Navigating the development and manufacturing of biopharmaceuticals is complex, especially when it comes to ensuring that drug formulations are stable and effective. A key challenge lies in detecting and characterizing subvisible particles (SVPs). Ranging from 1 µm to 100 µm in size, these tiny particles can cause severe health issues, from clogging capillaries to sparking life-threatening immune reactions.
Traditional methods for analyzing subvisible particles, such as light obscuration (LO) and flow imaging (FI), have limitations that make accurate particle identification difficult. LO counts particles, but cannot differentiate between particle types due to its reliance on low refractive index contrast. On the other hand, FI provides more detailed images and morphological data but struggles to fully identify the chemical makeup of particles. This inability to distinguish proteins from plastics or degraded polysorbates only adds complexity, underscoring the need for more sophisticated solutions.
Regulatory agencies now expect drug manufacturers to employ multiple, orthogonal methods to supplement traditional compendial techniques. Among these advanced techniques is Fluorescence Membrane Microscopy (FMM), a breakthrough technology exclusively available on Aura® particle analyzers. FMM offers high-throughput, low-volume identification of subvisible particles, providing an ultra-fast, 100% sampling efficiency. It can characterize everything from a single protein aggregate to tens of millions of particles across samples in under two hours.
In this eBook, we will explore how researchers can address these challenges through innovative techniques that go beyond simple particle counting and provide deep insights needed for the safe and effective development of biopharmaceuticals.
