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

Claim 4:
5. 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) interrogating the sample as the sample passes through a sensing zone of the particle analyzer, the sample comprising at least one fluorescent dye,
wherein the interrogation includes one or more wavelengths that can interrogate the size standard, and excite the at least one fluorescent dye, and
wherein the at least one fluorescent dye includes a first fluorescent dye that stains a non-proteinaceous material in a manner that distinguishes the non-proteinaceous material from a proteinaceous material;

c) 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 fluorescence parameter includes a first fluorescence parameter representing presence of the non-proteinaceous material based upon fluorescence intensity emitted from the first fluorescent dye; and

d) analyzing the data to define the particle size and presence of the non-proteinaceous material in order to determine a size and presence of non-proteinaceous subvisible particles, thereby characterizing the population of subvisible particles in the sample.