Development and validation of a liquid chromatography method for simultaneous determination of three process-related impurities: Yeastolates, triton X-100 and methotrexate

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 879, Issue 30, 2011, Pages 3612-3619

  Fang, Shiping ^a   Lollo, Charles P ^a   Derunes, Celine ^a   LaBarre, Michael J ^a  

^a Halozyme Therapeutics Inc   (United States)

Author keywords

Hyaluronidase; Liquid chromatography; Method validation; Methotrexate; Process related impurities (PRI); RHuPH20; Triton X 100; Yeastolates

Indexed keywords

HYALURONIDASE; METHOD VALIDATIONS; METHOTREXATE; PROCESS-RELATED IMPURITIES; RHUPH20; TRITON X-100; YEASTOLATES;

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIQUIDS;

CHROMATOGRAPHY;

GROWTH PROMOTOR; METHOTREXATE; TRITON X 100; UNCLASSIFIED DRUG; YEASTOLATES;

ARTICLE; DRUG DETERMINATION; HUMAN; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; VIRUS INACTIVATION; YEAST;

CELL ADHESION MOLECULES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, REVERSE-PHASE; CULTURE MEDIA; DRUG CONTAMINATION; HUMANS; HYALURONOGLUCOSAMINIDASE; METHOTREXATE; OCTOXYNOL; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; YEASTS;

EID: 80555122774     PISSN: 15700232     EISSN: 1873376X     Source Type: Journal    
DOI: 10.1016/j.jchromb.2011.10.003     Document Type: Article

References (18)

1. Walsh G. Nat. Biotechnol. 2006, 24:769.
2. Omasa T., Onitsuka M., Kim W.D. Curr. Pharm. Biotechnol. 2010, 11:233.
3. Frost G.I. Expert Opin. Drug Deliv. 2007, 4:427.
4. Donaldson M.S., Shuler M.L. Biotechnol. Prog. 1998, 14:573.
5. Ikonomou L., Bastin G., Schneider Y.J., Agathos S.N. In Vitro Cell Biol. 2001, 37:549.
6. Kotsopoulou E., Bosteels H., Chim Y.T., Pegman P., Stephen G., Thornhill S.I., Faulkner J.D., Uden M. J. Biotechnol. 2010, 146:186.
7. Roberts P.L. Biologicals 2008, 36:330.
8. Vetvicka V., Vashishta A., Saraswat-Ohri S., Vetvickova J. J. Med. Food 2008, 11:615.
9. Jelinek A., Klocking H.P. Exp. Toxicol. Pathol. 1998, 50:472.
10. Chen L.H., Price C.E., Goerke A., Lee A.L., DePhillips P.A. J. Pharm. Biomed. Anal. 2006, 40:964.
11. World Health Organization Technical Report, Series No. 924, Annex 4: guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products, 2004.
12. Panetta J.C., Wall A., Pui C.H., Relling W.V., Evans W.E. Clin. Cancer Res. 2002, 8:2423.
13. Weinblatt M.E. N. Engl. J. Med. 1995, 332:330.
14. Waltham M.C., Lin S., Li W.W., Goker E., Gritsman H., Tong W.P., Bertino J.R. J. Chromatogr. B 1997, 689:387.
15. Kuo C.Y., Wu H.L., Kou H.S., Chiou S.S., Wu D.C., Wu S.M. J. Chromatogr. A 2003, 1014:93.
16. Li H., Luo W., Zeng Q., Lin Z., Luo H., Zhang Y. J. Chromatogr. B 2007, 845:164.
17. Michail K., Moneeb M.S. J. Pharm. Biomed. Anal. 2011, 55:317.
18. Shen C.F., Kiyota T., Jardin B., Konishi Y., Kamen A. Cytotechnology 2007, 54:25.