Many reports have shown the negative impact that aggregates and other particles have on the efficacy, safety, and immunogenicity of protein therapeutics.
FDA regulations strongly recommend in-depth characterization of sub-visible particles in protein therapeutics. New recommendations are specifically targeted at the characterization of sub-visible particles in the 2 to 10 µm range.
FlowCam helps you accurately and reliably analyze your formulation to ensure quality and meet regulatory requirements.
Most protein therapeutics contain a variety of particles, including proteins, silicone droplets, and contaminants in a variety of shapes. Light obscuration, which is typically used to comply with USP <788>, cannot differentiate one particle from another, nor fully characterize particles because the technology assumes all particles are spherical.
The FlowCam imaging particle analysis system allows you to simultaneously determine particle shape, type, and size distribution, plus provides you with an image of each particle measured.
Image quality is extremely important when characterizing, identifying, and differentiating particles such as protein aggregates, silicone oil, air bubbles, and other contaminants, and it is essential for accurate sizing measurements. Blurry images lead to poor characterization of particles and can affect your particle size distribution. Only the FlowCam has the image quality necessary to accurately count, size and classify particles in the 2 - 10 µm range.
It's challenging to characterize protein aggregates because they are transparent. Light obscuration instruments often mis-characterize them or don't see them at all.
FlowCam can differentiate transparent protein aggregates from other particles in your formulation, like silicone droplets - as with all flow imaging instruments, proper settings are critical to your results. That is why the FlowCam is delivered to you already optimized for characterizing protein aggregates.
Data is one thing - actionable information is another. With FlowCam, you get instant access to all images captured. Plus with VisualSpreadsheet® software, you can efficiently interact with your data, and extract the information you need quickly and easily.
Here's how data is captured when a therapeutic protein formulation is analyzed with the FlowCam.
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