Quantitation of protein particles in parenteral solutions using micro-flow imaging

Journal of Pharmaceutical Sciences

Volumn 98, Issue 9, 2009, Pages 3058-3071

  Huang, Chi Ting ^a   Sharma, Deepak ^b   Oma, Peter ^b   Krishnamurthy, Rajesh ^c  

^a Acceleron Pharma   (United States)

^b Brightwell Technologies Inc   (Canada)

^c IMMUNOGEN INC   (United States)

Author keywords

Analytical chemistry; Excipients; Image analysis; Imaging methods; Injectables; Light scattering; Particle size; Protein aggregation; Protein formulation; Proteins

Indexed keywords

ANTIBODY CONJUGATE; PARENTERAL SOLUTION; POLYSTYRENE;

ARTICLE; CONTROLLED STUDY; DRUG FORMULATION; IMAGING SYSTEM; PARTICULATE MATTER; PROTEIN ANALYSIS; QUANTITATIVE ANALYSIS;

EID: 68949132582     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21575     Document Type: Article

References (45)

1. 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)
2. Chi EY, Weickmann J, Carpenter JF, Manning MC, Randolph TW. 2005. Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation. J Pharm Sci 94:256-274. (Pubitemid 40293323)
3. Hsu CC, Nguyen HM, Yeung DA, Brooks DA, Koe GS, Bewley TA, Pearlman R. 1995. Surface denaturation at solid-void interface - A possible pathway by which opalescent particulates form during the storage of lyophilized tissue-type plasminogen activator at high temperatures. Pharm Res 12:69-77.
4. Pikal MJ, Dellerman KM, Roy ML, Riggin RM. 1991. The effects of formulation variables on the stability of freeze-dried human growth hormone. Pharm Res 8:427-436.
5. Sluzky V, Tamada JA, Klibanov AM, Langer R. 1991. Kinetics of insulin aggregation in aqueous solutions upon agitation in the presence of hydrophobic surfaces. Proc Natl Acad Sci USA 88:9377-9381. (Pubitemid 21915634)
6. Rubino JT, Chan LL, Walker JT, Segretario J, Everlof JG, Hussain MA. 1999. Photoinduced particulate matter in a parenteral formulation for bisnafide, an experimental antitumor agent. Pharm Dev Technol 4:439-447. (Pubitemid 29352903)
7. Mahler HC, Muller 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. (Pubitemid 40342515)
8. Zweifach BW. 1955. Structural makeup of capillary wall. Ann NY Acad Sci 61:670-677.
9. Lehr HA, Brunner J, Rangoonwala R, Kirkpatrick CJ. 2002. Particulate matter contamination of intravenous antibiotics aggravates loss of functional capillary density in postischemic striated muscle. Am J Respir Crit Care Med 165:514-520. (Pubitemid 34165475)
10. James DE, Jenkins AB, Kraegen EW, Chisholm DJ. 1981. Insulin precipitation in artificial infusion devices. Diabetologia 21:554-557. (Pubitemid 12242272)
11. Brange J, Havelund S. 1983. Insulin pumps and insulin quality - Requirements and problems. Acta Med Scand Suppl 671:135-138.
12. Denis J, Majeau N, Acosta-Ramirez E, Savard C, Bedard MC, Simard S, Lecours K, Bolduc M, Pare C, Willems B, Shoukry N, Tessier P, Lacasse P, Lamarre A, Lapointe R, Lopez Macias C, Leclerc D. 2007. Immunogenicity of papaya mosaic virus-like particles fused to a hepatitis C virus epitope: Evidence for the critical function of multimerization. Virology 363:59-68. (Pubitemid 46695744)
13. Rosenberg AS. 2006. Effects of protein aggregates: An immunologic perspective. AAPS J 8:E501-E507.
14. U. S. Pharmacopeia. 2006. 〈788〉 Particulate Matter in Injections. The United States Pharmacopeia - National Formulary, USP 29-NF, 24 ed.: U. S. Pharmacopeia.
15. The European Directorate for the Quality of Medicines & Healthcare. 2008. 2.19.19 Particulate contamination: Sub-visible particles. The European Pharmacopeia, 6.1 ed.: The European Directorate for the Quality of Medicines & Healthcare.
16. U.S. Pharmacopeia. 2006. 〈1〉 Injections. The United States Pharmacopeia - National Formulary, USP 29-NF, 24 ed.: U.S. Pharmacopeia.
17. The European Directorate for the Quality of Medicines & Healthcare. 2008. 2.19.20 Particulate contamination: Visible particles. The European Pharmacopeia, 6.1 ed.: The European Directorate for the Quality of Medicines & Healthcare.
