Characterization of subvisible particle formation during the filling pump operation of a monoclonal antibody solution

Journal of Pharmaceutical Sciences

Volumn 100, Issue 10, 2011, Pages 4198-4204

  Nayak, Arpan ^a   Colandene, James ^a   Bradford, Victor ^a   Perkins, Melissa ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Filling; Formulation; Imaging methods; Particle size; Protein aggregation; Proteins

Indexed keywords

FILLER; IMMUNOGLOBULIN G1 ANTIBODY; MONOCLONAL ANTIBODY; IMMUNOGLOBULIN G; PROTEIN AGGREGATE;

ARTICLE; CONTROLLED STUDY; DRUG MANUFACTURE; DRUG QUALITY; FILLING PROCESS; FLOW MEASUREMENT; GEL PERMEATION CHROMATOGRAPHY; IMAGING; MICROFLOW IMAGING; PARTICLE SIZE; PARTICULATE MATTER; PERISTALTIC PUMP; PRESSURE; PROTEIN AGGREGATION; QUALITY CONTROL; SUBVISIBLE PARTICLE FORMATION; TURBIDIMETRY; TURBIDITY; CHEMISTRY; DEVICES; EQUIPMENT DESIGN; MEDICINAL CHEMISTRY; PHARMACEUTICS; PHOTOMETRY; PROCEDURES; SIZE EXCLUSION CHROMATOGRAPHY; WORKFLOW;

ANTIBODIES, MONOCLONAL; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GEL; EQUIPMENT DESIGN; IMMUNOGLOBULIN G; NEPHELOMETRY AND TURBIDIMETRY; PARTICLE SIZE; PROTEIN AGGREGATES; TECHNOLOGY, PHARMACEUTICAL; WORKFLOW;

EID: 80052265031     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22676     Document Type: Article

References (23)

1. Mahler H-C, Freiss W, Grauschopf U, Keise S. 2009. Protein aggregation: Pathways, induction factors and analysis. J Pharm Sci 98:2909-2934.
2. Kanai S, Liu J, Patapoff TW, Shire SJ. 2008. Reversible self-association of a concentrated monoclonal antibody solution mediated by Fab-Fab interaction that impacts solution viscosity. J Pharm Sci 97:4219-4227.
3. Randolph TW, Carpenter JF. 2007. Engineering challenges of protein formulations. AIChE J 53:1902-1907.
4. Rathore N, Rajan RS. 2008. Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol Prog 24:504-514.
5. Cromwell ME, Hilario E, Jacobson F. 2006. Protein aggregation and bioprocessing. AAPS J 8:E572-E579.
6. Tyagi AK, Randolph TW, Dong A, Maloney KM, Hitscherich Jr. C, Carpenter JF. 2009. IgG particle formation during filling pump operation: A case study of heterogeneous nucleation on stainless steel nanoparticles. J Pharm Sci 98:94-104.
7. Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D. 2009. A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol 10:373-381.
8. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G, Fan Y-X, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. 2009. Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality. J Pharm Sci 98:1201-1205.
9. Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, Cromwell M, Krause H-J, Mahler H-C, Meyer BK, Narhi L, Nesta DP, Spitznagel T. 2010. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci 99:3302-3321.
10. Singh SK. 2011. Impact of product-related factors on immunogenicity of biotherapeutics. J Pharm Sci 100:354-387.
11. The United States Pharmacopeia - The National Formulary. 2011. <788> Particulate matter in injections. USP 34 - NF 29. The United States Pharmacopeial Convention, Ed.
12. European Pharmacopoeia (7.0). 2011. 2.19.19 Particulate contamination: Sub-visible particles. European Directorate for the Quality of Medicines & HealthCare, Ed.
13. The United States Pharmacopeia - The National Formulary. 2011. <1> Injections. USP 34 - NF 29. The United States Pharmacopeial Convention, Ed.
14. European Pharmacopoeia (7.0). 2011. 2.19.20 Particulate contamination: Visible particles. European Directorate for the Quality of Medicines & HealthCare, Ed.
15. Sharma DK, Oma P, Pollo MJ, Sukumar M. 2010. Quantification and characterization of subvisible proteinaceous particles in opalescent mAb formulations using Micro-Flow Imaging. J Pharm Sci 99:2628-2642.
16. Wuchner K, Buchler J, Spycher R, Dalmonte P, Volkin DB. 2010. Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation. J Pharm Sci 99:3343-3361.
17. Huang C-T, Sharma D, Oma P, Krishnamurthy R. 2009. Quantitation of protein particles in parenteral solutions using Micro-Flow Imaging. J Pharm Sci 98:3058-3071.
18. Kiese S, Pappenberger A, Friess W, Mahler H-C. 2010. Equilibrium studies of protein aggregates and homogeneous nucleation in protein formulation. J Pharm Sci 99:632-644.
19. Maa Y-F, Hsu CC. 1996. Effect of high shear on proteins. Biotechnol Bioeng 51:458-465.
20. Maa Y-F, Hsu CC. 1997. Protein denaturation by combined effect of shear and air-liquid interface. Biotechnol Bioeng 54:503-512.
21. Thomas CR, Geer D. 2011. Effects of shear on proteins in solution. Biotechnol Lett 33:443-456.
22. Barnard JG, Singh S, Randolph TW, Carpenter JF. 2011. Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: Insights into the roles of particles in the protein aggregation pathway. J Pharm Sci 100:492-503.
23. Peterson A. 2009. Filling methods as they apply to parenteral product quality and biopharmaceutical microdosing. In Practical aseptic processing: Fill and finish; Lysfjord J, Ed. 1st ed. Bethesda, Maryland/River Grove, Illinois: PDA/DHI Publishing, pp 145-165.