| [FlowCAM] 비경구 약배합과정에서의 단백질 응집 검출 | |
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| 작성자 : 삼보과학 작성일 : 2011-04-28 조회수 : 4508 | |
| 파일첨부 : Protein_Aggegates_App_Note_200ppi[1].pdf | |
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Detection of Protein Aggregates in Parenteral Drug
Formulations ============================================================= Objective Aggregation of proteins in parenteral drugs is a serious issue, and must be closely monitored to meet FDA regulations. Of particular importance is consistent reporting of particles larger than 10μm and particles larger than 25μm found in the formulation. These particles can be both protein aggregates and “other” particles, such as silicone oil droplets or air bubbles. While microscopy can be used for this type of analysis, the concentration of these particles is typically so low that it is time prohibitive to analyze using a microscope. As a result, formulators and QC personnel have typically turned to automated particle sizing methods such as light obscuration, electrozone sensing and laser diffraction. The problem with these techniques is that they use measurement techniques that assume all particles are spherical in shape, recording only an Equivalent Spherical Diameter (ESD) for each particle. This can lead to costly miscounts when “other, allowable” particles such as silicone droplets get counted. Inevitably, this could lead to the premature disposal of a batch due to it being “out of spec”. Light obscuration has the further issue of not being able to detect transparent particles. <전문을 보시기를 원하시는 분은 첨부화일을 다운로드하여 보시기 바랍니다.> |
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| 이전글 | [FlowCAM] 입자 이미지 분석 : 분해능 및 샘플링 고찰 |
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| 다음글 | [FlowCAM] FlowCAM을 이용한 Microencapsulation 과정 분석 |
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고객지원 > 종합자료실
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