Practical Quantitative and Kinetic Applications of Bio-Layer Interferometry for Toxicokinetic Analysis of a Monoclonal Antibody Therapeutic

Dysinger, M.; King, L.E., 379(1-2), 30-41, J Immunological Methods, 2012

The authors present rationale and strategies for the development and analytical qualification of a BLI assay for the quantitation of a humanized antibody therapeutic in cynomolgus monkey plasma. They used an Octet QK system, a first-generation instrument based on BLI technology. Reference is made at several points in the publication to the Octet RED-type systems that are capable of higher sensitivity detection in comparison to the Octet QK system. Results of the qualification were compared to those of a validated ELISA used to quantitate the same therapeutic. Selectivity, matrix effect, and precision and accuracy were found to be similar between the two methods. The main difference between the two assays was in the dynamic range (0.1-10 μg/mL for ELISA vs. 0.4-50 μg/mL for BLI). A direct quantitation comparison of sample results for the two methods shows a high degree of agreement (r2=0.979, slope=1.017).

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