Adapting to Biology: Maintaining Container–Closure System Compatibility with the Therapeutic Biologic Revolution

作者: D. Degrazio

DOI: 10.5731/PDAJPST.2015.01032

关键词:

摘要: … An important aspect of this balance is relegated to the overall compatibility of primary, parenteral container–closure systems with therapeutic biologics. A packaging component within a …

参考文章(51)
Daniel L. Norwood, James O. Mullis, Scott J. Pennino, Leachables and extractables handbook : safety evaluation, qualification, and best practices applied to inhalation drug products Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products. pp. 59- 78 ,(2012) , 10.1002/9781118147672.CH5
Alan Earnshaw, Norman Neill Greenwood, Chemistry of the elements ,(1984)
Aimee M. Morris, Murielle A. Watzky, Richard G. Finke, Protein aggregation kinetics, mechanism, and curve-fitting: A review of the literature Biochimica et Biophysica Acta. ,vol. 1794, pp. 375- 397 ,(2009) , 10.1016/J.BBAPAP.2008.10.016
W Wang, EQ Wang, JP Balthasar, Monoclonal Antibody Pharmacokinetics and Pharmacodynamics Clinical Pharmacology & Therapeutics. ,vol. 84, pp. 548- 558 ,(2008) , 10.1038/CLPT.2008.170
Narendra Chirmule, Vibha Jawa, Bernd Meibohm, Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy Aaps Journal. ,vol. 14, pp. 296- 302 ,(2012) , 10.1208/S12248-012-9340-Y
John Philo, Tsutomu Arakawa, Mechanisms of protein aggregation. Current Pharmaceutical Biotechnology. ,vol. 10, pp. 348- 351 ,(2009) , 10.2174/138920109788488932
Nitin Dixit, Kevin M. Maloney, Devendra S. Kalonia, Effect of processing parameters on the physical stability of silicone coatings. Aaps Pharmscitech. ,vol. 13, pp. 1116- 1119 ,(2012) , 10.1208/S12249-012-9843-Y
A. Baumann, Early development of therapeutic biologics--pharmacokinetics. Current Drug Metabolism. ,vol. 7, pp. 15- 21 ,(2006) , 10.2174/138920006774832604