메뉴 건너뛰기




Volumn 53, Issue 3, 2010, Pages 262-268

Correlation of liquid chromatographic and biological assay for potency assessment of filgrastim and related impurities

Author keywords

Biological assay; Chromatography; Correlation; Filgrastim; Impurities

Indexed keywords

DIMER; FORMYLMETHIONINE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

EID: 77954861342     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.02.006     Document Type: Article
Times cited : (20)

References (28)
  • 2
    • 0035823594 scopus 로고    scopus 로고
    • Reengineering granulocyte colony-stimulating factor for enhanced stability
    • Bishop B., Koay D.C., Sartorelli A.C., Regan L. Reengineering granulocyte colony-stimulating factor for enhanced stability. J. Biol. Chem. 2001, 33465-33470.
    • (2001) J. Biol. Chem. , pp. 33465-33470
    • Bishop, B.1    Koay, D.C.2    Sartorelli, A.C.3    Regan, L.4
  • 3
    • 0022419320 scopus 로고
    • The granulocyte-macrophage colony-stimulating factors
    • Metcalf D. The granulocyte-macrophage colony-stimulating factors. Science 1985, 229:16-22.
    • (1985) Science , vol.229 , pp. 16-22
    • Metcalf, D.1
  • 4
    • 0033080174 scopus 로고    scopus 로고
    • Chemical modification and site-directed mutagenesis of methionine residues in recombinant human granulocyte colony-stimulating factor: effect on stability and biological activity
    • Lu H., Fausset P., Narhi L., Horan T., Shinagawa K., Shimamoto G., Boone T. Chemical modification and site-directed mutagenesis of methionine residues in recombinant human granulocyte colony-stimulating factor: effect on stability and biological activity. Arch. Biochem. Biophys. 1999, 362:1-11.
    • (1999) Arch. Biochem. Biophys. , vol.362 , pp. 1-11
    • Lu, H.1    Fausset, P.2    Narhi, L.3    Horan, T.4    Shinagawa, K.5    Shimamoto, G.6    Boone, T.7
  • 5
    • 0029928270 scopus 로고    scopus 로고
    • Chemical modification and site-directed mutagenesis of methionine residues in recombinant human granulocyte colony-stimulating factor: effect on stability and biological activity
    • Horan T., Wen J., Narhi L.O., Parker V., Garcia A., Arakawa T., Philo J. Chemical modification and site-directed mutagenesis of methionine residues in recombinant human granulocyte colony-stimulating factor: effect on stability and biological activity. Biochemistry 1996, 35:4886-4896.
    • (1996) Biochemistry , vol.35 , pp. 4886-4896
    • Horan, T.1    Wen, J.2    Narhi, L.O.3    Parker, V.4    Garcia, A.5    Arakawa, T.6    Philo, J.7
  • 8
    • 77954862976 scopus 로고
    • Production of pluripotent granulocyte colony-stimulating factor, Patent US 4,810,
    • L. Souza, Production of pluripotent granulocyte colony-stimulating factor, Patent US 4,810,643 (1989).
    • (1989) , pp. 643
    • Souza, L.1
  • 9
    • 77954860669 scopus 로고    scopus 로고
    • Method for purifying granulocyte colony stimulating factor, Patent US 5,849,
    • T.C. Boone, A.L. Miller, J.W. Andresen, Method for purifying granulocyte colony stimulating factor, Patent US 5,849,883 (1998).
    • (1998) , pp. 883
    • Boone, T.C.1    Miller, A.L.2    Andresen, J.W.3
  • 10
    • 77954865222 scopus 로고    scopus 로고
    • Process for the purification and/or isolation of biologically active granulocyte colony stimulating factor, Patent US 2005/01595589.
    • V.G. Porekar, V. Menart, Process for the purification and/or isolation of biologically active granulocyte colony stimulating factor, Patent US 2005/01595589 (2005).
    • (2005)
    • Porekar, V.G.1    Menart, V.2
  • 11
    • 0026786749 scopus 로고
    • Folding and oxidation of recombinant human granulocyte colony stimulating factor produced in Escherichia coli: characterization of the disulfide-reduced intermediates and cysteine-serine analogs
