Characterization and viral safety validation study of a pasteurized therapeutic concentrate of antithrombin III obtained through affinity chromatography

Haematologica

Volumn 83, Issue 4, 1998, Pages 305-311

  Biescas, Herminia ^a   Gensana, Marta ^a   Fernández, Jesús ^a   Ristol, Pere ^a   Massot, Marta ^a   Watson, Elisabeth ^b   Vericat, Fernando ^a  

^a Instituto Grifols   (Spain)

^b Q One Biotech Ltd   (United Kingdom)

Author keywords

Affinity purification; Antithrombin III; Pasteurization; Therapeutic concentrate; Viral safety validation

Indexed keywords

ALBUMIN; ANTITHROMBIN III CONCENTRATE; IMMUNOGLOBULIN G;

AFFINITY CHROMATOGRAPHY; ARTICLE; BOVINE DIARRHEA VIRUS; BOVINE HERPES VIRUS; CLINICAL PROTOCOL; DRUG PURIFICATION; ENCEPHALOMYOCARDITIS VIRUS; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; PASTEURIZATION; PRACTICE GUIDELINE; SUPERNATANT; VALIDATION PROCESS; VIRUS INACTIVATION;

ANTITHROMBIN III; CHROMATOGRAPHY, AFFINITY; EVALUATION STUDIES; HUMANS; SAFETY; STERILIZATION; VIRUS DISEASES;

EID: 0031977308     PISSN: 03906078     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (16)

1. Giddings JC. Molecular genetics and immunoanalysis in blood coagulation. Chichester:VCH; 1988.
2. nd ed. New York; 1992.
3. Menaché D, Grossman BJ, Jackson M. Antithrombin III: physiology, deficiency and replacement therapy. Transfusion 1992; 32:580-8.
4. Lechner K, Kyrle PA. Antithrombin III concentrates - Are they clinically useful? Thromb Haemostasis 1995; 73:340-8.
5. Miller-Andersson M, Borg H, Anderson LO. Purification of antithrombin III by affinity chromatography. Thromb Res 1974; 5:439-52.
6. Cohn EJ, Strong LE, Hughes Jr. WL, et al. Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and Fluids. J Am Chem Soc 1946; 68:459-75.
7. Wickerhauser M, Williams C, Mercer J. Development of large scale fractionation methods. Preparation of antithrombin III concentrate. Vox Sang 1979; 36:281-93.
8. Dodd RY. Transfusion-transmitted hepatitis virus infection. Transf Med II 1995; 9:137-154.
9. EEC CPMP Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines Notes for Guidance. Validation of virus removal and Inactivation Procedures. Biologicals 1991; 19:247-51.
10. EEC CPMP Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines Notes for Guidance. Medicinal Products Derived from Human Blood and Plasma. Biologicals 1992; 20:159-64.
11. Karber J. Beitrag zur kollectiven Behandlung pharmakologische Reihenversuche. Arch Exp Pathol Pharmak 1931; 162:480-3.
12. Klement V, Nicholson MO. Methods for assays of RNA tumor viruses. In: Maramorosch K, Koprowski H, eds. Methods in Virology, VI. London: Academic Press, 1977. p. 59-108.
13. Chang WSW, Harper PL Commercial antithrombin concentrate contains inactive L-forms of antithrombin. Thromb Haemost 1997; 77:323-8.
14. Harper PL, Evans D, Carrell RW. The potential hazards of antithrombin preparations. Thromb Haemost 1991; 65:914.
15. Daly M, Hallinan F. Analysis of antithrombin III microheterogeneity by isoelectric focusing in poliacrylamide gels and immunoblotting. Thromb Res 1985; 40:207-14.
16. th Edition. London: JS Portfiefd, B. Tindall, 1989. p. 166-213, 293-332, 62-76, 120-45.