2014, Number 1
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VacciMonitor 2014; 23 (1)
Structural Characterization of Granulocyte Colony Stimulating Factor, Hebervital
Pérez N, Cruz Y, Moya G, Costa L, Betancourt L, Besada V, Ferrero J, López JL
Language: Spanish
References: 20
Page: 3-10
PDF size: 169.97 Kb.
ABSTRACT
Granulocyte Colony Stimulating Factor (G-CSF) is member of haemopoietic proteins group used in medication. It is obtained by recombination technique since 2000 at the Center for Genetic Engineering and Biotechnology of Cuba, and it is commercialized as Hebervital. It is recommended for patients with malignant tumors, affected by febrile neutropenia, bone marrow suppressor treatment followed by bone marrow transplant, among others. It induces disorders in the biological activity of the mature neutrophils that could increase host defense in response to pathogens like bacterial and fungal infections. The objective of this project was to perform a specific analysis to
determine G-CSF purity and characterization and to demonstrate its comparability with other commercial products. The sample bands pattern in SDS-PAGE, the area percentage and the chromatographic profiles under the curves, in reverse phase high performance liquid chromatographic were similar. The enzymatic digestion and separation by proteolysis of peptides generated reproduces peptide's maps of great similarity with Neupogen.
REFERENCES
Shoemaker CW, Ayres MS, Grenvik GA, Holbrook RP. Factores estimulantes de colonias hematopoyéticas. En: Tratado de Medicina Crítica y Terapia Intensiva. 4ta Edición. México D.F: Editorial Médica Panamericana; 2000. p. 531-9.
Tanwar S, Thursz M. Granulocite colony-stimulating factor as a novel adjunct to improve hepatitis B vaccination. World J Hepatol 2010;2(3):136-8.
Saab BY, Sharaf L, Zeidan I, Bizri A. Filgrastim use: evaluation in cancer and critically ill non-cancer patients. Cancer Therapy 2003;1:191-6.
Bernstein HM, Pollock BH, Calhoun DA, Christensen RD. Administration of Recombinant Granulocyte Colony- Stimulating Factor to Neonates with Septicemia: A Meta- Analysis. Journal of Pediatrics 2001;138(6):917-20.
Metcalf D. Hemopoietic regulators. Trends Biochem Sci 1992;17(8):286-9.
Hartung T. Anti-inflammatory effects of granulocyte colonystimulating factor. Curr Opin Hematol 1998;5(3):221-5.
Hartung T. Immunomodulation by colony-stimulating factors. Rev Physiol Biochem Pharmacol 1999;136:1-164.
Souza LM, Boone TC, Gabriole J, Lai PH, Zsebo KM, Murdock DC, et al. Recombinant human granulocyte colony-stimulating factor: effects on normal and leukemic myeloid cells. Science 1986;232:61-5.
Lieschke GJ, Burguess AW. Granulocyte-Macrophage Colonystimulating Factor. New England Journal of Medicine 1992;327:28-35.
Herman A, Boone T, Lu H. Characterization, Formulation, and Stability of Neupogen (Filgrastim), a Recombinant Human Granulocyte-Colony Stimulating Factor. Pharmaceutical Biotechnology 2002;9:303-28.
Georgiou G, Valax P. Isolating inclusion bodies from bacteria. Methods Enzimology 1999;309:48-58.
Lowry OH, Rosebrough NJ, Farr AL, Randall RJ. Protein measurement with the follin phenol reagent. J Biol Chem 1951;193:265-75.
Herman AC, Boone TC. Characterization, formulation and stability of Neupogen (filgrastim), a Recombinant Human Granulocyte-Colony Stimulating Factor. Pharm Biotechnol 1996;9:303-28.
Westermeier R. Electrophoresis in Practice. Fourth revised and enlarged edition. Wenham: Wiley-VCH Verlag GmbH & Co. KGaA; 2005.
Carr D. HPLC as a tool to Purify and Isolated. In: The Handbook of Analysis and Purification of Peptides and Proteins by Reversed-Phase HPLC. 3rd Edition. Hesperia, California: Grace Vydac; 2002.p.40-9.
European Pharmacopeia. Directorate for Quality of Medicines. Filgrastim concentrate solution (2206). European Pharmacopeia 2009;6(3):4142-4.
Sambrook J, Rusell DW. Molecular Cloning: a laboratory manual, Ch 9; 3rd edition. New York: Cold Spring Harbor Laboratory; 2001.
United States Pharmacopeia 35-NF 30. Pharmaceutical Compounding Sterile Preparations, Chapter 797. Rockville: USP-NF General; 2012.p.1-38.
Millipore Corporation. Protein Blotting Applications Guide. Technical Protocol TP001. Bedford (MA): Millipore Corporation; 1997. Disponible en: http://www.fisher.co.uk/ techzone/life/hints/Millipore1.pdf
Towbin H, Staehelin T, Gordon J. Electrophoretic transfer of proteins from polyacrylamide gels to nitrocellulose sheets: procedure and some applications. Proc Natl Acad Sci USA 1979;76(9):4350-4.