Monocyte activation test better able to detect non-endotoxin...

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

Reexamination Certificate

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C435S007210, C435S287200

Reexamination Certificate

active

08053200

ABSTRACT:
An improved monocyte activation test is described that is better able to detect non-endotoxin pyrogens in medical products, in which a sample is incubated with a monocyte-containing reagent in an assay system comprising at least one surface comprising polypropylene. The invention also concerns assay systems for use in these tests that include at least one microtiter well having at least one interior surface comprising polypropylene and having a shape such that monocyte-containing reagent is concentrated in the well to provide greater cell to cell contact. The invention also relates to a diagnostic kit that can be used to test for the presence of non-endotoxin pyrogens in a sample.

REFERENCES:
patent: 4434237 (1984-02-01), Dinarello
patent: 5128270 (1992-07-01), Delacroix et al.
patent: 5281540 (1994-01-01), Merkh et al.
patent: 5891728 (1999-04-01), Wendel et al.
patent: 6696261 (2004-02-01), Patel et al.
patent: 7736863 (2010-06-01), Poole et al.
patent: 2001/0034037 (2001-10-01), Patel et al.
patent: 1994-317590 (1994-11-01), None
patent: WO 93/02361 (1993-02-01), None
patent: WO 94/10571 (1994-05-01), None
Poole et al., (J Immunol Meth. Mar. 1, 2003;274(1-2):209-220.
Poole et al., (J Immunol Meth. Mar. 1, 2003;274(1-2):209-220).
web.archive.org/web/2003101901343
uncbrand.com/page.asp?ID=298&lang=GB (NuncBrand FAQ for Immunology Products, published on the Internet at least since Jan. 2, 2004).
Carlin et al., In vitro pyrogenicity of a multivalent vaccine.Infanrix,Pharmeuropa, 15(3): 418-23 (2003).
Charles River Laboratories, Endosafe Times, 2(1): 1-6 (Sep. 2004).
DeLay Ed.Cytokine Protocols, Humana Press, Totowa, NJ., pp. 47 and 207 (2004).
Desch et al., Production of human tumor necrosis factor from whole blood ex vivo,Lymphokine Res. 8(2):141-6 (1989).
Dinarello et al., Human leukocytic pyrogen test for detection of pyrogenic material in growth hormone produced by recombinantEscherichia coli, J. Clin. Microbiol. 20(3):323-9 (1984).
Duff et al., The detection of endotoxin by in vitro production of endogenous pyrogen: Comparison withLimulus amebocytelysate gelation.J. Immunol. Meth. 52:323-31 (1982).
Eperon et al., Human monocytoid cell lines as indicators of endotoxin: comparison with rabbit pyrogen andLimulus amoebocytelysate assay.J. Immunol. Meth. 207:135-45 (1997).
Eperon et al., The use of human monocytoid lines as indicators of endotoxin.J. Immunol. Meth. 194:121-9 (1996).
Fennrich et al., Detection of endotoxins and other pyrogens using human whole blood,Dev. Biol Stand., 101:131-9 (1999).
Fennrich et al., New applications of the human whole blood pyrogen assay (PyroCheck), ALTEX, 16:146-9 (1999).
Finch-Arietta et al., Cytokine production in whole blood ex vivo,Agents Actions, 34: ½ (1991).
Fujiwara et al., Measurement of endotoxin in blood products using an endotoxin-specific Limulus test reagent and its relation to pyrogenic activities in rabbit,Yakugaku Zasshi, 110 (5):332-40 (1990).
Gaines Das et al., Monocyte activation test for pro-inflammatory and pyrogenic contaminants of parenteral drugs: test design and data analysis, 288 (1-2): 165-177. (2004).
Gaines-Das et al., Monocyte activation test for pro-inflammatory and pyrogenic contaminants of parenteral drugs: test design and data analysis.J. Immunol. Meth. 288(1-2):165-77 (2004).
Hansen et al., Comparison of cultured human mononuclear cells,Limulus amebocytelysate and rabbits in the detection of pyrogens,J. Clin. Pharm. Thera. 15: 425-33 (1990).
Hartung et al., Detection of pyrogens using human whole blood,In Vitro Toxicology, 9(4): 353-9 (1996).
Hartung et al., Novel pyrogen tests based on the human fever reaction,Altern Lab Anim. 29:99-123 (2001).
Hoffmann et al., International validation of novel pyrogen tests based on human monocytoid cells,J. Immunol. Meth. 298:161-73 (2005).
web.archive.org/web/2003101901343
