Patent ID: 11921117
Assignee: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Field: Measurement (Instruments)
Classification: CPC G  C | IPC C  G

Claim 0:
1. A method of characterizing a population of subvisible particles in a sample, the method comprising the steps of:
a) calibrating a particle analyzer using a size standard;
b) adding a fluorescent counting standard and at least two dyes to the sample, wherein the at least two dyes comprise a first dye that stains a non-proteinaceous material in a manner that distinguishes the non-proteinaceous material from a proteinaceous material, and a second dye that stains a physical property of the non-proteinaceous material in a manner that distinguishes a non-proteinaceous material having the physical property from a non-proteinaceous material not having the physical property;
c) interrogating the sample as the sample of step b) as the sample passes through a sensing zone of the particle analyzer, wherein the interrogation includes one or more wavelengths that can interrogate the size standard, interrogate or excite the fluorescent counting standard, and interrogate or excite the at least two dyes, and
d) collecting data from at least one light scatter parameter and at least one fluorescence parameter, wherein the data collected from the at least one light scatter parameter represents a particle size based upon the size standard calibration, and wherein the data collected from the at least one parameter includes a first parameter representing presence of a non-proteinaceous material based upon intensity emitted of the first dye, a second parameter representing a particle number based upon fluorescence intensity emitted from the fluorescent counting standard, and a third parameter representing presence of a non-proteinaceous material having the physical property based upon intensity emitted from the second dye; and
e) analyzing the data to define the particle size, the particle number, presence of the non-proteinaceous material, and presence of the physical property in order to determine an absolute number and size of non-proteinaceous subvisible particles with and without the physical property, thereby characterizing the population of subvisible particles in the sample.