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Volumn 9, Issue 4, 2006, Pages 34-43

Applying selective biophysical techniques in assessing the comparability of protein therapeutics - Case studies

Author keywords

[No Author keywords available]

Indexed keywords

CIRCULAR DICHROISM; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG MANUFACTURE; FLUORESCENCE ANALYSIS; INFRARED SPECTROSCOPY; MOLECULAR INTERACTION; PARTICLE SIZE; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN CONFORMATION; PROTEIN SECONDARY STRUCTURE; PROTEIN STABILITY; PROTEIN STRUCTURE; PROTEIN TERTIARY STRUCTURE; REVIEW; SCREENING TEST; THERMOSTABILITY; ULTRACENTRIFUGATION;

EID: 55749108733     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (3)

References (8)
  • 1
    • 55749094447 scopus 로고    scopus 로고
    • FDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnologyderived products, CBER and CDER, April, 1996.
    • FDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnologyderived products, CBER and CDER, April, 1996.
  • 2
    • 8344224534 scopus 로고    scopus 로고
    • Characterizing biological products and assessing comparability following manufacturing changes
    • Chirino A.J. and Mire-Sluis A., Characterizing biological products and assessing comparability following manufacturing changes, Nature Biotechnology, 22 (11), 1383-1391, 2004.
    • (2004) Nature Biotechnology , vol.22 , Issue.11 , pp. 1383-1391
    • Chirino, A.J.1    Mire-Sluis, A.2
  • 3
    • 0141567459 scopus 로고    scopus 로고
    • Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation
    • Chi E. Y., Krishnan S., Randolph T. W. and Carpenter J. F., Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation, Pharmaceutical research, 20 (9), 1325-1336, 2003.
    • (2003) Pharmaceutical research , vol.20 , Issue.9 , pp. 1325-1336
    • Chi, E.Y.1    Krishnan, S.2    Randolph, T.W.3    Carpenter, J.F.4
  • 6
    • 0031011382 scopus 로고    scopus 로고
    • Size and conformational stability of the hepatitis A virus used to prepare VAQTA, a highly purified inactivated vaccine
    • Volkin D.B., Burke C. J., Marfia K., Oswald C. B., Wolanski B., and Middaugh C.R., Size and conformational stability of the hepatitis A virus used to prepare VAQTA, a highly purified inactivated vaccine, Journal of pharmaceutical sciences, 86 (6), 666-673, 1997.
    • (1997) Journal of pharmaceutical sciences , vol.86 , Issue.6 , pp. 666-673
    • Volkin, D.B.1    Burke, C.J.2    Marfia, K.3    Oswald, C.B.4    Wolanski, B.5    Middaugh, C.R.6
  • 8
    • 0036187342 scopus 로고    scopus 로고
    • Effect of the intermolecular disulfide bond on the conformation and stability of glial cell line-derived neurotrophic factor
    • Li T. Yamane H. Arakawa T. Narhi LO. Philo J. Effect of the intermolecular disulfide bond on the conformation and stability of glial cell line-derived neurotrophic factor., Protein Engineering, 15(1): 59- 64, 2002.
    • (2002) Protein Engineering , vol.15 , Issue.1 , pp. 59-64
    • Li, T.1    Yamane, H.2    Arakawa, T.3    Narhi, L.O.4    Philo, J.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.