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 sometimes creep into liquid-based therapeutics, posing significant health risks.1 The problem is that these particles are too tiny to be visible to the naked eye.
Protein therapeutics add another layer of complexity to the problem. Components in protein therapeutics may form aggregates in response to pharmaceutically-relevant time scales or under stress conditions. Prolonged storage, container choice, shipping and handling, changes in air, light, temperature, or changes in state from solid to liquid, which occurs during thawing, may induce the formation of subvisible protein aggregates.2 With so many possibilities for aggregation and particle contamination, it is no surprise that subvisible particle size ranges by over one million-fold!3
Scientists use manual microscopy and membrane microscopy to detect and ...
