Determination of Protein Aggregation from the Concentration Dependence of Delta G

摘要

The present invention relates to, among other things, methods and systems for recognizing and characterizing protein aggregation processes at the earliest possible time and use of such new methods and systems for (1) the identification and selection of protein formulations that minimize aggregation and extend long-term stability and (2) the identification of protein variants with the lowest tendency to aggregate.

主权项

1. A method for determining the amount or fraction of protein aggregation in a solution based upon said solution's protein concentration, comprising:
providing a plurality of first solutions comprising increasing concentrations of a protein; measuring an observable property for each solution in said plurality of first solutions; determining ΔG for the conformational stability of said protein at each concentration in said plurality of first solutions based on said observable property; creating a correlation between ΔG and each concentration of said protein; and using said correlation to determine the amount or fraction of said protein that is aggregated.