Chiral Assay Development, Qualification & Validation

Chiral Assay Development, Qualification & Validation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

More than half of the drugs currently marketed contain a chiral center.  The inclusion of a chiral center can permit a drug molecule to properly fit into a receptor for optimum therapeutic effect.   Therefore, stereospecific assays are essential for (1) racemate drug mixtures to document any pharmacokinetic differences between the isomers and (2) an isomericly pure drug to confirm if racemization might occur in vivo.

KCAS has developed and validated for a wide range of chiral assays in biological matrices, ranging from NSAIDs to therapeutic peptides by LC-MS/MS.    We have extensive experience in developing and optimizing robust, GLP compliant methods of various chiral compounds in a wide range of matrices.  Most recently we established a diastereomer assay for a ghrelin-like peptide for NDA submission to the European Medicines Agency (EMA).

[Link the Anamorelin Poster].

 

Our scientists have notable expertise in this area. Key is knowing how to establish robust assays capable of retaining sufficient resolution over time.