scholarly journals Collaborative Study for Analysis of Subvisible Particles Using Flow Imaging and Light Obscuration: Experiences in Japanese Biopharmaceutical Consortium

2019 ◽  
Vol 108 (2) ◽  
pp. 832-841 ◽  
Author(s):  
Masato Kiyoshi ◽  
Hiroko Shibata ◽  
Akira Harazono ◽  
Tetsuo Torisu ◽  
Takahiro Maruno ◽  
...  
Keyword(s):  
Collaborative Study ◽  
Flow Imaging ◽  
Subvisible Particles ◽  
Light Obscuration

Separation, Characterization and Discriminant Analysis of Subvisible Particles in Biologics Formulations

2019 ◽  
Vol 20 (3) ◽  
pp. 232-244 ◽  
Author(s):  
Zahir S. Akhunzada ◽  
Mario Hubert ◽  
Erinc Sahin ◽  
James Pratt
Keyword(s):  
Morphological Filter ◽  
Subvisible Particles ◽  
Light Obscuration ◽  
Protein Formulations ◽  
Limited Success ◽  
Intensity Parameters ◽  
Mixed Aggregates ◽  
Parenteral Formulations ◽  
Formulation Stability ◽  
Low Refractive Index

Background:The presence of subvisible particles (SVPs) in parenteral formulations of biologics is a major challenge in the development of therapeutic protein formulations. Distinction between proteinaceous and non-proteinaceous SVPs is vital in monitoring formulation stability.Methods:The current compendial method based on light obscuration (LO) has limitations in the analysis of translucent/low refractive index particles. A number of attempts have been made to develop an unambiguous method to characterize SVPs, albeit with limited success.Results:Herein, we describe a robust method that characterizes and distinguishes both potentially proteinaceous and non-proteinaceous SVPs in protein formulations using Microflow imaging (MFI) in conjunction with the MVAS software (MFI View Analysis Suite), developed by ProteinSimple. The method utilizes two Intensity parameters and a morphological filter that successfully distinguishes proteinaceous SVPs from non-proteinaceous SVPs and mixed aggregates.Conclusion:he MFI generated raw data of a protein sample is processed through Lumetics LINK software that applies an in-house developed filter to separate proteinaceous from the rest of the particulates.

Variance Between Different Light Obscuration and Flow Imaging Microscopy Instruments and the Impact of Instrument Calibration

2019 ◽  
Vol 108 (7) ◽  
pp. 2397-2405 ◽  
Author(s):  
Anja Matter ◽  
Atanas Koulov ◽  
Satish Singh ◽  
Hanns-Christian Mahler ◽  
Helena Reinisch ◽  
...  
Keyword(s):  
Flow Imaging ◽  
Instrument Calibration ◽  
Light Obscuration ◽  
The Impact

Measuring Subvisible Particles in Protein Formulations Using a Modified Light Obscuration Sensor with Improved Detection Capabilities

2015 ◽  
Vol 87 (12) ◽  
pp. 6119-6124 ◽  
Author(s):  
Anacelia Ríos Quiroz ◽  
Gabriela Québatte ◽  
Fabian Stump ◽  
Christof Finkler ◽  
Joerg Huwyler ◽  
...  
Keyword(s):  
Subvisible Particles ◽  
Light Obscuration ◽  
Protein Formulations ◽  
Detection Capabilities
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