메뉴 건너뛰기




Volumn 7, Issue 11, 2015, Pages 1389-1395

Bioanalytical method validation considerations for LC-MS/MS assays of therapeutic proteins

Author keywords

[No Author keywords available]

Indexed keywords

BINDING AFFINITY; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN BINDING; PROTEIN STABILITY; RECEPTOR BINDING ASSAY; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SHORT SURVEY; VALIDATION PROCESS; HUMAN; METABOLISM; PROCEDURES; TANDEM MASS SPECTROMETRY; VALIDATION STUDY;

EID: 84933557104     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.15.69     Document Type: Short Survey
Times cited : (31)

References (13)
  • 1
    • 81055125456 scopus 로고    scopus 로고
    • Absolute quantitation of protein therapeutics in biological matrices by enzymatic digestion and LC-MS
    • Li F, Fast D, Michael S. Absolute quantitation of protein therapeutics in biological matrices by enzymatic digestion and LC-MS. Bioanalysis 3(21), 2459-2480 (2011).
    • (2011) Bioanalysis , vol.3 , Issue.21 , pp. 2459-2480
    • Li, F.1    Fast, D.2    Michael, S.3
  • 2
    • 79959485825 scopus 로고    scopus 로고
    • Bioanalytical approaches to analyzing peptides and proteins by LC-MS/MS
    • Ewles M, Goodwin L. Bioanalytical approaches to analyzing peptides and proteins by LC-MS/MS. Bioanalysis 3(12), 1379-1397 (2011).
    • (2011) Bioanalysis , vol.3 , Issue.12 , pp. 1379-1397
    • Ewles, M.1    Goodwin, L.2
  • 3
    • 84906940191 scopus 로고    scopus 로고
    • A critical review of trypsin digestion for LC- MS Based proteomics
    • Leung HC (Ed.) Tech Publishers, Shanghai, China
    • Hustoft H, Malerod H, Wilson S, Reubsaet L, Lundanes E, Greibrokk T. A critical review of trypsin digestion for LC- MS Based proteomics In: Integrative Proteomics. Leung HC (Ed.) Tech Publishers, Shanghai, China. 73-92 (2012).
    • (2012) Integrative Proteomics , pp. 73-92
    • Hustoft, H.1    Malerod, H.2    Wilson, S.3    Reubsaet, L.4    Lundanes, E.5    Greibrokk, T.6
  • 4
    • 84856900264 scopus 로고    scopus 로고
    • Replacing immunoassays with digestion-peptide immunoaffinity enrichment and LC-MS/MS
    • Becker J, Hoofnagle A. Replacing immunoassays with digestion-peptide immunoaffinity enrichment and LC-MS/MS. Bioanalysis 4(3) 281-290 (2012).
    • (2012) Bioanalysis , vol.4 , Issue.3 , pp. 281-290
    • Becker, J.1    Hoofnagle, A.2
  • 5
    • 79953305842 scopus 로고    scopus 로고
    • Evaluation of large scale quantitative proteomic assay development using peptide affinity-based mass spectrometry
    • Whiteaker J, Zhao L, Abbatiello S et al. Evaluation of large scale quantitative proteomic assay development using peptide affinity-based mass spectrometry. Mol. Cell. Proteomics 10(4), 1-10 (2011).
    • (2011) Mol. Cell. Proteomics , vol.10 , Issue.4 , pp. 1-10
    • Whiteaker, J.1    Zhao, L.2    Abbatiello, S.3
  • 6
    • 84906699468 scopus 로고    scopus 로고
    • Validation of LC-MS/MS bioanalytical methods for protein therapeutics
    • Vazvaei F, Duggan JX. Validation of LC-MS/MS bioanalytical methods for protein therapeutics. Bioanalysis 6(13), 1739-1742 (2014).
    • (2014) Bioanalysis , vol.6 , Issue.13 , pp. 1739-1742
    • Vazvaei, F.1    Duggan, J.X.2
  • 7
    • 84933534426 scopus 로고    scopus 로고
    • European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). www.ema.europa.eu
  • 11
    • 84964313903 scopus 로고    scopus 로고
    • Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics
    • Jenkins R, Duggan J, Aubry AF et al. Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics. AAPS J. 17(1), 1-16 (2015).
    • (2015) AAPS J. , vol.17 , Issue.1 , pp. 1-16
    • Jenkins, R.1    Duggan, J.2    Aubry, A.F.3
  • 12
    • 84885004683 scopus 로고    scopus 로고
    • LC-MS/MS of large molecules in a regulated bioanalytical environment - Which acceptance criteria to apply?
    • Knutsson M, Schmidt R, Timmerman P. LC-MS/MS of large molecules in a regulated bioanalytical environment - which acceptance criteria to apply? Bioanalysis 5(18), 2211-2214 (2013).
    • (2013) Bioanalysis , vol.5 , Issue.18 , pp. 2211-2214
    • Knutsson, M.1    Schmidt, R.2    Timmerman, P.3
  • 13
    • 84900308760 scopus 로고    scopus 로고
    • Ligand binding assay critical reagents and their stability: Recommendations and best practices from the Global Bioanalysis Consortium Harmonization Team
    • King LE, Farley E, Imazato M et al. Ligand binding assay critical reagents and their stability: recommendations and best practices from the Global Bioanalysis Consortium Harmonization Team. AAPS J. 16(3), 504-515 (2014).
    • (2014) AAPS J. , vol.16 , Issue.3 , pp. 504-515
    • King, L.E.1    Farley, E.2    Imazato, M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.