Recorded Webinar from December 18, 2018
Developing and validating a Gyrolab® ADA assay to address drug tolerance and small sample volume
Immunogenicity is a challenge that may reduce a drug’s efficacy and even cause adverse events in subjects. Anti-drug antibody (ADA) assays are required for non-clinical and clinical studies to report the occurrence of immunogenicity in subjects. Accurately detecting ADAs can explain oddities in a PK profile and may indicate whether or not neutralizing ADAs may be present, reducing a drug’s efficacy.
Residual drug can interfere in bridging ADA assays, resulting in false negatives in samples that contain ADA. Serial sampling in mice allows for a full profile of a single mouse, but introduces the issue of small sample volume for performing analysis. To address the issues of drug tolerance and small sample volume, an ADA assay for CD-1 mouse plasma was developed and validated on the Gyrolab workstation to utilize minimal sample volume while obtaining 72.9 ng/mL sensitivity with 200 µg/mL of residual drug. This presentation walks through the steps taken to successfully develop a Gyrolab bridging ADA assay and the challenges that were surmounted in the development process.
Senior Associate Scientist
Katrina Olson is a bioanalytical scientist with 9+ years between preclinical contract research and the biotech industry. She has extensive background and hands-on experience developing and managing autoimmune models in both mice and rats. Over the last couple of years, she has turned her focus to assay development using MSD and Gyrolab platforms to develop and validate robust PK, ADA, and NAb assays. Katrina received both her BS and MS in biochemistry from the University of New Hampshire.