    • Lu H.S., Clogston C.L., Narhi L.O., Merewether L.A., Pearl W.R., Boone T.C. Folding and oxidation of recombinant human granulocyte colony stimulating factor produced in Escherichia coli: characterization of the disulfide-reduced intermediates and cysteine-serine analogs. J. Biol. Chem. 1992, 267:8770-8777.
    • (1992) J. Biol. Chem. , vol.267 , pp. 8770-8777
    • Lu, H.S.1    Clogston, C.L.2    Narhi, L.O.3    Merewether, L.A.4    Pearl, W.R.5    Boone, T.C.6
  • 12
    • 0030338341 scopus 로고    scopus 로고
    • ® (Filgrastim), a recombinant human granulocyte-colony stimulating factor
    • Plenum Press, New York, R.I. Pearlman, Y.J. Wang (Eds.)
    • ® (Filgrastim), a recombinant human granulocyte-colony stimulating factor. Formulation, Characterization, and Stability of Protein Drugs 1996, 303-328. Plenum Press, New York. R.I. Pearlman, Y.J. Wang (Eds.).
    • (1996) Formulation, Characterization, and Stability of Protein Drugs , pp. 303-328
    • Herman, A.C.1    Boone, T.C.2    Lu, H.S.3
  • 13
    • 0033045004 scopus 로고    scopus 로고
    • Relationship between molecular mass and duration of activity of polyethylene glycol conjugated granulocyte colony-stimulating factor mutein
    • Bowen S., Tare N., Inoue T., Yamasaki M., Okabe M., Horii I., Eliason J.F. Relationship between molecular mass and duration of activity of polyethylene glycol conjugated granulocyte colony-stimulating factor mutein. Exp. Hematol. 1999, 27:425-432.
    • (1999) Exp. Hematol. , vol.27 , pp. 425-432
    • Bowen, S.1    Tare, N.2    Inoue, T.3    Yamasaki, M.4    Okabe, M.5    Horii, I.6    Eliason, J.F.7
  • 14
    • 0030159429 scopus 로고    scopus 로고
    • Kinetics of serum granulocyte-colony stimulating factor (G-CSF) concentration and G-CSF receptor expression during G-CSF treatment of cyclophosphamide-treated mice
    • Matsuzaki G., Li X.Y., Ohyama Y., Nomoto K. Kinetics of serum granulocyte-colony stimulating factor (G-CSF) concentration and G-CSF receptor expression during G-CSF treatment of cyclophosphamide-treated mice. Int. J. Immunopharmacol. 1996, 12:363-369.
    • (1996) Int. J. Immunopharmacol. , vol.12 , pp. 363-369
    • Matsuzaki, G.1    Li, X.Y.2    Ohyama, Y.3    Nomoto, K.4
  • 15
    • 0023100463 scopus 로고
    • Effect of human recombinant granulocyte colony-stimulating factor on hematopoietic injury in mice induced by 5-fluorouracil
    • Shimamura M., Kobayashi Y., Yuo A., Urabe A., Okabe T., Komatsu Y., Itoh S., Takaku F. Effect of human recombinant granulocyte colony-stimulating factor on hematopoietic injury in mice induced by 5-fluorouracil. Blood 1987, 69:353-355.
    • (1987) Blood , vol.69 , pp. 353-355
    • Shimamura, M.1    Kobayashi, Y.2    Yuo, A.3    Urabe, A.4    Okabe, T.5    Komatsu, Y.6    Itoh, S.7    Takaku, F.8
  • 16
    • 0028836667 scopus 로고
    • In vitro bioassay with enhanced sensitivity for human granulocyte colony-stimulating factor
    • Hammerling U., Kroon R., Sjödin L. In vitro bioassay with enhanced sensitivity for human granulocyte colony-stimulating factor. J. Pharm. Biomed. Anal. 1995, 13:9-20.
    • (1995) J. Pharm. Biomed. Anal. , vol.13 , pp. 9-20
    • Hammerling, U.1    Kroon, R.2    Sjödin, L.3
  • 17
  • 18
    • 77954862073 scopus 로고    scopus 로고
    • European Pharmacopoeia 6.3. Filgrastim concentrated solution 01/:2206, EDQM.
    • European Pharmacopoeia 6.3. Filgrastim concentrated solution 01/2009:2206, EDQM.
    • (2009)
  • 19
    • 0030424856 scopus 로고    scopus 로고
    • Biological assays: their role in the development and quality control of recombinant biological medicinal products
    • Mire-Sluis A.R., Gerrard T., Das R.G., Padilla A., Thorpe R. Biological assays: their role in the development and quality control of recombinant biological medicinal products. Biologicals 1996, 24:351-362.
