Characterization of Subvisible Particulate Matter in Biopharmaceuticals by Flow Imaging Method

User Benefits

- It is possible to evaluate using the flow imaging method, which is included as reference information in USP and JP. - The sample volume for measurement using iSpect DIA-10 is small. (minimum measurement amount: 50 μL, dead volume: 50 μL or less) - The microcell minimizes missed particles (imaging efficiency: 90% or higher).

Introduction

Biopharmaceuticals possess high specificity and efficacy; however, they are more susceptible to stress and prone to aggregation compared to small molecule drugs. The occurrence of aggregation can not only lead to reduced or lost efficacy but may also cause side effects due to immune responses. For the evaluation of particulate matter, such as aggregates in biopharmaceuticals, the light obscuration method (LO) is widely used, as it is established as a testing method in the United States Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP). In recent years, there have been reports of evaluations using flow imaging method (FI), which has higher sensitivity to highly transparent particles and allows for particle classification from images, compared to light obscuration method. This method is also included as reference information in both USP and JP. iSpect DIA-10 Dynamic Particle Image Analysis System is an analysis device based on the FI method, which requires a small sample volume and has an optical system that minimizes the chances of missing particles, making it suitable for the characterization of subvisible particulate matter in biopharmaceuticals. This article introduces an example in which the size and concentration of subvisible particulate matter in a protein solution were characterized by using the iSpect DIA-10.

March 5, 2025 GMT