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Micro-particle Image Velocimetry for Velocity Profile Measurements of Micro Blood Flows
Published on: April 25, 2013
Quantitation of protein particles in parenteral solutions using micro-flow imaging
Chi-Ting Huang1, Deepak Sharma, Peter Oma
1Acceleron Pharma, 149 Sidney Street, Cambridge, Massachusetts 02139, USA.
Journal of Pharmaceutical Sciences
|October 22, 2008
Summary
Micro-Flow Imaging (MFI) detects more protein particulates than light obscuration, offering a more sensitive method for therapeutic drug safety testing. This advanced particle analysis aids in developing better drug formulations.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
- Biotechnology
Background:
- Pharmacopeias mandate particulate testing for therapeutic safety and clinical suitability.
- Subvisible and visible particles require accurate sizing and counting.
- Light obscuration is the current standard for subvisible particulate matter measurement.
Purpose of the Study:
- To compare the sizing and counting accuracy of light obscuration and Micro-Flow Imaging (MFI).
- To evaluate the detection capabilities of MFI for protein particulates in therapeutics.
Main Methods:
- An immunoconjugate was used as a model protein to induce particulate formation.
- Light obscuration was performed according to USP chapter <788>.
- Micro-Flow Imaging (MFI) measurements followed manufacturer's procedures.
Main Results:
- Both techniques showed similar results for polystyrene standards.
- MFI detected significantly more particles in the protein solution than light obscuration.
- MFI identified nonspherical particles and those with similar refractive indices to the solvent, missed by light obscuration.
Conclusions:
- MFI offers superior detection of protein particulates compared to light obscuration.
- Imaging-based technologies like MFI can improve the development of formulations and processes to minimize protein particulate formation.
- Accurate particulate analysis is crucial for ensuring therapeutic safety and efficacy.
