Recommendations for ell Banks Used in GXP Assays

摘要

Cells and cell-derived reagents form the basis of an operationally challenging class of test methods used in execution of product potency testing (stability and lot release), assessments of pharmacokinetic/ pharmacodynamic (PK/PD) profiles, detectionof antidrug antibodies (ADAs) or neutralizing antibodies (NAB), and characterization and comparability testing of biopharmaceutical products. Frequently, cell-based assays provide the only measurement of the tertiary/quaternary structure of each batch ofproduct at the time of lot release and during stability testing to assist in determining product shelf-life. Cultured cells themselves are often used to generate monoclonal antibodies (MAbs), enzymes, or substrates for use as critical reagents in othertypes of tests, including ligand binding and enzymatic assays. In all these applications, the cells serve as highly critical, highly complex "reagents" that require distinct characterization and control measures to ensure operational consistency over time.