    • (1996) Biologicals , vol.24 , pp. 351-362
    • Mire-Sluis, A.R.1    Gerrard, T.2    Das, R.G.3    Padilla, A.4    Thorpe, R.5
  • 20
    • 0030927136 scopus 로고    scopus 로고
    • Comparison of biological and chemical assays for the quantitation of rifapentine in human plasma
    • Kenny M.T., Reynolds D.L., Brackman M.A., Dulworth J.K. Comparison of biological and chemical assays for the quantitation of rifapentine in human plasma. Diagn. Microbiol. Infect. Dis. 1997, 27:107-111.
    • (1997) Diagn. Microbiol. Infect. Dis. , vol.27 , pp. 107-111
    • Kenny, M.T.1    Reynolds, D.L.2    Brackman, M.A.3    Dulworth, J.K.4
  • 21
    • 33745684961 scopus 로고    scopus 로고
    • Validation of RP-HPLC method and assessment of rhG-CSF in pharmaceutical formulation by liquid chromatography and biological assay
    • Dalmora S.L., Massiero S., Oliveira P., Sangoi M., Brum L. Validation of RP-HPLC method and assessment of rhG-CSF in pharmaceutical formulation by liquid chromatography and biological assay. J. Liq. Chromatogr. Relat. Technol. 2006, 29:1753-1767.
    • (2006) J. Liq. Chromatogr. Relat. Technol. , vol.29 , pp. 1753-1767
    • Dalmora, S.L.1    Massiero, S.2    Oliveira, P.3    Sangoi, M.4    Brum, L.5
  • 22
    • 0034983505 scopus 로고    scopus 로고
    • Repeatability and validity of a fluorimetric HPLC method in the quantification of yessotoxin in blue mussels (Mytilus edulis) related to mouse bioassay
    • Ramstadt H., Larsen S., Aune T. Repeatability and validity of a fluorimetric HPLC method in the quantification of yessotoxin in blue mussels (Mytilus edulis) related to mouse bioassay. Toxicon 2001, 39:1393-1397.
    • (2001) Toxicon , vol.39 , pp. 1393-1397
    • Ramstadt, H.1    Larsen, S.2    Aune, T.3
  • 23
    • 0026495517 scopus 로고
    • Analysis of therapeutic growth hormone preparations: report of an interlaboratory collaborative study on growth hormone assay methodologies
    • Bristow A.F., Jeffcoate S.L. Analysis of therapeutic growth hormone preparations: report of an interlaboratory collaborative study on growth hormone assay methodologies. Biologicals 1992, 20:221-231.
    • (1992) Biologicals , vol.20 , pp. 221-231
    • Bristow, A.F.1    Jeffcoate, S.L.2
  • 24
    • 0025211779 scopus 로고
    • Quantitation of protein
    • Deutcher
    • Stoscheck C.M. Quantitation of protein. Methods in Enzymology 1990, volume182:50-68. Deutcher.
    • (1990) Methods in Enzymology , vol.182 , pp. 50-68
    • Stoscheck, C.M.1
  • 25
    • 0014254093 scopus 로고
    • Spectrophotometric determination of microgram quantities of protein without nucleic acid interference
    • Groves W.E., Davis F.C., Sells B.H. Spectrophotometric determination of microgram quantities of protein without nucleic acid interference. Anal. Biochem. 1968, 22:195-210.
    • (1968) Anal. Biochem. , vol.22 , pp. 195-210
    • Groves, W.E.1    Davis, F.C.2    Sells, B.H.3
  • 26
    • 77954863275 scopus 로고    scopus 로고
    • EDQM.
    • Pharmaeuropa 20.4 2008, EDQM, pp. 678-681.
    • (2008) Pharmaeuropa 20.4 , pp. 678-681
  • 27
    • 0027672078 scopus 로고
    • Isolation and characterization of three recombinant human granulocyte colony stimulating factor His→Gln isoforms produced in Escherichia coli
    • Lu H.S., Fausset P.R., Sotos L.S., Clogston C.L., Rohde M.F., Stoney K.S., Herman A.C. Isolation and characterization of three recombinant human granulocyte colony stimulating factor His→Gln isoforms produced in Escherichia coli. Protein Expr. Purif. 1993, 4:465-472.
    • (1993) Protein Expr. Purif. , vol.4 , pp. 465-472
    • Lu, H.S.1    Fausset, P.R.2    Sotos, L.S.3    Clogston, C.L.4    Rohde, M.F.5    Stoney, K.S.6    Herman, A.C.7


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.