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Agile BioScience: Visualizing Particle Contaminants with Micro-Flow Imaging
Micro Flow Imaging (MFI)
The instructional chapter USP<1787> mentions MFI as a possible orthogonal technique for subvisible particle analysis in addition to light obscuration. Micro-Flow Imaging (MFI) is an essential tool for characterizing sub-visible particles in biopharmaceuticals, ensuring product purity and patient safety. Agile BioScience employs MFI to provide comprehensive particle analysis services.
Why MFI Matters:
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Direct Visualization: MFI captures high-resolution images of particles, allowing for identification and morphological analysis.
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Sizing and Quantification: Determines the size distribution and concentration of particles across a wide range.
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Particle Identification: MFI, coupled with morphological analysis and other techniques, aids in distinguishing protein aggregates from foreign contaminants.
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Regulatory Compliance: Supports thorough particle characterization in line with regulatory guidances.
Our Approach:
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Advanced MFI Systems: We leverage the MFI 5000 series or comparable systems for high-quality particle imaging and analysis.
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The digital images of the particles present in the sample are processed by image morphology analysis software that allows their quantification in size and count.
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Data-Driven Guidance: We interpret MFI data to provide insights into the nature of particles and potential sources of contamination.
Benefits of Choosing Agile BioScience:
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Comprehensive Particle Characterization: Gain a deep understanding of particle types, quantities, and sizes in your product.
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Troubleshooting Support: Identify the root causes of particulate matter and optimize manufacturing processes to minimize contamination.
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Confidence in Product Purity: Ensure your biopharmaceuticals meet stringent quality standards for patient safety.
Contact us to learn how MFI can safeguard your biopharmaceutical products.
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