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Sabrina Lory, Head of the Bioanalytical Assay Laboratory, NovImmune, presented ‘Developing fit for purpose assays using the Gyrolab platform' at the International Gyrolab Seminar, USA.
In this seminar, Sabrina describes how Gyrolab platform solved a problem of limited sample volume for analyzing a fully human IgG1 antibody-based therapeutic in clinical samples in fit-for-purpose assays. A pharmacokinetic (PK) assay was developed and optimized using < 5 microliters of sample. Pharmacodynamic (PD) and anti-drug antibody (ADA) assays were also developed for further optimization at a contract-research organization (CRO) using the same low sample volume of 5 microliters.
The Gyrolab assays for PK and PD showed better sensitivity and lower sample volume required compared to ELISA, and the ADA assay also required less sample volume than ELISA however this assay was transferred to the CRO for further development.