Biological Activity Evaluation Method for Biopharmaceutical Compositions

Abstract

The invention relates to a biological activity evaluation method specific to a biological medicine composition. The method comprises the following steps: firstly, constructing a quantitative method specific to each protein component of the biological medicine composition based on the principles of an ELISA sandwich method; determining the common biological action mechanism of each protein component of the biological medicine composition and constructing the biological activity evaluation method based on the action mechanism; detecting the biological activity of the biological medicine composition mixed according to different proportions, taking the protein concentration of a certain single component as the benchmark, and recording the biological activity detection results of the biological medicine composition under different mixed proportion conditions and the EC50 value of a 4-parameter fitting curve. The method provided by the invention can be used for judging whether a certain component of the biological medicine composition generates inactivation according to the biological activity detection results or the changes of the EC50 value of the 4-parameter fitting curve, and can be used for the activity research and stability evaluation of the biological medicine composition.

Description

technical field [0001] The present invention relates to the field of biotechnology, in particular to a biological activity evaluation method, in particular to a biological activity evaluation method for biopharmaceutical compositions. Background technique [0002] With the continuous improvement of the level of biotechnology, including the continuous and rapid development of gene cloning technology, cell culture and purification technology, and bioanalysis technology, the research and development of biomacromolecular drugs has gradually replaced chemical drugs and small molecule drugs and has become a research hotspot in the field of pharmaceuticals. In 2015, 8 of the top ten drugs in global sales were biological drugs, and there were more than 4,500 biological drugs in the clinical research and marketing stages, which can be said to be a strong market and hot research and development. Domestically, biopharmaceuticals are listed as key breakthrough areas in the national phar...

AI Technical Summary

Problems solved by technology

The detection of impurity content is basically the same as that of conventional monoclonal antibody drugs; the detection of product purity needs to distinguish the two core components of the monoclonal antibody in the composition. In the process of developing the purity analysis method, not only the separation of impurity peaks, but also The separation effect of the two core components is more difficult to develop than conventional monoclonal antibody drugs; and the activity evaluation of the antibody composition is the most difficult: first, the targets of the two core monoclonal antibody components are different, and biological evaluation The methods may also be different. As traditional monoclonal antibody drugs, the two have their own bioactivity evaluation methods. When using their respective bioactivity methods to detect monoclonal antibody compositions, there may be synergy, or they may interfere with each other, making it difficult to evaluate the test results; Secondly, the protein concentration of the two needs to be tested and confirmed separately, and the protein concentration after the two are mixed cannot be simply used as the biological activity evaluation benchmark of the composition, because the mechanism of action of the two may be different; further, in the stability study, it is hoped that through The detection of the biological activity of the composition can distinguish and judge whether the activity of each component of the composition has decreased

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