Record Type: Analysis
Insulin analogs are structurally similar to human insulin except for minor amino acid modifications to change the pharmacokinetic (PK) properties. Monitoring and differentiating insulin analogs can improve the outcome in drug development and clinical studies.
The bioanalytical assay for insulin analogs uses immunoaffinity cleanup to achieve LLOQs of 200 pg/mL. Furthermore, an LC-MS/MS method uses solid phase extraction (SPE) instead of immunoaffinity to enable a higher throughput assay and overcoming some selectivity challenges.