메뉴 건너뛰기




Volumn , Issue SUPPL., 2007, Pages 20-25

Advances in the validation of chromatographic processes

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY; PLASMID DNA;

EID: 33847126075     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (3)

References (13)
  • 1
    • 33847110526 scopus 로고    scopus 로고
    • International Conference on Harmonization, Geneva, Switzerland;
    • International Conference on Harmonization. Q8, pharmaceutical development. Geneva, Switzerland; 2005.
    • (2005) Q8, pharmaceutical development
  • 2
    • 33847138821 scopus 로고    scopus 로고
    • International Conference on Harmonization, Geneva, Switzerland;
    • International Conference on Harmonization. Q9, quality risk management. Geneva, Switzerland; 2005.
    • (2005) Q9, quality risk management
  • 3
    • 10844248476 scopus 로고    scopus 로고
    • A rational, step wise approach to process characterization
    • Seely JE, Seely RJ. A rational, step wise approach to process characterization. BioPharm Int. 2003;16(8):24-34.
    • (2003) BioPharm Int , vol.16 , Issue.8 , pp. 24-34
    • Seely, J.E.1    Seely, R.J.2
  • 4
    • 33847148294 scopus 로고    scopus 로고
    • Development of a bio-derived drug
    • Murtagh J. Development of a bio-derived drug. Contract pharma. 2006;8(3):70-75.
    • (2006) Contract pharma , vol.8 , Issue.3 , pp. 70-75
    • Murtagh, J.1
  • 6
    • 0037027379 scopus 로고    scopus 로고
    • Impact of cell culture process changes on endogenous retroviral expression
    • Brorson K, et al. Impact of cell culture process changes on endogenous retroviral expression. Biotechnol. bioeng. 2002;80(3):257-67.
    • (2002) Biotechnol. bioeng , vol.80 , Issue.3 , pp. 257-267
    • Brorson, K.1
  • 7
    • 33847173586 scopus 로고    scopus 로고
    • Application Note 28-4078-17 AA, Capto S cation exchanger for post-protein A purification of monoclonal antibodies. Chalfont St. Giles, UK; 2006.
    • Application Note 28-4078-17 AA, Capto S cation exchanger for post-protein A purification of monoclonal antibodies. Chalfont St. Giles, UK; 2006.
  • 8
    • 33847099426 scopus 로고    scopus 로고
    • Guidance for industry
    • and Drug Administration, Rockville, MD; May
    • US Food and Drug Administration. Guidance for industry. General principles of process validation. Rockville, MD; May 2006.
    • (2006) General principles of process validation
    • Food, U.S.1
  • 9
    • 24644453019 scopus 로고    scopus 로고
    • Efficiency measurements for chromatography columns
    • Rathore A. Efficiency measurements for chromatography columns. BioPharm Int. 2005;18(8):58-64.
    • (2005) BioPharm Int , vol.18 , Issue.8 , pp. 58-64
    • Rathore, A.1
  • 10
    • 33847150783 scopus 로고    scopus 로고
    • US Food and Drug Administration. Therapeutic compliance guide. 7341.001.
    • US Food and Drug Administration. Therapeutic compliance guide. 7341.001.
  • 11
    • 15044344530 scopus 로고    scopus 로고
    • Impact of multiple re-use of anion-exchange chromatography media on virus removal
    • Norling L, et al. Impact of multiple re-use of anion-exchange chromatography media on virus removal. J Chrom A. 2005;1069(1):79-89.
    • (2005) J Chrom A , vol.1069 , Issue.1 , pp. 79-89
    • Norling, L.1
  • 12
    • 0347928638 scopus 로고    scopus 로고
    • Identification of protein A media performance attributes that can be monitored as surrogates for retrovirus clearance during extended re-use
    • Brorson K, et al. Identification of protein A media performance attributes that can be monitored as surrogates for retrovirus clearance during extended re-use. J Chrom A. 2003;989(1):153-163.
    • (2003) J Chrom A , vol.989 , Issue.1 , pp. 153-163
    • Brorson, K.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.