Regulators question whether particles that they can't see hurt patients. Protein aggregates in biological drugs have the potential to trigger an immune response in the patient, which, at the very ...

Imagine seeing bits of glass, rubber, or metal floating in a vial of medicine that is about to be injected into your arm. Small shards and scraps from the manufacturing process or storage containers ...

Flow imaging microscopy can be used to identify particulates and their sources. Subvisible particles (SVP) are a concern for biologic-based drugs. Some technologies can detect but not identify ...

Subvisible particle analysis is a key predictor of protein drug stability and a key formulation, quality metric. However, current methods use large volumes of precious protein solutions and are labor- ...

Fig 1. Archimedes harnesses the technique of resonant mass measurement for detection, quantification and identification of protein aggregates in the subvisible range Archimedes is a highly innovative ...

Halo Labs is an innovator in drug product characterization and subvisible particle analysis providing unprecedented product quality insights to improve patient safety. Starting with the launch of its ...

Strategies for monitoring subvisible particles in biopharmaceutical formulations are central to developing and manufacturing safe, effective drug products. This webinar will introduce flow imaging ...

FlowCam uses Flow Imaging Microscopy (FIM) to characterize particles in liquid biopharmaceutical formulations. There are several important features of FIM instruments to keep in mind if you are ...

In order to quantify the count and size of subvisible particles in eye care products, the USP <789> test is carried out. This consists of utilizing a light obscuration particle counter and counting ...

Have you met MFI? Micro-flow imaging is a new solution for measuring and visualizing subvisible particles in biopharmaceutical products. As these small (1-1,000 micron) particles are considered a ...

Michael Caves, India Business Development Manager, Malvern Instruments, in this article elaborates how Archimedes can be used to detect and quantify the formation of protein sub-visible particles and ...