A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins

Journal of Pharmaceutical and Biomedical Analysis

Volumn 53, Issue 3, 2010, Pages 729-734

  Ray, Chad A ^b   Zhou, Lei ^a   Tsoi, Jennifer ^a   Uy, Lennie ^a   Gu, Jessie ^a   Malella, Jennifer ^a   DeSimone, Danielle ^a   Gunn, Han ^a   Ma, Mark ^a   Lee, Jean ^a   DeSilva, Binodh ^a  

^a AMGEN INC   (United States)

^b Radix BioSolutions   (United States)

Author keywords

Bioanalytical comparability; Ligand binding assay; Pharmacokinetics.

Indexed keywords

PROTEIN;

ARTICLE; ASSAY; BINDING SITE; IMMUNOASSAY; LABORATORY; LIGAND BINDING; PRIORITY JOURNAL; PROSPECTIVE STUDY;

ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; LIGANDS; PROSPECTIVE STUDIES; PROTEINS; QUALITY CONTROL;

EID: 77954860747     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.04.022     Document Type: Article

References (8)

1. Findlay J.W., Smith W.C., Lee J.W., Nordblom G.D., Das I., DeSilva B.S., Khan M.N., Bowsher R.R. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 2000, 21:1249-1273.
2. DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., Celniker A. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 2003, 20:1885-1900.
3. Smolec J., DeSilva B., Smith W., Weiner R., Kelly M., Lee B., Khan M., Tacey R., Hill H., Celniker A., Shah V., Bowsher R., Mire-Sluis A., Findlay J.W., Saltarelli M., Quarmby V., Lansky D., Dillard R., Ullmann M., Keller S., Karnes H.T. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm. Res. 2005, 22:1425-1431.
4. Beaver C. Challenges in Transferring Bioanalytical Methods. Drug Discov. World 2008, 2-6.
5. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: definitions and terminology, Geneva (1996).
6. General Chapter <1225>, Validation of compendial methods,United States Pharmacopeia XXIII, National Formulary, XVIII, Rockville, MD, The United States Pharmacopeial Convention, Inc, 1995, pp. 1710-1612.
7. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., Weiner R. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm. Res. 2007, 24:1962-1973.
8. Weykamp C.W., Penders T.J., Miedema K., Muskiet F.A., van der Slik W. Standardization of glycohemoglobin results and reference values in whole blood studied in 103 laboratories using 20 methods. Clin. Chem. 1995, 41:82-86.