Field-Flow Fractionation in Therapeutic Protein Development
作者： Joey Pollastrini , Linda O. Narhi , Yijia Jiang , Shawn Cao
DOI: 10.1007/978-3-7091-0154-4_5
关键词:
摘要: The development lifecycle for pharmaceutical proteins begins with target identification and demonstration of the biological relevance a particular protein or property, continues to which lead product candidate cell line advance, then proceeds through process formulation characterization, clinical trials commercialization. launch represents beginning different kind support, includes lot release, exploration delivery devices, comparability, support investigations. past several decades have seen documentation utility asymmetrical flow field-flow fractionation (AF4) in biotechnology applicable each these drug phases, but as yet, limited industrial routine implementation. This chapter seeks provide survey such applications potential opportunities inspiration exploitation distinct characteristics AF4 throughout long, winding multifaceted process.
springer.com
sci-hub.st 参考文章(31)
Maya Madörin, Peter van Hoogevest, Rolf Hilfiker, Birgit Langwost, Gerhard M. Kresbach, Markus Ehrat, Hans Leuenberger, Analysis of Drug/Plasma Protein Interactions by Means of Asymmetrical Flow Field-Flow Fractionation Pharmaceutical Research. ,vol. 14, pp. 1706- 1712 ,(1997) , 10.1023/A:1012171511285
Christopher J. Roberts, Wei Wang, Aggregation of therapeutic proteins : Wiley,. ,(2010)
Pharmaceutical project management CRC Press. ,(2008) , 10.3109/9781420013924
Hanns-Christian Mahler, Stefan Fischer, Theodore W. Randolph, John F. Carpenter, Protein Aggregation and Particle Formation: Effects of Formulation, Interfaces, and Drug Product Manufacturing Operations Aggregation of Therapeutic Proteins. pp. 301- 331 ,(2010) , 10.1002/9780470769829.CH7
Wolfgang Fraunhofer, Gerhard Winter, The use of asymmetrical flow field-flow fractionation in pharmaceutics and biopharmaceutics European Journal of Pharmaceutics and Biopharmaceutics. ,vol. 58, pp. 369- 383 ,(2004) , 10.1016/J.EJPB.2004.03.034
A. Litzen, J.K. Walter, H. Krischollek, K.G. Wahlund, Separation and Quantitation of Monoclonal Antibody Aggregates by Asymmetrical Flow Field-Flow Fractionation and Comparison to Gel Permeation Chromatography Analytical Biochemistry. ,vol. 212, pp. 469- 480 ,(1993) , 10.1006/ABIO.1993.1356
Hookeun Lee, S. Kim Ratanathanawongs Williams, J. Calvin Giddings, Particle size analysis of dilute environmental colloids by flow field-flow fractionation using an opposed flow sample concentration technique. Analytical Chemistry. ,vol. 70, pp. 2495- 2503 ,(1998) , 10.1021/AC9710792
John P. Gabrielson, Mark L. Brader, Allen H. Pekar, Kathrin B. Mathis, Gerhard Winter, John F. Carpenter, Theodore W. Randolph, Quantitation of Aggregate Levels in a Recombinant Humanized Monoclonal Antibody Formulation by Size-Exclusion Chromatography, Asymmetrical Flow Field Flow Fractionation, and Sedimentation Velocity Journal of Pharmaceutical Sciences. ,vol. 96, pp. 268- 279 ,(2007) , 10.1002/JPS.20760
Dukjin Kang, Myeong Hee Moon, Development of Non-Gel-Based Two-Dimensional Separation of Intact Proteins by an On-Line Hyphenation of Capillary Isoelectric Focusing and Hollow Fiber Flow Field-Flow Fractionation Analytical Chemistry. ,vol. 78, pp. 5789- 5798 ,(2006) , 10.1021/AC0606958
J.Calvin Giddings, Two-dimensional field-flow fractionation Journal of Chromatography A. ,vol. 504, pp. 247- 258 ,(1990) , 10.1016/S0021-9673(01)89530-3