Particles shed from syringe filters and their effects on agitation-induced protein aggregation

Journal of Pharmaceutical Sciences

Volumn 101, Issue 8, 2012, Pages 2952-2959

  Liu, Lu ^a   Randolph, Theodore W ^b   Carpenter, John F ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b University of Colorado   (United States)

Author keywords

Agitation; Filter; Heterogeneous nucleation; Light scattering (dynamic); Micro flow imaging; Particle sizing; Protein aggregation; Stability; UV VIS spectroscopy

Indexed keywords

BORON DERIVATIVE; FIBROBLAST GROWTH FACTOR 10; GLASS; SILICATE;

ADSORPTION; ARTICLE; FILTER; FILTRATION; IMAGING SYSTEM; LIGHT SCATTERING; MATERIALS; MEMBRANE FILTER; MICRO FLOW IMAGING; PARTICLE SIZE; PROTEIN AGGREGATION; SYRINGE; ULTRAVIOLET SPECTROSCOPY;

EID: 84862872600     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23225     Document Type: Article

References (44)

1. Buchta C, Dettke M, Funovics PT, Hirschl AM, Macher M, Worel N, Hocker P. 2004. Impact of manufacturing, irradiation and filtration steps to bacterial contamination of autologous fibrin sealant. Biologicals 32(3):165-169.
2. Gupta PK, Porembski E, Williams NA. 1994. Approaches to reducing subvisible particle counts in lyophilized parenteral formulations. J Pharm Sci Technol 48(1):30-37.
3. Hirakawa M, Makino K, Nakashima K, Kataoka Y, Oishi R. 1999. Evaluation of the in-line filters for the intravenous infusion of amphotericin B fluid. J Clin Pharm Ther 24(5):387-392.
4. Sendo T, Hirakawa M, Makino K, Nakashima K, Kataoka Y, Oishi R. 2001. Particulate contamination of lyophilized amphotericin B preparation during reconstitution process. J Clin Pharm Ther 26(2):87-91.
5. Kuramoto K, Shoji T, Nakagawa Y. 2006. Usefulness of the final filter of the IV infusion set in intravenous administration of drugs-Contamination of injection preparations by insoluble microparticles and its causes. Yakugaku Zasshi 126(4):289-295.
6. Madsen H, Winding O. 1996. Release of foreign bodies (particles) by clinical use of intravenous infusion sets. Biomaterials 17(7):663-666.
7. Subramanian P, Ainsworth P, Cassey J, Phelan D. 2002. Lost bits: Particle shedding with polyvinyl chloride intravenous administration sets. Pediatr Surg Int 18(8):658-661.
8. Barron D, Harbottle S, Hoenich NA, Morley AR, Appleton D, McCabe JF. 1986. Particle spallation induced by blood pumps in hemodialysis tubing sets. Artif Organs 10(3):226-235.
9. Stenvinkel P. Chronic kidney disease: A public health priority and harbinger of premature cardiovascular disease. J Intern Med 268(5):456-467.
10. Coca SG, Yusuf B, Shlipak MG, Garg AX, Parikh CR. 2009. Long-term risk of mortality and other adverse outcomes after acute kidney injury: A systematic review and meta-analysis. Am J Kidney Dis 53(6):961-973.
11. Andya JD, Maa YF, Costantino HR, Nguyen PA, Dasovich N, Sweeney TD, Hsu CC, Shire SJ. 1999. The effect of formulation excipients on protein stability and aerosol performance of spray-dried powders of a recombinant humanized anti-IgE monoclonal antibody. Pharm Res 16(3):350-358.
12. 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(2):256-274.
13. Lin JJ, Meyer JD, Carpenter JF, Manning MC. 2000. Stability of human serum albumin during bioprocessing: Denaturation and aggregation during processing of albumin paste. Pharm Res 17(4):391-396.
14. Maa YF, Hsu CC. 1996. Membrane fouling in sterile filtration of recombinant human growth hormone. Biotechnol Bioeng 50(3):319-328.
15. Maa YF, Hsu CC. 1998. Investigation on fouling mechanisms for recombinant human growth hormone sterile filtration. J Pharm Sci 87(7):808-812.
16. Mahler HC, Huber F, Kishore RS, Reindl J, Ruckert P, Muller R. Adsorption behavior of a surfactant and a monoclonal antibody to sterilizing-grade filters. J Pharm Sci 99(6):2620-2627.
17. Mumenthaler M, Hsu CC, Pearlman R. 1994. Feasibility study on spray-drying protein pharmaceuticals: Recombinant human growth hormone and tissue-type plasminogen activator. Pharm Res 11(1):12-20.
18. Berting A, Goerner W, Spruth M, Kistner O, Kreil TR. 2005. Effective poxvirus removal by sterile filtration during manufacture of plasma derivatives. J Med Virol 75(4):603-607.
