Abstract
One of the main requirements for the new vaccines being created is their safety in use, including the total protein content, which are one of the main indicators of the quality and safety of vaccines. This article presents the results of work on the comparative analysis of methods for determining the total protein in the active pharmaceutical substance (AFS) and also the bulk product of the vaccine "QazCovid-in ® .Determination of the total protein concentration was carried out by comparing the methods of Lowry, Bradford, commercial sets of Clini Test-BL and BSA Gold Protein. As a result of the determination of the total protein in the composition of the AFS by the classical Lowry method and the commercial CliniTest-BL kit, the highest values were obtained on average 616.67 and 589 μl/ml, and in the bulk product 51.11 and 47.38 μl/ml, respectively. The most minimal indicator of the total protein content of 38.39±0.000059 is shown by the method using the commercial BSA Gold Protein kit. The average values of total protein content showed the results obtained by the Bradford method and the determination of total protein by a commercial set of Clini Test-BL. The data obtained allow us to recommend the use of a set of Clini Test-BL for use in quality control, since this set is characterized by the ease and speed of the determination method, which is not inferior to the classical Lowry method. When determining the total protein content in the bulk product used to prepare the QazVac vaccine against COVID-19, the classical Lowry method showed the best result with a high degree of sensitivity.