Abstract
A method for determining the specific bactericidal activity of the gel with the recombinant modified endolysin of the bacteriophage ECD7 has been developed. Bacterial strains to determine the specific bactericidal activity were selected and acceptance criteria were determined. The developed methodology was validated according to the indicators “Specificity”, “Accuracy” and “Intermediate precision”. The developed method has been successfully validated and is suitable for determining the specific bactericidal activity of a gel with a recombinant modified endolysin.
Highlights
Biotechnological substances and drugs are complex products, the quality indicators of which can vary from batch to batch depending on many external and internal factors.In this regard, approaches and requirements for determining the quality of biotechnological products differ from those for chemicals
Biotechnological products often lack a correlation between their quantitative content and biological activity (the ability of a product to cause a certain biological effect in a biological system), and the determination of the quantitative content of a particular product does not indicate its quality [1]
The quality indicator "Assay" for a biotechnological product is replaced by the indicator "Specific activity", which indicates the biological effect characteristic of a given substance or drug [1]
Summary
Biotechnological substances and drugs are complex products, the quality indicators of which can vary from batch to batch depending on many external and internal factors (temperature, humidity, pH, production conditions, used producer strains, etc.).In this regard, approaches and requirements for determining the quality of biotechnological products differ from those for chemicals. Biotechnological products often lack a correlation between their quantitative content and biological activity (the ability of a product to cause a certain biological effect in a biological system (organism, cell culture, etc.)), and the determination of the quantitative content of a particular product does not indicate its quality [1]. The quality indicator "Assay" for a biotechnological product is replaced by the indicator "Specific activity", which indicates the biological effect characteristic of a given substance or drug [1]. Specific activity is determined according to a method developed considering the characteristics of the analyte and the biological effect that it should have. The aim of this work is to validate the method for determining the specific activity of a gel containing recombinant modified endolysin (an enzyme synthesized by a bacteriophage at the end of the lytic cycle and capable of destroying the cell wall of gram-negative and some gram-positive bacteria) LysECD7-SMAP [2]
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