Reference material development for calibration and verification of image-based particle analyzers

International Journal of Pharmaceutics

Volumn 416, Issue 1, 2011, Pages 293-295

  Sharma, Deepak K ^a   King, David ^a   Merchant, Clark ^a  

^a Brightwell Technologies Inc   (Canada)

Author keywords

Image analysis; Micro Flow Imaging; Particle counting; Particle sizing; Protein aggregation; Sub visible particles

Indexed keywords

NANOPARTICLE; POLYSTYRENE; PROTEIN; SILICON DIOXIDE;

ANALYZER; ARTICLE; CALIBRATION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG STABILITY; IMAGE BASED PARTICLE ANALYZER; MICRO FLOW IMAGING; PARTICLE SIZE; PRIORITY JOURNAL; PROTEIN AGGREGATION; SENSITIVITY REFERENCE SUSPENSION;

CALIBRATION; CHEMISTRY TECHNIQUES, ANALYTICAL; MICROSCOPY; PARTICLE SIZE; PROTEINS; REFERENCE STANDARDS; REFRACTOMETRY; SILICON DIOXIDE; SUSPENSIONS;

EID: 80051786496     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.05.078     Document Type: Article

References (7)

1. J. Carpenter, T.W. Randolph, W. Jiskoot, D. Crommelin, C. Middaugh, G. Winter, Y. Fan, S. Kirshner, D. Verthelyi, S. Kozlowski, K. Clouse, P. Swann, A. Rosenberg, and B. Cherney Overlooking sub-visible particles in therapeutic protein products: gaps that may compromise product quality J. Pharm. Sci. 98 2009 1201 1205
2. C. Huang, D. Sharma, P. Oma, and R. Krishnamurthy Quantitation of protein particles in parenteral solutions using Micro-Flow Imaging J. Pharm. Sci. 98 2009 3058 3071
3. Ripple, D.; 2010. NIST perspective on standards and GMP processes for subvisible particles in protein therapeutics. IBC Formulation Strategies for Protein Therapeutics, September 21, 2010, Rhode Island, Providence, USA.
4. D. Sharma, D. King, P. Moore, P. Oma, and D. Thomas Flow microscopy for particulate analysis in parenteral and pharmaceutical fluids Eur. J. Parent. Pharm. Sci. 12 2007 97 101
5. D. Sharma, D. King, C. Merchant, and P. Oma Micro-Flow Imaging: flow microscopy applied to sub-visible particulate analysis in protein formulations AAPS J. 2010 10.1208/s12248-010-9205-1
6. D. Sharma, P. Oma, M.J. Pollo, and M. Sukumar Quantification and characterization of subvisible proteinaceous particles in opalescent mAb formulations using Micro-Flow Imaging J. Pharm. Sci. 99 2010 2628 2642
7. K. Wuchner, J. Buchler, R. Spycher, P. Dlamonte, and D.B. Volken Development of a micro-flow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation J. Pharm. Sci. 99 2010 3343 3361