Validation of a capillary isoelectric focusing method for the recombinant monoclonal antibody C2B8

Journal of Chromatography A

Volumn 800, Issue 2, 1998, Pages 355-367

  Hunt, G ^a   Hotaling, T ^a   Chen, A B ^a  

^a GENENTECH INC   (United States)

Author keywords

C2B8; Isoelectric focusing; Monoclonal antibodies; Proteins; Validation

Indexed keywords

CD20 ANTIGEN; MONOCLONAL ANTIBODY;

ANTIBODY DETECTION; ARTICLE; DIAGNOSTIC ACCURACY; ISOELECTRIC FOCUSING; PRIORITY JOURNAL; PROTEIN DETERMINATION;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIGENS, CD20; CIRCADIAN RHYTHM; HUMANS; IODINE RADIOISOTOPES; ISOELECTRIC FOCUSING; LINEAR MODELS; MICE; RECOMBINANT FUSION PROTEINS; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SURFACE PROPERTIES; TEMPERATURE; TIME FACTORS;

EID: 0032571445     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0021-9673(97)01134-5     Document Type: Article

References (21)

1. Costello M.A., Woititz C., DeFeo J., Stremlo D., Wen L.-F.L., Palling D.J., Iqbal K., Guzman N. J. Liq. Chromatogr. 15:1992;1081.
2. Silverman C., Komar M., Shields K., Diegnan G., Adamovics J. J. Liq. Chromatogr. 15:1992;207.
3. Pritchett T.J. BioPharm. 8:1995;38.
4. Z. El Rassi, W. Nashabeh, in: Z. El Rassi, (Ed.), Carbohydrate Analysis: High-Performance Liquid Chromatography and Capillary Electrophoresis, Elsevier, Amsterdam, 1995, p. 283.
5. D. Allen et al., Validation of Peptide Mapping for Protein Identity and Genetic Stability, Biologicals, 1996, Vol. 24, pp. 255-275.
6. Pande P.G., Nellore R.V., Bhagat H.R. Anal. Biochem. 204:1992;103.
7. Nellore R., Bhagat H.R. J. Pharm. Biomed. Anal. 12:1994;1363.
8. Dupin P., Galinou F., Bayol A. J. Chromatogr. A. 707:1995;396.
9. International Conference on Harmonisation. Guideline on validation of analytical procedures: definition and terminology. Fed. Reg. 60(40) (March 1, 1995) 11260-11262.
10. Altria K.D., Goodall D.M., Rogan M.M. Electrophoresis. 15:1994;824.
11. Altria K.D., Walsh A.R., Smith N.W. J. Chromatogr. 645:1993;193.
12. Altria K.D., Harden R.C., Hart M., Hevizi J., Hailey P.A., Makwana J.V., Portsmouth M.J. J. Chromatogr. 641:1993;147.
13. K. Altria. in: K. Altria (Ed.), Methods in Molecular Biology Vol. 52, Humana Press, p. 83.
14. International Conference on Harmonisation. Validation of analytical procedures: methodology, step 2. The Third International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 1995 Nov 29-Dec 1; Yokohama, Japan. Geneva: ICH Secretariat (c/o IFPMA), 1995.
15. Rodriguez-Diaz R., Zhu M., Wehr T. J. Chromatogr. A. 772:1997;145.
16. P.G. Righetti, M. Chiari, in: N.A. Guzman (Ed.), Capillary Electrophoresis Technology, Marcel Dekker, New York, 1993, p. 89.
17. Hunt G., Moorhouse K.G., Chen A.B. J. Chromatogr. A. 744:1996;295.
18. Huang T.-L., Shieh P.C.H., Cooke N. Chromatographia. 39:1994;543.
19. Moorhouse K.G., Rickel C.A., Hunt G., Chen A.B. J. Chromatogr. A. 717:1995;61.
20. Validation of Compendial Methods, United States Pharmacopaeia, 1995, Vol. 23, p. 1982.
21. Moorhouse K.G., Rickel C.A., Chen A.B. Electrophoresis. 17:1996;423.