QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB

Abstract

Is necessary to ensure thorough purification of the target proteins, since the presence of host cell proteins (HCP) from CHO cells in the final product is fraught with a number of negative consequences. Thus, it is has to reduce the contamination of HCP to minimum levels. A comparison of the immunoenzymatic assays of the second and third generations of Cygnus technologies for the quantification of host cell proteins (CHO) in a monoclonal antibody adalimumab was done. It was found that a kit of the 2nd generation does not show the true level of the host cell proteins, underestimating the result. In this connection, it becomes necessary to confirm the validity of the method for determining the total quantity of host cell proteins (CHO) by a set of 3rd generation in adalimumab substance according to the following analytical characteristics: system suitability test, specificity, limit of detection, limit of quantitation, hook capacity, precision.

Keywords

• адалимумаб
• моноклональные антитела
• иммуноферментный анализ (elisa)
• белки клеток хозяина (cho)
• валидация