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Bioanalytical Research Method

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With the rapid development of the pharmaceutical industry, the research of biotechnology drugs has also entered a higher level of platform. Biotechnology drugs refer to therapeutic drugs produced through recombinant DNA technology or other innovative biotechnology-based biotechnology, which mainly include cytokines, plasminogen activators, recombinant plasma factors, growth factors, antibodies, vaccines and oligonucleotide drugs It is clinically used in the treatment of serious diseases such as malignant tumors, cardiovascular and cerebrovascular diseases, diabetes, and rheumatoid arthritis. Biotechnology drugs have significant therapeutic effects and less side effects, and have gradually become the focus of new drug development. With the promulgation and implementation of the Pharmacopoeia of the People’s Republic of China (2020 edition), biopharmaceutical analysis and testing technologies are constantly updated and improved, and the quality control of biotech drugs will be greatly improved. The analysis and testing standards will gradually be in line with international standards, and the quality of drugs will reach international standards. Level. This article combines the current development trend of science and technology to explain the methods of analysis and detection of biotechnology drugs, and looks forward to making certain contributions to the long-term development of biotechnology drug analysis and detection technology.

Biotechnology drug analysis is a comprehensive subject that integrates research, detection and control. It mainly analyzes and identifies the chemical components, configurations, and morphological characteristics of various biotechnology drugs, and detects drug quality and various groups in different drugs. Sub-content, content of pharmacokinetic degradation products. Biotechnology drugs, especially protein drugs, due to their low stability, are prone to break or fold in part of the peptide chain, leading to failure of protein agglomeration. It should be used in all aspects of raw material drug production, biologics storage, and transportation to clinical application. Carry out product quality analysis and testing, comprehensively monitor the quality of biotechnology drugs, and ensure the safety, rationality and effectiveness of patients’ medications.

The main work of biotechnology drug analysis and testing includes drug analysis and testing, impurity and safety testing, amino acid drug analysis and testing, peptide and protein drug analysis and testing, enzyme drug analysis and testing, lipid drug analysis and testing Testing, analysis and testing of nucleic acid drugs, analysis and testing of carbohydrate drugs, quality control of genetic engineering drugs.

Analysis and detection methods mainly include chemical methods, instrumental analysis methods and biological verification methods. The routine steps of analysis and testing are as follows: review→sampling→identification→inspection→content test→recording→issuing test report.

(1) Chemical method

Chemical analysis and detection of biotechnology drug component content, mainly including gravimetric method and titration method. The gravimetric method is a quantitative method for calculating the content of the target substance in the analyte based on the quality of the relevant element and compound by accurately weighing and quantifying the analyte. Titration is a routine method used in chemical laboratories. The measurement data is accurate but the operation is cumbersome. Amino acid drugs are mostly determined by titration.

(2) Instrumental analysis method

The instrumental analysis has high sensitivity and is used for trace and trace analysis and detection, including optical method, electrochemical method, chromatography, electrophoresis, enzymatic analysis and immunoassay. With the continuous research and advent of modern precision analytical instruments, the analysis and detection methods for biotechnology drugs have become more precise and complete.

a. Gel electrophoresis method sodium dodecyl sulfate-polyacrylamide gel electrophoresis method (SDS-PAGE)

Gel electrophoresis sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) is a commonly used separation and detection method for protein biotechnology drugs, and its migration rate depends on the molecular weight. SDS-PAGE is suitable for the separation and detection of oligomeric proteins with a molecular weight of 5 to 500kDa. The covalent bond of this type of protein is relatively stable in a polyacrylamide environment. The detection range of molecular weight can be expanded by adjusting the gradient gel or a specific buffer system. The limitation of SDS-PAGE lies in the narrow detection range. Because the heating process may cause abnormal degradation of protein drugs in K12, its quantitative accuracy is not good.

b. Ultracentrifugation Ultracentrifugation (AUC)

Ultracentrifugation Ultracentrifugation is based on the sedimentation characteristics of different biological drugs (molecular morphology, configuration, molecular weight), the sample to be tested is centrifuged by an ultracentrifuge, and the detection system dynamically monitors the sedimentation of drug molecules, and analyzes and detects the Test the physical and chemical properties of the sample. The sedimentation balance method and sedimentation rate method belong to the category of ultracentrifugation. The sedimentation equilibrium method can obtain the relevant stoichiometric information of biopharmaceutical molecules; the sedimentation rate method can obtain the molecular volume and configuration of the molecule and other hydrodynamic properties, which is a common analysis method for the detection of oligomeric proteins.

c. Optical turbidity method

Studies have shown that the scattering angle and intensity of the scattered light are related to the particle size and morphology of the material in the suspension. The biotechnology drug is formulated into a suspension, and the degree of scattering of the light passing through the solution is measured to analyze and detect the physical and chemical parameters of the drug. The turbidity method is a method for measuring the turbidity of a solution by using the Rayleigh scattering characteristics of suspended particles in a solution. The protein preparations of biotechnology drugs can be used to quickly determine the concentration of protein and the size of the suspended particle size by turbidimetry, which is widely used in the analysis and detection of the degree of polymerization of protein liquid preparations.

d. Chromatography

Chromatography Chromatography has the advantages of high sensitivity, accurate quantification, and simultaneous detection of the content of the analyte in the mixed components. It is difficult to replace its position in analysis and detection research. High performance liquid chromatography (HPLC) uses high-efficiency stationary phases, high-pressure mobile phases and online detection technology to analyze, identify, and detect the active ingredients of biotech drugs without affecting their molecular configuration and biochemical activity. my country clearly stipulates in the approval process before clinical trials of new drugs: HPLC testing should be the first choice for pharmacokinetics experiments of new drugs.

LC-MS/MS combined with mass spectrometry can achieve more efficient separation due to its higher sensitivity. In addition, high-resolution mass spectrometry is also a powerful tool for protein analysis in recent years.

(3) Biological test method

Immunoassay biotechnology drugs are immunogenic, which provides a corresponding platform for the application of immunoassay. Enzyme-linked immunosorbent assay (ELISA) is a commonly used analysis method in biotechnology drug immunoassays with precision and sensitivity, good stability, high degree of equipment automation, batch detection, and no radiation hazards.

Both immunoassays and bioassays are interfered by factors such as active metabolites, biological matrix, and inhibitory factors in serum or restricted by their characteristics, and cannot fully analyze and detect the complete information of the degradation process of biotech drugs in the body.

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