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Volumn 8, Issue 1, 2010, Pages 18-24

Improved HCP quantitation by minimizing antibody cross-reactivity to target proteins

Author keywords

Cross reactivity; ELISA; Host cell proteins; Risk management; Western blotting

Indexed keywords

ANTIBODY; CELL PROTEIN; DNA; MONOCLONAL ANTIBODY;

EID: 77953469350     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article
Times cited : (18)

References (11)
  • 1
    • 0034074086 scopus 로고    scopus 로고
    • Strategies for Host Cell Protein Analysis
    • Hoffman K. Strategies for Host Cell Protein Analysis. BioPharm 13(6) 2000: 38-45.
    • (2000) BioPharm , vol.13 , Issue.6 , pp. 38-45
    • Hoffman, K.1
  • 2
    • 65549124409 scopus 로고    scopus 로고
    • Host Cell Proteins in Biologics Development: Identification, Quantitation and Risk Assessment
    • Wang X, Hunter AK, Mozier NM. Host Cell Proteins in Biologics Development: Identification, Quantitation and Risk Assessment. Biotechnol. Bioeng. 103(3) 2009: 446-458.
    • (2009) Biotechnol. Bioeng , vol.103 , Issue.3 , pp. 446-458
    • Wang, X.1    Hunter, A.K.2    Mozier, N.M.3
  • 3
    • 4444236379 scopus 로고    scopus 로고
    • A Two-Dimensional Electrophoresis Map of Chinese Hamster Ovary Cell Proteins Based on Fluorescence Staining
    • Hayduk EJ, Choe LH, Lee KH. A Two-Dimensional Electrophoresis Map of Chinese Hamster Ovary Cell Proteins Based on Fluorescence Staining. Electrophor. 25(25) 2004: 2545-2556.
    • (2004) Electrophor , vol.25 , Issue.25 , pp. 2545-2556
    • Hayduk, E.J.1    Choe, L.H.2    Lee, K.H.3
  • 4
    • 0036638067 scopus 로고    scopus 로고
    • Quantitative Evaluation of Proteins in One-and Two-Dimensional Polyacrylamide Gels Using a Fluorescence Stain
    • Nishihara JC, Champion KM. Quantitative Evaluation of Proteins in One-and Two-Dimensional Polyacrylamide Gels Using a Fluorescence Stain. Electrophor. 23(14) 2002: 2203-2215.
    • (2002) Electrophor , vol.23 , Issue.14 , pp. 2203-2215
    • Nishihara, J.C.1    Champion, K.M.2
  • 5
    • 8844219682 scopus 로고    scopus 로고
    • Comparative Proteomic Analysis of GS-NS0 Murine Myeloma Cell Line with Varying Recombinant Monoclonal Antibody Production Rate
    • Smales CM, et al. Comparative Proteomic Analysis of GS-NS0 Murine Myeloma Cell Line with Varying Recombinant Monoclonal Antibody Production Rate. Biotechnol. Bioeng. 88(4) 2004: 474-488.
    • (2004) Biotechnol. Bioeng , vol.88 , Issue.4 , pp. 474-488
    • Smales, C.M.1
  • 6
    • 77953470281 scopus 로고    scopus 로고
    • ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology. Fed. Reg. 62 (96) 1997: 27463-27467.
    • ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology. Fed. Reg. 62 (96) 1997: 27463-27467.
  • 7
    • 0037328020 scopus 로고    scopus 로고
    • Identification of Cellular Changes Associated with Increased Production of Human Growth Hormone in a Recombinant Chinese Hamster Ovary Cell Line
    • Dyk DDV, et al. Identification of Cellular Changes Associated with Increased Production of Human Growth Hormone in a Recombinant Chinese Hamster Ovary Cell Line. Proteomics 3, 2003: 147-156.
    • (2003) Proteomics , vol.3 , pp. 147-156
    • Dyk, D.D.V.1
  • 8
    • 31344443966 scopus 로고    scopus 로고
    • Proteomic Studies Support the Use of Multi-Product Immunoassays to Monitor Host Cell Protein Impurities
    • Krawitz DC, et al. Proteomic Studies Support the Use of Multi-Product Immunoassays to Monitor Host Cell Protein Impurities. Proteomics 6, 2006: 94-110.
    • (2006) Proteomics , vol.6 , pp. 94-110
    • Krawitz, D.C.1
  • 9
    • 37349012594 scopus 로고    scopus 로고
    • Defining Your Product Profile and Maintaining Control Over It, Part 2
    • Champion K, et al. Defining Your Product Profile and Maintaining Control Over It, Part 2. BioProcess Int. 3(8) 2005: 52-57.
    • (2005) BioProcess Int , vol.3 , Issue.8 , pp. 52-57
    • Champion, K.1
  • 10
    • 77953457578 scopus 로고    scopus 로고
    • CPMP/BWP/382/97. CPMP Position Statement on DNA and Host Cell Proteins (HCP) Impurities: Routine Testing Versus Validation Studies. EMEA: London, UK, 10 June 1997; www.emea.europa.eu/pdfs/human/press/pos/038297en.pdf.
    • CPMP/BWP/382/97. CPMP Position Statement on DNA and Host Cell Proteins (HCP) Impurities: Routine Testing Versus Validation Studies. EMEA: London, UK, 10 June 1997; www.emea.europa.eu/pdfs/human/press/pos/038297en.pdf.
  • 11
    • 0004125932 scopus 로고    scopus 로고
    • US Food and Drug Administration: Rockville, MD, 28 February 1997;
    • CBER. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. US Food and Drug Administration: Rockville, MD, 28 February 1997; www.fda.gov/downloads/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/ UCM153182.pdf.
    • Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.