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Development of biotechnology products in pre-filled syringes: technical considerations and approaches.
Badkar A, Wolf A, Bohack L, Kolhe P. Badkar A, et al. Among authors: kolhe p. AAPS PharmSciTech. 2011 Jun;12(2):564-72. doi: 10.1208/s12249-011-9617-y. Epub 2011 May 4. AAPS PharmSciTech. 2011. PMID: 21538214 Free PMC article.
Protein and solute distribution in drug substance containers during frozen storage and post-thawing: a tool to understand and define freezing-thawing parameters in biotechnology process development.
Kolhe P, Badkar A. Kolhe P, et al. Biotechnol Prog. 2011 Mar-Apr;27(2):494-504. doi: 10.1002/btpr.530. Epub 2011 Feb 7. Biotechnol Prog. 2011. PMID: 21302371
Frozen state storage instability of a monoclonal antibody: aggregation as a consequence of trehalose crystallization and protein unfolding.
Singh SK, Kolhe P, Mehta AP, Chico SC, Lary AL, