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Ensuring the quality and safety of biopharmaceuticals demands vigilant monitoring of sub-visible particles. Agile Bioscience is at the forefront of this critical task, equipped with the ProteinSimple MFI 5200 and image analysis software. This powerful combination unlocks superior particle characterization for our clients.
Why Sub-Visible Particles Matter
Sub-visible particles (generally between 1µm and 100µm in size) can be intrinsic to the product or introduced during manufacturing. They have the potential to trigger immunogenic responses, posing risks to patients. Regulatory agencies are increasingly focused on sub-visible particle analysis due to these quality and safety concerns.
The Power of the MFI 5200 System
The MFI 5200 with image analysis software offers unparalleled advantages in sub-visible particle characterization:
Image-Based Detection: Provides visual confirmation of particles, enhancing data confidence and reducing ambiguity.
Morphological Analysis: Measures particle size, shape, and other morphological features, enabling classification and potential identification of particle sources.
Sensitivity Beyond Traditional Methods: Detects even translucent and transparent particles that light obscuration techniques can miss, ensuring a more comprehensive analysis.
Automated Sampling: Streamlined operation enables high-throughput analysis and walk-away operation.
Regulatory Compliance: Supports 21 CFR Part 11 compliance with secure data management and audit trails.
Applications in Biopharmaceutical Development
The MFI 5200 supports multiple critical stages of development and manufacturing:
Formulation optimization: Comparing formulations, excipients, or container/closure systems to minimize particle formation.
Process Monitoring: Assessing filtration efficiency, identifying contamination sources, and ensuring product stability throughout processing.
In-process Control and Batch Release: Supporting robust quality control with reliable sub-visible particle characterization aligned with regulatory requirements.
Agile Bioscience: Your Partner in Particle Analysis
Our experts understand the nuances of protein formulations. By choosing Agile Bioscience, you gain not only access to cutting-edge equipment but also deep knowledge to interpret the results effectively. We collaborate closely with our clients to tailor analytical solutions and deliver the actionable data you need.
Experience the MFI Difference
If sub-visible particle characterization is essential to your product quality and patient safety, look no further than Agile Bioscience. Discover how the MFI 5200 sets a new standard in accuracy, detail, and regulatory readiness. Contact us today to discuss your project needs.
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