Detection and characterization of particles in the visible and subvisible size range is critical
in many fields of industrial research. Commercial particle analysis systems have proliferated …

Particles in biopharmaceutical formulations remain a hot topic in drug product development.
With new product classes emerging it is crucial to discriminate particulate active …

The presence of particles is a major issue during therapeutic protein formulation
development. Both proteinaceous and nonproteinaceous particles need to be analyzed not …

Formation of aggregates and particulates in biopharmaceutical formulation continues to be
one of the major quality concerns in biotherapeutics development. The presence of large …

Measurement and characterization of subvisible particles (including proteinaceous and non-
proteinaceous particulate matter) is an important aspect of the pharmaceutical development …

Particle detection and analysis techniques are essential in biopharmaceutical industries to
evaluate the quality of various parenteral formulations regarding product safety, product …

Measurement and characterization of subvisible particles (defined here as those ranging in
size from 2 to 100 μm), including proteinaceous and nonproteinaceous particles, is an …

The subvisible and visible particles present in a solution are often classified based on size,
and are quantified by the actual number of particles present rather than by weight or molar …

The analysis of particulates has been a longstanding challenge in biopharmaceutical drug
product development and quality control because the active constituents themselves may …

Abstract Nanoparticle Tracking Analysis (NTA) is an emerging technique for detecting
simultaneously sub-micron particle size distributions and particle concentrations of a …