18. Wang W. 2005. Protein aggregation and its inhibition in biopharmaceutics. Int J Pharm 289:1-30. (Pubitemid 40093537)
19. 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.
20. 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.
21. Fujishita O, Sendo T, Hisazumi A, Otsubo K, Aoyama T, Oishi R. 1995. The evaluation of sizing accuracy of particle counters for parenteral drugs. PDA J Pharm Sci Technol 49:267-271. (Pubitemid 26006277)
22. Knapp JZ, Kushner HK. 1980. Implementation and automation of a particle detection system for parenteral products. J Parenter Drug Assoc 34:369-393.
23. Knapp JZ, Kushner HK, Abramson LR. 1981. Automated particulate detection for ampuls with use of the probabilistic particulate detection model. J Parenter Sci Technol 35:21-35.
24. Schipper D, Gaines R. 1978. Comparison of optical electronic inspection and manual visual inspection. J Parenter Drug Assoc 32:118-126. (Pubitemid 8384401)
25. Hohmann RC, Conca N, Munnelly KP. 1973. Image projection for quantitating particulates in parenteral products. Bull Parenter Drug Assoc 27:96-100.
26. Levy JD, McCarthy CJ, Stevens RE. 1977. Application of image analysis for the rapid determination of particles in parenteral solutions. Bull Parenter Drug Assoc 31:299-301.
27. 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.
28. Lambert J. 2005. Drug-conjugated monoclonal antibodies for the treatment of cancer. Curr Opin Pharmacol 5:543-549. (Pubitemid 41258574)
29. http://www.immunogen.com/wt/page/IMGN901b. Accessed on July 20, 2008.
30. Chanan-Khan A, Jagannath S, Schlossman R, Fram RJ, Falzone RM, Ruberti MF, Welch SK, DePaolo D, Anderson K, Munshi N. American Society of Hematology, 49th Annual Meeting and Exposition. Orlando, Florida, 2006.
31. Ernerot L, Sandell E. 1967. Membrane filtration during administration of infusion fluids for elimination of particulate matter. Acta Pharm Suec 4:293-296.
32. Turco SJ, Davis NM. 1973. Comparison of final filtration devices. Bull Parenter Drug Assoc 27:207-227.
33. Groves MJ. 1991. Particulate contamination in parenterals: Current issues. Boll Chim Farm 130:347-354.
34. Barber TA. 1999. Control of particulate matter in healthcare manufacturing. 1st edition. Boca Raton, FL: CRC Press.
35. Van der Veen J, Verbrugge P, Van de Vaart FJ, Boom FA. 1997. Particulate matter determination in LVPs produced in Dutch hospital pharmacies, Part 1: Particle-counting accuracy. PDA J Pharm Sci Technol 51:81-88. (Pubitemid 27198173)
36. Zhang X, Kirsch LE. 2003. An assessment of techniques for evaluating the physical stability of parenteral emulsions. PDA J Pharm Sci Technol 57:300-315. (Pubitemid 37140054)
37. Garvan JM, Gunner BW. 1964. The harmful effects of particles in intravenous fluids. Med J Aust 2:1-6.
38. Garvan JM, Gunner BW. 1963. Intravenous fluids: "a solution containing particles must not be used". Med J Aust 50:140-145.
39. Berkowitz SA. 2006. Role of analytical ultracentrifugation in assessing the aggregation of protein biopharmaceuticals. AAPS J 8:E590-E605.
40. Krishnamurthy R, Sukumar M, Das TK, Lacher NA. 2008. Emerging analytical technologies for the pharmaceutical development of biotherapeutics. BioProcess Int 6:32-42.
41. Liu J, Nguyen MD, Andya JD, Shire SJ. 2005. Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution. J Pharm Sci 94:1928-1940. (Pubitemid 41551477)
42. 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. (Pubitemid 38954191)
43. 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. (Pubitemid 47122960)
44. Demeule B, Gurny R, Arvinte T. 2007. Detection and characterization of protein aggregates by fluorescence microscopy. Int J Pharm 329:37-45. (Pubitemid 44937520)
45. Doub WH, Adams WP, Spencer JA, Buhse LF, Nelson MP, Treado PJ. 2007. Raman chemical imaging for ingredient-specific particle size characterization of aqueous suspension nasal spray formulations: A progress report. Pharm Res 24:934-945.