Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development and Quality Control
The analytical group at Boehringer Ingelheim, Fremont, USA needed a robust assay to measure the biological activity of an antibody fragment (Fab) molecule for in-process testing as well as stability and lot release testing in their Quality Control (QC) department.
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.