The Laboratory of Quality Control of Immunobiological Drugs

The Laboratory of Quality Control of Immunobiological Drugs operates in the Republican Scientific and Practical Center for Epidemiology and Microbiology. The laboratory is accredited in the Accreditation System of the Republic of Belarus for compliance with the requirements of STB ISO / IEC 17025. The laboratory conducts testing of biological drugs (vaccines, toxoids, serums, immunoglobulins, interferons, probiotics, drugs based on monoclonal antibodies, allergens, etc.) also testing of quality control methods for medicines at the stage of their state registration (re-registration, making changes to the registration dossier).

The equipment and capabilities of the laboratory allow testing of drugs and pharmaceutical substances using modern methods for the following indicators:

1.«Identity» (high performance liquid chromatography, thin layer chromatography, ELISA, hemagglutination inhibition, polyacrylamide gel electrophoresis, agarose gel electrophoresis, isoelectric focusing, absorption spectrophotometry, fluorimetry, a biological method using cell cultures);

2. «Sterility» (methods of membrane filtration and direct seeding);

3.  Bacterial endotoxins "(gel-clot technique, a chromogenic kinetic method);

4. "Activity" (high performance liquid chromatography, ELISA, hemagglutination inhibition, polyacrylamide gel electrophoresis, agarose gel electrophoresis, isoelectric focusing, absorption spectrophotometry, fluorimetry, single radial immunodiffusion, biological method using cell culture);

5."Quantitative determination" (high performance liquid chromatography, absorption spectrophotometr ia, fluorimetry, polyacrylamide gel electrophoresis, agarose gel electrophoresis);

6. “Abnormal toxicity” (using mice and guinea pigs);

7. “Pyrogenicity”, “pH”, “Chromaticity”, “Transparency”, “Osmolarity”, “Invisible Particles” (determine the particle size by laser diffraction);

8. "Purity" (high performance liquid chromatography, absorption spectrophotometry, fluorimetry, polyacrylamide gel electrophoresis, agarose gel electrophoresis);

9. "Total protein" (absorption spectrophotometry, fluorimetry);

10 “Disintegration”, "Molecular weight distribution" (size exclusion chromatography).