Discrimination between silicone oil droplets and protein aggregates in biopharmaceuticals: A novel multiparametric image filter for sub-visible particles in microflow imaging analysis

Pharmaceutical Research

Volumn 29, Issue 2, 2012, Pages 594-602

  Strehl, René ^a   Rombach Riegraf, Verena ^a   Diez, Manuel ^a   Egodage, Kamal ^a   Bluemel, Markus ^a   Jeschke, Margit ^a   Koulov, Atanas V ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Biopharmaceuticals; Microflow imaging; Pre filled syringes; Protein aggregation; Silicone oil; Subvisible particles

Indexed keywords

SILICONE OIL; PROTEIN;

ANALYTICAL ERROR; ANALYTICAL PARAMETERS; ARTICLE; AUTOANALYSIS; COMPUTER PROGRAM; CONTROLLED STUDY; DRUG DISCRIMINATION; DRUG IDENTIFICATION; DRUG SYNTHESIS; EXPERIMENTAL TEST; FILTER; FREEZE THAWING; IMAGE ANALYSIS; IMAGING SYSTEM; MICROFLOW IMAGING ANALYSIS; MULTIPARAMETRIC IMAGE FILTER; PARTICLE SIZE; PRIORITY JOURNAL; PROTEIN AGGREGATION; RELIABILITY; SUSPENSION; IMAGE PROCESSING; METHODOLOGY; MICROSCOPY; ULTRASTRUCTURE;

IMAGE PROCESSING, COMPUTER-ASSISTED; MICROSCOPY; PROTEINS; SILICONE OILS;

EID: 84860855378     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0590-7     Document Type: Article

References (9)

1. Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J. 2006;8(3):E501-7.
2. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, et al. Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci. 2009;98(4):1201-5.
3. Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, et al. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci. 2010;99(8):3302-21.
4. Wuchner K, Büchler J, Spycher R, Dalmonte P, Volkin DB. Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation. J Pharm Sci. 2010;99(8):3343-61.
5. Liu L,Ammar DA, Ross LA, Mandava N,KahookMY, Carpenter JF. Silicone oil microdroplets and protein aggregates in repackaged bevacizumab and ranibizumab: effects of long-term storage and productmishandling. Invest Ophthalmol Vis Sci. 2011;52(2):1023-34.
6. Sharma DK, King D, Oma P, Merchant C. Micro-flow imaging: flow microscopy applied to sub-visible particulate analysis in protein formulations. AAPS J. 2010;12(3):455-64.
7. Sharma D, Oma P, Krishnan S. Silicone micro-droplets in protein formulations-detection and enumeration. Pharm Technol. 2009;33(4):74-9.
8. Mahler HC, Friess W, Grauschopf U, Kiese S. Protein aggregation: pathways, induction factors and analysis. J Pharm Sci. 2009;98(9):2909-34.
9. Huang CT, Sharma D, Oma P, Krishnamurthy R. Quantitation of protein particles in parenteral solutions using micro-flow imaging. J Pharm Sci. 2009;98(9):3058-71.