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Extended sensitivity of biotherapeutic pharmacokinetic (PK) & biomarker immunoassays
Thursday 18th March | 16:00 GMT (UTC+0)
Learn about the application of microfluidic, nanoliter-scale Gyrolab immunoassay platform for ligand-binding assays. Understand the advantages of the Gyrolab Bioaffy 4000 CD for extending assay sensitivity in pharmacokinetic and biomarker analysis. Understand specific applications for MDBs and biomarker applications and the use of Gyrolab Bioaffy 4000 CD
Gyrolab Bioaffy 4000 CD: Extending Immunoassay Sensitivity in a Microfluidic Platform
Gyrolab immunoassays using a CD-based, nanoliter-scale, and automated flow-through affinity column approach are robust, have a broad dynamic range, and use very small amounts of precious sample for PK, anti-drug antibody (ADA), biomarker, and affinity applications. Introduction of the Gyrolab Bioaffy 4000 CD extends sensitivity for these applications.
John Chappell, BSc CChem CSci FRSC, has 25 years of experience in the Contract Research industry supporting both preclinical and clinical drug development. He is a Fellow of the Royal Society of Chemistry and was involved in the AAPS Biosimilar Committee that has prepared papers on Pharmacokinetic and anti-drug antibody assays.
Improving Existing Multidomain Biotherapeutic (MDB) PK Assay with Gyrolab 4000 CD
Development of a multidomain biotherapeutic (MDB) pharmacokinetic assay on Gyrolab platform required higher sensitivity, leading to the evaluation of the Gyrolab Bioaffy 4000 CD for this purpose. Switching the MDB PK assay from 1000 to 4000 CD successfully improved sensitivity 3-fold, with binding profiles supporting the higher affinities on 4000 CD. Remaining selectivity issues were observed, but were drug-related and not CD related.
Carina is a Senior Scientist at EMD Serono in the DMPK/NBE group for over 4 years. She has over 15 years of experience in the non-clinical and clinical GLP/GRP space, in running sample analysis, validations, and development of PK, ADA and nAb immunoassays. Carina is highly skilled in assay development of ligand binding assays utilizing an array of instrumentation including MSD, Gyrolab and Quanterix Simoa.
Development of a sensitive assay for detection of a serum biomarker using Gyrolab Bioaffy 4000 CDs.
Analysis of serum biomarkers can prove challenging for a number of reasons. For those biomarkers that are present in low endogenous levels in the serum, one obvious challenge is developing an assay with sufficient sensitivity. Using the existing Gyrolab instrument, F-star have been able to use the new Bioaffy 4000 CDs to achieve a sensitive assay for the detection of a soluble serum biomarker, improving the ability to measure this analyte in serum samples.
Claire Seal is a Principal Scientist who has been leading the Bioanalytical/Biomarker Development Team at F-star Therapeutics, Cambridge for the past three years. This includes developing PK, ADA and biomarker methods for all F-star projects, and validation for non-regulated analysis at F-star or transfer to contract research organisations (CROs). Prior to this, she was a Senior Scientist at LGC, Newmarket for seven years, specialising in Method Development and also acting as a regulated Project Manager for GLP/GCP studies. This involved working with a wide variety of clients and therapeutics on PK, ADA, nAb and biomarker assays. Claire has a PhD from the University of Cambridge and a BSc in Biochemistry from the University of Reading.