References
- ICH Q11. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), 2012. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf (accessed May 2015).
- Rathore, A.S.; Winkle, H. Quality by Design for Biopharmaceuticals. Nat. Biotechnol. 2009, 27(1), 26–34.
- ICH Q7. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients, 2000. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf (accessed March 2015).
- Kenett, R.; Kenett, D. Quality by Design Applications in Biosimilar Pharmaceutical Products. Accred. Qual. Assur. 2008, 13(12), 681–690.
- Zdanowicz, M.M. Human Growth Hormone: Ethical and Economic Considerations of Use and Misuse. J. Manag. Care Pharm. 1997, 3(4), 448–452.
- EMEA. European Public Assessment Report (EPAR), Omnitrope, EPAR Summary for the Public, 2008; pp. 1–2. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000607/WC500043689.pdf (accessed June 2015).
- European Pharmacopeia 8th Edition. Directore for the Quality of Medicine of the Council of Europe (EDQM), Monographs Q-S. Vol. 2, EDQM: Nördlingen, Germany, 2013.
- USP 38-NF33. United States Pharmacopeial Convention, Somatropin for Injection. Vol. 3, USPC: Rockville, MD, 2015.
- Olins, P.O.; Devine, C.S.; Rangwala, S.H.; Kavka, K.S. The T7 Phage Gene 10 Leader RNA, A Ribosome-binding Site that Dramatically Enhances the Expression of Foreign Genes in Escherichia coli. Gene 1988, 73(1), 227–235.
- Remaut, E.; Stanssens, P.; Fiers, W. Plasmid Vectors for High-efficiency Expression Controlled by the PL Promoter of Coliphage Lambda. Gene 1981, 15(1), 81–93.
- Lowman, H.B.; Bina, M. Temperature-mediated Regulation and Downstream Inducible Selection for Controlling Gene Expression from the Bacteriophage λ pL Promoter. Gene 1990, 96(1), 133–136.
- Patra, A.K.; Mukhopadhyay, R.; Mukhija, R.; Krishnan, A.; Garg, L.C.; Panda, A.K. Optimization of Inclusion Body Solubilization and Renaturation of Recombinant Human Growth Hormone from Escherichia coli. Prot. Exp. Purif. 2000, 18(2), 182–192.
- Karlsson, G.; Gellerfors, P.; Persson, A.; Norén, B.; Edlund, P.O.; Sandberg, C.; Birnbaum, S. Separation of Oxidized and Deamidated Human Growth Hormone Variants by Isocratic Reversed-phase High-performance Liquid Chromatography. J. Chromatogr. A 1999, 855(1), 147–155.
- Nafissi-Varcheh, N.; Shafaati, A.; Zarghi, A.; Aboofazeli, R. Separation of Somatropin and Its Degradation Products by High-performance Liquid Chromatography Using a Reversed-phase Polymeric Column. Iran. J. Pharm. Res. 2004, 3(4), 209–213.
- Storms, S.M.; Feltus, A.; Barker, A.R.; Joly, M.A.; Girard, M. Determination of Somatropin Charged Variants by Capillary Zone Electrophoresis – Optimisation, Verification and Implementation of the European Pharmacopoeia Method. Pharmeur. Sci. Notes 2009, 1, 25–26.
- Kim, M.-J.; Park, H.S.; Seo, K.H.; Yang, H.-J.; Kim, S.-K.; Choi, J.-H. Complete Solubilization and Purification of Recombinant Human Growth Hormone Produced in Escherichia coli. PLoS One 2013, 8(2), e56168.
- Freydell, E.J.; Ottens, M.; Eppink, M.; van Dedem, G.; van der Wielen, L. Efficient Solubilization of Inclusion Bodies. Biotechnol. J. 2007, 2(6), 678–684.
- Teh, L.C.; Murphy, L.J.; Huq, N.L.; Surus, A.S.; Friesen, H.G.; Lazarus, L.; Chapman, G.E. Methionine Oxidation in Human Growth Hormone and Human Chorionic Somatomammotropin. Effects on Receptor Binding and Biological Activities. J. Biol. Chem. 1987, 262(14), 6472–6477.
- Gellerfors, P.; Pavlu, B.; Axelsson, K.; NyhlÉN, C.; Johansson, S. Separation and Identification of Growth Hormone Variants with High Performance Liquid Chromatography Techniques. Acta Paediatr. 1990, 79, 93–100.
- Karlsson, G.; Eriksson, K.; Persson, A.; Månsson, H.; Söderholm, S. The Separation of Recombinant Human Growth Hormone Variants by UHPLC. J. Chromatogr. Sci. 2013, 51(10), 943–949.
- Singh, S.M.; Panda, A.K. Solubilization and Refolding of Bacterial Inclusion Body Proteins. J. Biosci. Bioeng. 2005, 99(4), 303–310.
- Rathore, A.S.; Bade, P.; Joshi, V.; Pathak, M.; Pattanayek, S.K. Refolding of Biotech Therapeutic Proteins Expressed in Bacteria: Review. J. Chem. Technol. Biotechnol. 2013, 88(10), 1794–1806.
- Clark, E.D.B. Protein Refolding for Industrial Processes. Curr. Opin. Biotechnol. 2001, 12(2), 202–207.
- Bayol, A.; Bristow, A.; Charton, E.; Girard, M.; Jongen, P. Somatropin and Its Variants: Structural Characterization and Methods of Analysis. Pharmeur. Bio. 2004, 1, 35–45.
- Wang, W.; Nema, S.; Teagarden, D. Protein Aggregation—Pathways and Influencing Factors. Int. J. Pharm. 2010, 390(2), 89–99.
- Gummadi, S. What is the Role of Thermodynamics on Protein Stability? Biotechnol. Bioprocess. Eng. 2003, 8(1), 9–18.
- Tsumoto, K.; Umetsu, M.; Kumagai, I.; Ejima, D.; Philo, J.S.; Arakawa, T. Role of Arginine in Protein Refolding, Solubilization, and Purification. Biotechnol. Progr. 2004, 20(5), 1301–1308.
- Fazeli, A.; Haji-Abdolvahab, M.; Shojaosadati, S.; Schellekens, H.; Khalifeh, K.; Moosavi-Movahedi, A.; Fazeli, M. Effect of Arginine on Pre-nucleus Stage of Interferon Beta-1b Aggregation. AAPS PharmSciTech 2014, 15(6), 1619–1629.
- Wang, W. Protein Aggregation and Its Inhibition in Biopharmaceutics. Int. J. Pharm. 2005, 289(1–2), 1–30.
- Flores-Ortiz, L.; Campos-García, V.; Perdomo-Abúndez, F.; Pérez, N.; Medina-Rivero, E. Physicochemical Properties of Rituximab. J. Liquid Chromatogr. Relat. Technol. 2014, 37(109), 1438–1452.