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Volumn 27, Issue 7, 2015, Pages 34-43

Defining critical quality attributes for monoclonal antibody therapeutic products

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; MONOCLONAL ANTIBODY;

EID: 84915770463     PISSN: 1542166X     EISSN: 19391862     Source Type: Trade Journal    
DOI: None     Document Type: Article
Times cited : (20)

References (11)
  • 6
    • 84944204170 scopus 로고    scopus 로고
    • Characterization and Specifications for Monoclonal Antibodies and Related Products, EMEA/CHMP/BWP/157653/2007
    • EMA, Guideline on Development, Production, Characterization and Specifications for Monoclonal Antibodies and Related Products, EMEA/CHMP/BWP/157653/2007 (December 2008).
    • (2008) EMA, Guideline on Development, Production
  • 9
    • 77958045373 scopus 로고    scopus 로고
    • CMC Biotech Working Group, accessed June 5, 2014
    • CMC Biotech Working Group, A-Mab: A Case Study in Bioprocess Development. October 2009, www.casss.org/associations/9165/files/A-Mab_Case_Study_Version_2-1.pdf, accessed June 5, 2014.
    • (2009) A-Mab: A Case Study in Bioprocess Development


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.