Application Note: Validated Quantitation and Activity Assay of Fab Molecule for Process Development and Quality Control

The group was able to develop a working Fab activity assay on the Octet^® RED system in less than a week. Relative to the overnight incubation and four-hour assay time of their ELISA protocol, the Octet assay provided an analysis time of only one hour per 96-well microplate, including sample preparation time. This Octet assay was used to monitor Fab activity for all process development studies. The assay was subsequently qualified for use in quality control in less than one month. This document describes the various steps involved in development and initial validation of the Octet assay and presents experimental results from Boehringer Ingelheim that demonstrate the value of Octet systems in process development and QC studies.

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