Automating Pharmacokinetic Bioanalysis at Nanoliter-Scale: Strategies for Development, Validation and Transfer
Phamacokinetic (PK) bioanalysis presents challenges for method development and validation in supporting preclinical and clinical studies. Early in development, there is a need to support multiple candidates, multiple species and multiple programs. In regulated bioanalysis, more robust methods with higher throughput are essential for decisions in advancing project timelines. Application of the Gyros technology platform for PK bioanalysis provides versatility and flexibility at all stages of development in an automated, nanoliter-scale format. The webinar focuses on different strategies to consider in method development as well as validation and transfer to another group, particularly a CRO.
Detection of human IgG matrices: A universal approach
The new ‘Universal’ Gyrolab platform is designed to detect human immunoglobulin G (IgG) in any animal matrix to provide Pharmacokinetic (PK) data. This is enabled by the use of an inimitable ‘Universal’ capture reagent which does not cross-react with serum from mouse, rat, and the non-human primates marmoset, rhesus macaque, cynomolgus monkey and baboon, making it an ideal reagent for the use up to and including Dose Range Finding (DRF) studies. This ‘Universal’ capture reagent greatly reduces turn around time by eliminating a significant capture reagent screen step in method development.
With increasing pressure to develop high quality, fit for purpose assays within reduced periods of time, smaller companies with limited internal resources need to establish partnerships with other bioanalytical groups who have a proven track record in assay development and validation activities. At NovImmune, a process has been established to perform tool selection and development in-house and then to transfer the assay to a CRO for validation and clinical sample testing. The choice of CRO is based upon multiple criteria including expertise, availability of new technologies, cost and timelines. Herein is described the process of successful transfer and validation of a monoclonal antibody (mAb) PK Gyrolab assay from NovImmune (Geneva, Switzerland) to a CRO and the use of the Gyrolab Viewer software module for its support aspect during validation.