19. Rozkov A, Larsson B, Gillstrom S, Bjornestedt R, Schmidt SR. 2008. Large-scale production of endotoxin-free plasmids for transient expression in mammalian cell culture. Biotechnol Bioeng 99(3):557-566.
20. van Reis R, Zydney A. 2001. Membrane separations in biotechnology. Curr Opin Biotechnol 12(2):208-211.
21. Liu SJ, Carroll M, Iverson R, Valera C, Vennari J, Turco K, Piper R, Kiss R, Lutz H. 2000. Development and qualification of a novel virus removal filter for cell culture applications. Biotechnol Prog 16(3):425-434.
22. van Reis R, Zydney A. 2007. Bioprocess membrane technology. J Membr Sci 297(1-2):16-50.
23. Zydney AL. 2009. Membrane technology for purification of therapeutic proteins. Biotechnol Bioeng 103(2):227-230.
24. Ortolano GA, Russell RL, Angelbeck JA, Schaffer J, Wenz B 2004. Contamination control in nursing with filtration. Part 1: Filters applied to intravenous fluids and point-of-use hospital water. J Infus Nurs 27(2):89-103.
25. Yamashita AC, Tomisawa N. Membrane materials for blood purification in critical care. Contrib Nephrol 166:112-118.
26. Ulbricht M. 2006. Advanced functional polymer membranes. Polymer 47(7):2217-2262.
27. Pearce G. 2007. Introduction to membranes: Membrane selection. Filtration Sep 44(3):35-37.
28. Pincet F, Perez E, Belfort G. 1995. Molecular interactions between proteins and synthetic membrane polymer films. Langmuir 11(4):1229-1235.
29. Sethuraman A, Han M, Kane RS, Belfort G. 2004. Effect of surface wettability on the adhesion of proteins. Langmuir 20(18):7779-7788.
30. Sethuraman A, Vedantham G, Imoto T, Przybycien T, Belfort G. 2004. Protein unfolding at interfaces: Slow dynamics of alpha-helix to beta-sheet transition. Proteins 56(4):669-678.
31. Bee JS, Chiu D, Sawicki S, Stevenson JL, Chatterjee K, Freund E, Carpenter JF, Randolph TW. 2009. Monoclonal antibody interactions with micro- and nanoparticles: Adsorption, aggregation, and accelerated stress studies. J Pharm Sci 98(9):3218-3238.
32. Ludwig DB, Carpenter JF, Hamel JB, Randolph TW. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J Pharm Sci 99(4):1721-1733.
33. Thirumangalathu R, Krishnan S, Ricci MS, Brems DN, Randolph TW, Carpenter JF. 2009. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J Pharm Sci 98(9):3167-3181.
34. Bee JS, Davis M, Freund E, Carpenter JF, Randolph TW 2010. Aggregation of a monoclonal antibody induced by adsorption to stainless steel. Biotechnol Bioeng 105(1):121-129.
35. Liu W, Swift R, Torraca G, Nashed-Samuel Y, Wen ZQ, Jiang Y, Vance A, Mire-Sluis A, Freund E, Davis J, Narhi L. 2010. Root cause analysis of tungsten-induced protein aggregation in pre-filled syringes. PDA J Pharm Sci Technol 64(1):11-19.
36. Cabaleiro-Lago C, Quinlan-Pluck F, Lynch I, Dawson KA, Linse S. 2010. Dual effect of amino modified polystyrene nanoparticles on amyloid beta protein fibrillation. ACS Chem Neurosci 1(4):279-287.
37. 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(1):94-104.
38. Cheang BL, Zydney AL. 2004. A two-stage ultrafiltration process for fractionation of whey protein isolate. J Membr Sci 231(1-2):159-167.
39. Lomakin A, Chung DS, Benedek GB, Kirschner DA, Teplow DB. 1996. On the nucleation and growth of amyloid beta-protein fibrils: Detection of nuclei and quantitation of rate constants. Proc Natl Acad Sci U S A 93(3):1125-1129.
40. Harper JD, Lansbury PT, Jr. 1997. Models of amyloid seeding in Alzheimer's disease and scrapie: Mechanistic truths and physiological consequences of the time-dependent solubility of amyloid proteins. Annu Rev Biochem 66:385-407.
41. Linse S, Cabaleiro-Lago C, Xue WF, Lynch I, Lindman S, Thulin E, Radford SE, Dawson KA. 2007. Nucleation of protein fibrillation by nanoparticles. Proc Natl Acad Sci U S A 104(21):8691-8696.
42. Lee CC, Nayak A, Sethuraman A, Belfort G, McRae GJ. 2007. A three-stage kinetic model of amyloid fibrillation. Biophys J 92(10):3448-3458.
43. Uji Y, Motomiya Y, Ando Y. 2009. A circulating beta 2-microglobulin intermediate in hemodialysis patients. Nephron Clin Pract 111(3):c173-181.
44. Pavone B, Sirolli V, Bucci S, Libardi F, Felaco P, Amoroso L, Sacchetta P, Urbani A, Bonomini M. 2010. Adsorption and carbonylation of plasma proteins by dialyser membrane material: In vitro and in vivo proteomics investigations. Blood Transfus 8(Suppl 3):s113-s119.