FIELD: biotechnology.
SUBSTANCE: invention is a method of controlling autoactivation of factor VII or its analogue and a method of prevention of cleavage of activated factor VII or its analogue. The methods comprise measuring the initial concentration of factor VII/VIIa or its analogue. The initial part of activated factor VII or its analogue is measured. The reaction time of activation of factor VII or its analogue is calculated by correlating the values measured at the abovementioned steps, with the value of the required part of activated factor VII or its analogue. The reaction of activation of the factor VII is carried out at pH of from 6.0 to 8.0. The reaction is terminated by reducing pH to the value below about 6.0.
EFFECT: invention enables to determine the optimum reaction time to achieve the desired levels of the modified factor VII or its analogue, to obtain a purer protease product, to reduce the cost of manufacturing base.
15 cl, 5 dwg, 1 tbl, 2 ex
