Understanding the contribution of relevant factors to the analytical variability of the micro-
flow imaging (MFI) technique is of prime importance because of the significance of the …

Purpose During biopharmaceutical drug manufacturing, storage, and distribution, proteins in
both liquid and solid dosage forms go through various processes that could lead to protein …

Sub-visible particles (SVPs) in pharmaceutical products are a critical quality attribute, and
therefore should be monitored during development. Although light obscuration (LO) and …

Abstract The US and European Pharmacopeias require subvisible (≥ 10 and≥ 25 µm) and
visible particulate testing of therapeutics to ensure their safety and suitability for clinical use …

Flow-imaging microscopy is widely used in the biopharmaceutical industry to characterize
populations of subvisible (1-100 μm) particles due to high sensitivity and the ability to …

Purpose Sub-visible particles were shown to facilitate unwanted immunogenicity of protein
therapeutics. To understand the root cause of this phenomenon, a comprehensive analysis …

Although formation of subvisible particles (1-100 μm) during manufacturing and/or storage is
a major stability concern with protein therapeutics, particle numbers are often too low to …

Flow imaging microscopy (FIM) is widely used to characterize biopharmaceutical subvisible
particles (SVPs). The segmentation threshold, which defines the boundary between the …

Concentration and morphologic distributions of particle sub-populations is required to
ensure product quality of biopharmaceuticals. However, current pharmacopeial methods are …

Micro-flow imaging (MFItm) has been shown to be more sensitive than light obscuration (LO)
methods for measuring subvisible proteinaceous particles in protein formulations. Given the …