메뉴 건너뛰기




Volumn 49, Issue 4, 2009, Pages 1014-1020

Complement dependent cytotoxicity (CDC) activity of a humanized anti Lewis-Y antibody: FACS-based assay versus the 'classical' radioactive method-Qualification, comparison and application of the FACS-based approach

Author keywords

CDC; FACS; Lewis Y; Potency; Qualification

Indexed keywords

CHROMIUM 51; COMPLEMENT; IMMUNOGLOBULIN FC FRAGMENT; LEWIS Y ANTIGEN; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY IGN311; TUMOR ANTIGEN; UNCLASSIFIED DRUG;

EID: 62849128991     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2009.01.029     Document Type: Article
Times cited : (7)

References (22)
  • 5
    • 0042346042 scopus 로고    scopus 로고
    • Di Gaetano. J. Immunol. 171 (2003) 1581-1587
    • (2003) J. Immunol. , vol.171 , pp. 1581-1587
    • Di Gaetano1
  • 12
    • 62849126536 scopus 로고    scopus 로고
    • Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, February 28, 1997.
    • Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, February 28, 1997.
  • 13
    • 62849100957 scopus 로고    scopus 로고
    • Guideline for Industry ICH Q5C. 1996. Quality of biotechnological products: stability testing of biotechnological/biological products.
    • Guideline for Industry ICH Q5C. 1996. Quality of biotechnological products: stability testing of biotechnological/biological products.
  • 15
    • 62849109163 scopus 로고    scopus 로고
    • International Conference on Harmonisation Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biologics Products. 1999. Federal Register 64:44928.
    • International Conference on Harmonisation Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biologics Products. 1999. Federal Register 64:44928.
  • 22
    • 62849094159 scopus 로고    scopus 로고
    • Guidance for Industry Q1A Stability Testing of New Drug Substances and Products. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), August 2001.
    • Guidance for Industry Q1A Stability Testing of New Drug Substances and Products. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), August 2001.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.