ResourceDrug discovery > Basic Research
Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development and Quality Control
1 Jun 2017This application note presents a robust assay developed to measure the biological activity of an antibody fragment (Fab) molecule for in-process testing as well as stability and lot release testing in the Quality Control (QC) department of the analytical group at Boehringer Ingelheim, Fremont, USA.
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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. Process DevelopmentProcess development aims to optimize the performance of manufacturing systems. This involves the assessment of quality and efficiency of both processes and products. This is particularly important in the scale-up of chemical processes.Method ValidationMethod validation is the process used to prove that the analytical procedure used for a particular test is capable of providing suitable data.