Quantification and characterization of subvisible proteinaceous particles in opalescent mab formulations using micro-flow imaging

Journal of Pharmaceutical Sciences

Volumn 99, Issue 6, 2010, Pages 2628-2642

  Sharma, K Deepak ^a   Peter, Oma ^a   Pollo, Mark J ^b   Sukumar, Muppalla ^b  

^a Brightwell Technologies Inc   (Canada)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

Image analysis; Particle size; Physical stability; Preformulation; Protein formulation

Indexed keywords

GLASS; MONOCLONAL ANTIBODY; POLYSTYRENE;

ARTICLE; CHEMICAL MODEL; COLOR; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG FORMULATION; IMAGE ANALYSIS; IMAGING; MICRO FLOW IMAGING; OPALESCENCE; PARTICLE SIZE; PROTEIN DENATURATION;

EID: 77951552352     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22046     Document Type: Article

References (28)

1. Cleland JL, Powell MF, Shire SJ. 1993. The development of stable protein formulations: A close look at protein aggregation, deamidation, and oxidation. Crit Rev Ther Drug Carrier Syst 10:307-377. Review. Erratum in: Crit Rev Ther Drug Carrier Syst 1994;11:60.
2. Chi EY, Krishnan S, Randolph TW, Carpenter JF. 2003. Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation. Pharm Res 20: 1325-1336. (Pubitemid 37164039)
3. Kamerzell TJ, Middaugh CR. 2008. The complex inter-relationships between protein flexibility and stability. J Pharm Sci 97: 3494-3517.
4. Wang W. 1999. Instability, stabilization, and formulation of liquid protein pharmaceuticals. Int J Pharm 185:129-188. (Pubitemid 29392904)
5. Cromwell MEM, Hilario E, Jacobson F. 2006. Protein aggregation and bioprocessing. AAPS J 8:E572-E579.
6. Philo JS. 2006. Is any measurement method optimal for all aggregate sizes and types? AAPS J 8:E564-E571. Review.
7. Liu J, Andya JD, Shire SJ. 2006. A critical review of analytical ultracentrifugation and field flow fractionation methods for measuring protein aggregation. AAPS J 8:E580-E589. (Pubitemid 44507669)
8. Mahler HC, Müller R, Friess W, Delille A, Matheus S. 2005. Induction and analysis of aggregates in a liquid IgG1-antibody formulation. Eur J Pharm Biopharm 59:407-417.
9. US Pharmacopeia. 2007. USP/NF General Chapeter 〈788〉. Particulate matter in injections. In: US Pharmacopeia, National Formulary, USP31-NF-26. Rockville, MD: USP.
10. European Pharmacopoeia, 5th edn. Main volume5.0 (incl. suppl 5.1). General Chapter 2.9.20. Particulate contamination: Visible particles. European Pharmacopoeia Commission, Council of Europe, European Department for the Quality of Medicines, 2005.
11. Garvan JM, Gunner BW. 1964. The harmful effects of particles in intravenous fluids. Med J Aust 4:1-6.
12. Rosenberg AS. 2006. Effects of protein aggregates: An immunologic perspective. AAPS J 8:E501-E507.
13. Japanese Pharmacopoeia, 14th edn. General Chapter 20. Foreign insoluble particulate matter test for injections. Society of Japanese Pharmacopoeia, 2006.
14. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, 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.
15. Barber TA, Lannis MD, Williams JG. 1989. Method evaluation: Automated microscopy as a compendial test for particulates in parenteral solutions. J Parenter Sci Technol 43:27-47.
16. Barber TA, Lannis MD, Williams JG, Ryan JF. 1990. Application of improved standardization methods and instrumentation in the USP particulate test for SVI. J Parenter Sci Technol 44:185-203.
17. Barber TA, Borchert SJ, Carleton FJ, Knapp JZ. 1987. Overview of the International Conference on Liquid Borne Particle Inspection and Metrology. J Parenter Sci Technol 41:193-197. Erratum in: J Parenter Sci Technol 1988;42:256.
18. Tricome JR, Lannis MD, Sax RJ. 1986. A comparison of the HIAC particle size analyzer, an automated image analyzer and the PMA membrane microscopic method of particle size analysis. J Parenter Sci Technol 40:58-60.
19. Huang CT, Sharma D, Oma P, Krishnamurthy R. 2008. Quantitation of protein particles in parenteral solutions using micro-flow imaging. J Pharm Sci 98:3058-3071.
20. Sharma DK, King D, Moore P, Oma P, Thomas D. 2007. Flow microscopy for particulate analysis in parenteral and pharmaceutical fluids. Eur J Parent Pharm Sci 12:97-101.
21. Shire SJ, Shahrokh Z, Liu J. 2004. Challenges in the development of high protein concentration formulations. J Pharm Sci 93:1390-1402.
22. Sukumar M, Doyle BL, Combs JL, Pekar AH. 2004. Opalescent appearance of an IgG1 antibody at high concentrations and its relationship to noncovalent association. Pharm Res 21:1087-1093.
23. Salinas BA, Sathish HA, Bishop SM, Harn N, Carpenter JF, Randolph TW. 2010. Understanding and modulating opalescence and viscosity in a monoclonal antibody formulation. J Pharm Sci 99:82-93.
24. Li B, Flores J, Corvari V. 2007. A simple method for the detection of insoluble aggregates in protein formulations. J Pharm Sci 96:1840-1843.
25. Vörös J. 2004. The density and refractive index of adsorbing protein layers. Biophys J 87:553-561.
26. Hawe A, Friess W. 2007. Stabilization of a hydrophobic recombinant cytokine by human serum albumin. J Pharm Sci 96:2987-2999.
27. Demeule B, Gurny R, Arvinte T. 2007. Detection and characterization of protein aggregates by fluorescence microscopy. Int J Pharm 329:37-45.
28. Tyagi AK, Randolph TW, Dong A, Maloney KM, Hitscherich C, Jr., 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.