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Volumn 848, Issue 1, 2007, Pages 79-87

Process analytics for purification of monoclonal antibodies

Author keywords

Analytical methods; Antibodies; Process analytical technology; Purification

Indexed keywords

BIOASSAY; DRUG PRODUCTS; ELECTROPHORESIS; LIQUID CHROMATOGRAPHY; PURIFICATION;

EID: 33847631290     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2006.11.018     Document Type: Review
Times cited : (73)

References (25)
  • 1
    • 33847640556 scopus 로고    scopus 로고
    • Food and Drug Administration, Guidance for Industry, PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, 2004 (http://www.fda.gov/cder/guidance/published.html).
  • 2
    • 33847612405 scopus 로고    scopus 로고
    • European Medicines Agency, Mandate for Joint Team of QWP/Ad Hoc GMP Inspectors Group for Process Analytical Technology, Ref.: EMEA/35146/04, 2004.
  • 16
    • 33847649567 scopus 로고    scopus 로고
    • WHO Guideline Requirements for Use of Animal Cells as in Vitro Substrates for the Production of Biologicals. Requirements for Biological Substances No. 50, 1997.
  • 21
    • 33847623692 scopus 로고    scopus 로고
    • CPMP, Position statement on the use of tumourigenic cells of human origin for the production of biological and biotechnological medicinal products, 2001.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.