Analytical strategy for biopharmaceutical development

Process Scale Bioseparations for the Biopharmaceutical Industry

Volumn , Issue , 2006, Pages 395-418

  Kelner, Drew N ^a   Bhalgat, Mahesh K ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85123401228     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (18)

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5. American Society for Testing and Materials (ASTM), Draft Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products. Developed under ASTM Subcommittee E-48.01 (Materials for Biotechnology), Task Group.05 (R. L. Gamick, Chairman), Philadelphia, PA, February (1988).
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12. Viral safety. Chapter 14 of this volume.
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14. http://www.fda.gov/cder/OPS/PAT.htm.
15. Lewis EN, Schoppelri J, and Lee E. Molecular spectroscopy workbench - Near-infrared chemical imaging and the PAT initiative. Spectroscopy, 2004;19(4):26-36.
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18. Food and Drug Adminstration [Docket No. 2004N-0355] Scientific Considerations Related to Developing Biotechnology Products. August 2004 (weblink:http://www.fda.gov/ohrms/dockets/dockets/04n0355/04N-0355-EC-9-Attach-1.pdf).