An immunoligand assay for quantitation of process specific Escherichia coli host cell contaminant proteins in a recombinant bovine somatotropin

Journal of Immunoassay

Volumn 18, Issue 1, 1997, Pages 49-65

  Whitmire, Monica L ^a   Eaton, Leslie C ^a  

^a PFIZER INC   (United States)

Author keywords

biopharmaceutical; bovine somatotropin; host cell contaminant protein; immunoligand assay; proprietary immunoreagent

Indexed keywords

ANTIGEN; CELL PROTEIN; POLYCLONAL ANTIBODY; REAGENT; RECOMBINANT GROWTH HORMONE;

ACCURACY; ARTICLE; CONTAMINATION; ESCHERICHIA COLI; HOST CELL; IMMUNOASSAY; NONHUMAN; PURIFICATION; QUANTITATIVE ASSAY;

EID: 0031056718     PISSN: 01971522     EISSN: None     Source Type: Journal    
DOI: 10.1080/01971529708005804     Document Type: Article

References (18)

1. Eaton, L.C. Host Cell Contaminant Protein Assay Development for Recombinant Biopharmaceuticals. J. Chromatogr A 1995; 705: 105-14.
2. Tollakson, S.L., Anderson, N.L. and Andersen, G.A. Operation of the ISODALT System. Document ANL-BIM-81-1. Argonne National Laboratory. Argonne, Illinois, 1981.
3. International Harmonisation Document. Stage 3 Proposal. Total Protein Assay. Method IV. Pharmeuropa. 1995; 7(4): 561-5.
4. Thalhammer, J. and Freund, Johann. Passive Immunization: A Method of Enhancing the Immune Response Against Antigen Mixtures. J. Immunol. Methods. 1985; 80: 7-13.
5. Anicetti, V.R., Simonetti, M.A., Blackwood, L.L., Jones, A.J.S. and Chen, A.B. Immunization Procedures for E. coli Proteins. Appl. Biochem. Biotechnol. 1989; 22: 151-68.
6. Affi-Gel ™ HZ Immunoaffinity Kit Instruction Manual. Bio-Rad Cat. No. 153-6060. Lit. No. 101-90-0152 390.
7. Hermanson, G. T., Krishna-Mallia, A. and Smith, P.K. in: Immobilized Affinity Ligand Techniques Chapter 5.1.6. Purification of Immunoglobulins Using Protein A, Protein G, or Protein A/G. Academic Press, Inc., 1992. 331 3.
8. Millipore. Protein Blotting Protocols for the Immobilon-P™ Transfer Membrane. 1990. Lit. No. TP001.
9. Threshold™ Application Note #10. Host Cell-Derived Protein (HOP) Assays Using the Threshold™ Immunoligand Assay System. Molecular Devices Corporation, Sunnyvale, CA. 1991.
10. Hafeman, D.G., Parce, J.W. and McConnell, H.M. Light-Addressable Potentiometric Sensor for Biochemical Systems. Science. 1988; 240: 1182-5.
11. Kung, V.T., Panfili, P.R., Sheldon, E.L., et al. Picogram Quantitation of Total DNA Using DNA Binding Proteins in a Silicon Sensor-Based System. Anal. Biochem. 1990; 187: 220-7.
12. Molecular Devices Corporation. Threshold™ System Operator's Manual. Part No. 0112-0022, Rev. A.
13. Molecular Devices Corporation. Threshold™ ILA Kit Labeling Instructions. R-3036-2. 1994.
14. Molecular Devices Corporation. Threshold™ Imrmino-Ligand Assay Detection Kit Instructions. R3037-1. 1990.
15. Molecular Devices Corporation. Threshold™ Application Notes. Contaminant Bovine IgG Assay. Immunoligand Assay Series. No. 14. Rev. 0120-0328. 1994.
16. Ekins, R.P. Multi-Analyte Immunoassay. J. Pharm. Biomed. Anal. 1989; 7(2): 155-68.
17. USP XXII, Section 1225. Validation of Compendial Methods. American National Standards Institute, New York, New York. 1990.
18. Food and Drug Administration. Docket No. 95N-0371. Interim Definition and Elimination of Lot-by-Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products. Federal Register. 1995; 60(236): 63048-9.