Sub-visible particles are an obligatory critical quality attribute of all bio-pharmaceutical products intended for infusion or injection because they affect product stability, effectiveness and safety. However, proteinaceous particles are found in all therapeutic protein products to some degree. Therefore, particle monitoring is an essential control strategy to ensure quality and safety in biotherapeutic development. Learn how scientists determine the number and size of these particles, what technologies they use, and where these methods are limited.
“Revolutionizing analytical testing to benefit people’s health” – this is the core idea behind Bionter and the motivation for its founder, Tobias Werk. It is a mission that focuses on the fundamental goal of human health. As an innovative start-up, we strive to be a world class provider of particle counters that are tailored to the pharmaceutical and biotechnology industries. Take a look behind the scenes of Bionter, our people and ambitions – and discover more about what drives us forward.