Determining titer of biological agent, useful e.g. for gene therapy vectors or vaccines, is based on measuring reaction with cells at constant concentration, over a specified time period

摘要

Determining the titer of a biological agent (I) that interacts with living cells, is new. Determining the titer of a biological agent (I), that interacts with living cells, comprises: (a) at unknown starting concentration C, is incubated with cells at constant concentration D, and the intensity, i, of the signal resulting from (I)/cell reaction is measured as a function of time, t; and (b) the time (tb) corresponding to a signal intensity i = b (where b is between bmax and bmin, corresponding to i values at the point of inflexion of the i = f(t) curve for maximum and minimum concentrations of a reference (I) for which the curve tb = f(C) has been predetermined) is determined. The concentration C is then determined from tb = f(C), where. An Independent claim is also included for a kit for measuring or detecting (I) comprising cells at concentration D; reference compound at known concentration C and reference curve tb = f(C).