Early pk studies on recombinant proteins or peptides

During the development of drugs, in vitro Early PK analysis is performed on therapeutic drug candidates to evaluate parameters such as drug time life, metabolism or therapeutic window determination.

Here, the goal was to perform multiplex bioanalysis on 2 commercial insulin analogues: lispro and glargine. Due to the similarities in the amino acids sequence between these 2 proteins, Ligand Binding Assays (LBAs) are not suitable to specifically detect and quantitate them. Through a LC-MS multiplex analytical method, we were able to obtain these data. Moreover, within the same analysis, the 2 main metabolites of lispro and glargine were also analysed and quantitated.

The first step was to validate the detection specificity of each protein and their associated metabolites with any enzymatic digestion. After incubation at 37°C in serum, different time points were monitored through a simultaneous detection of lispro, glargine and their metabolites over time.

Thanks to this method development, scientists could be able to

• Quickly determine the effects of biological environment on therapeutics compounds
• Select the best candidates
• Improve the development of the drug formulation
• Support pre-clinical and clinical studies

You could have an overview of our full work on insulin analogues and associated metabolites here