Agile BioScience: Visualizing Particle Contaminants with Micro-Flow Imaging
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.
Our Approach:
- Advanced MFI Systems: We leverage the MFI 5000 series or comparable systems for high-quality particle imaging and analysis.
- 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.
- 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:
- Comprehensive Particle Characterization: Gain a deep understanding of particle types, quantities, and sizes in your product.
- Troubleshooting Support: Identify the root causes of particulate matter and optimize manufacturing processes to minimize contamination.
- 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.
Characterization
- Dynamic Light Scattering (DLS)
- Liquid Chromatography
- Circular Dichroism (CD)
- SEC-MALS
- SV-AUC
- Fourier-Transform Infrared (FTIR)
- Differential Scanning Calorimetry (DSC)
- Secondary, Tertiary and Higher Order Protein Structure
- CE-SDS
- Image Based Capillary Electrophoresis
- Intact Molecular Weight Analysis
- Oligosaccharide Profiling Services
- Disulfide Bond Mapping Services
- N- and O-linked glycosylation services
- Peptide Mapping Services
- C-terminal Sequencing
- N-Terminal Sequencing
- Amino Acid Analysis
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