Method development for quantitative monitoring of monoclonal antibodies in upstream cell-culture process samples with limited sample preparation - An evaluation of various capillary coatings.

ABSTRACT: Monoclonal antibodies (mAbs) have become an important class of biopharmaceuticals used for the treatment of various diseases. Their quantification during the manufacturing process is important. In this work, a capillary zone electrophoresis (CZE) method was developed for the monitoring of the mAb concentration during cell-culture processes. CZE method development rules are outlined, particularly discussing various capillary coatings, such as a neutral covalent polyvinyl alcohol coating, a dynamic successive multiple ionic-polymer coating, and dynamic coatings using background electrolyte additives such as triethanolamine (T-EthA) and triethylamine. The dynamic T-EthA coating resulted in most stable electro-osmotic flows and most efficient peak shapes. The method is validated over the range

SUBMITTER: van der Burg D 

PROVIDER: S-EPMC10099398 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature