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Our work and case studies

Challenge: 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. 

Customer:

European Biotech Company 

Outcome:

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. 

Analysis of Insulins Case Study