uncbrand.com/page.asp?ID=298&lang=GB (NuncBrand FAQ for Immunology Products, published on the Internet at least since Jan. 2, 2004) (hereinafter “NuncBrand.com archive”), 7 pages.
Jahnke et al., Comparative testing for pyrogens in parenteral drugs using the human whole blood pyrogen test, the rabbit in vivo pyrogen test and the LAL test,Eur. J. Parent. Sci., 5(2):39-44 (2000).
Martis et al., Aseptic peritonitis due to peptidoglycan contamination of pharmacopoeia standard dialysis solution,Lancet, 365: 588-94 (2005).
Mascoli et al., Applications and advantages of theLimulus amebocytelysate (LAL) pyrogen test for parenteral injectable products,Prog. Clin. Biol. Res., 29, pp. 387-402 (2003).
Mascoli et al.,Limulus amebocytelysate (LAL) test for detecting pyrogens in parenteral injectable products and medical devices: advantages to manufacturers and regulatory officials,J. Parenter Drug Assoc., 33(2):81-95 (1979).
Moesby et al., A comparative study of Mono Mac 6 cells, isolated mononuclear cells andLimulus amoebocytelysate assay in pyrogen testing,Internal. J. Pharmaceut. 191:141-9 (1999).
Moesby et al., Ultrasonication of pyrogenic microorganisms improves the detection of pyrogens in the Mono Mac 6 assay,Eur. J. Pharmaceut. Sci. 11: 51-7 (2000).
Moltz , Fever: Causes and consequences,Neurosci. Biobeha y. Rev., 17: 237-69 (1993).
Nakagawa, Evaluation of the in vitro pyrogen test system based on proinflammatory cytokine release form human monocytes: Comparison with a human whole blood culture test system and with the rabbit pyrogen test,Clin. Diag. Lab. Immunol., 9(3):588-97 (2002).
Nerad et al., Interleukin-1p (IL-113), IL-1 receptor antagonist, and INFa production in whole blood, J. Leuk. Biol. 52: 687-92 (1992).
Peterbauer et al., Interferon-y-primed monocytoid cell lines: optimizing their use for in vitro detection of bacterial pyrogens,J. Immunol. Meth. 8488 (1999).
Peterbauer et al., Neopterin and nitrite in supernatants from interferon-y-treated monocytoid cell lines: A tool to identify bacterial pyrogens,Pteridines, 10:112-8 (1999).
Pool et al., The detection of pyrogens in blood products using an ex vivo whole blood culture assay,J. Immunoassay, 19(2&3): 95-111 (1998).
Poole et al. A rapid ‘one-plate’ in vitro test for pyrogens.J. Immunol. Meth. 274(1-2):209-20 (2003).
Poole et al., Towards a ‘human pyrogen test’,Eur. J. Parent. Sci. 6(2):63-4 (2001).
Rose et al., Eds., Manual of Clinical Laboratory Immunology, Sixth Edition. ASM Press. Washington, DC. pp. 323 and 326 (2002).
Roslansky et al., Sensitivity ofLimulus amebocytelysate (LAL) to LAL-reactive glucans,J. Clin. Microbiol. 29(11): 2477-83 (1991).
Rothwell, CNS regulation of thermogenesis,Crit. Rev. Neurobiol. 8(1/2):1-10 (1994).
Taktak et al., Assay of pyrogens by interleukin-6 release from monocytic cell lines,J. Pharm. Pharmacol., 43:578-82 (1991).
Tilders et al., Activation of the hypothalamus-pituitary-adrenal axis by bacterial endotoxins: routes and intermediate signals,Psychoneuroendocrinology, 19(2): 209-32 (1994).
Tsuchiya et al., Establishment and characterization of a human acute monocytic leukemia cell line (THP-1),Int. J. Cancer, 26:171-6 (1980).
Yamamoto et al., A cell line assay system for predicting the response of human blood to endotoxin,Jpn. J. Infect. Dis., 56 (3):93-100 (2003).
Zeisberger et al., Neurobiological concepts of fever generation and suppression,Neuropsychobiology, 28:106-9 (1993).
Ziegler-Heitbrock et al., Establishment of a human cell line (Mono Mac 6) with of mature monocytes,Int. J. Cancer, 41:456-61 (1988).
*De Groote et al., Direct stimulation of cytokines (IL-1β, TNF-α, IL-6, IL-2, IFN-μ and GM-CSF) in whole blood. I. Comparison with isolated PBMC stimulation.Cytokine, 4(3): 239-48 (1992).
*EDTNA/ERCA Guidelines: Technical Section,EDTNA/ERCA J. 28(3): 107-15 (2002).
*Cruse et al., Illustrated Dictionary of Immunology, CRC Press, Inc., pp. 83, 248 (1995).
*Harris et al., Detection of endotoxin in triglyceride-rich lipoproteins in vitro,J. Laboratory Clin. Med., 118:186-93 (1991).
*Emancipator et al., In vitro inactivation of bacterial endotoxin by human lipoproteins and apolipoproteins,Infect. Immun., 60:596-601 (1992).

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