demonstration in the autumn, a new mass spectrometer was purchased, installed and verified for insulins analysis within four months, in time to meet the client’s timeline for a key clinical trial. Analysis for the trial commenced in the spring, and the system is now analysing samples around the clock.