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.
About the Authors
P. M. Isaykina
Moscow Technological University (Institute of fine chemical technologies)
Russian Federation
Russian Federation
V. P. Dolgova
Scientific Center of Russian Federation Research Institute for Genetics and Selection of Industrial Microorganisms
Russian Federation
Russian Federation
A. D. Ascretcov
Moscow Technological University (Institute of fine chemical technologies)
Russian Federation
Russian Federation
N. V. Orlova
Scientific Center of Russian Federation Research Institute for Genetics and Selection of Industrial Microorganisms
Russian Federation
Russian Federation
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Review
For citations:
Isaykina P.M., Dolgova V.P., Ascretcov A.D., Orlova N.V. QUANTITATIVE DETERMINATION OF HOST CELL PROTEINS (CHO) BY THE METHOD OF ENZYME IMMUNOASSAY IN THE PROTEIN ADALIMUMAB. Drug development & registration. 2017;(4):166-175. (In Russ.)
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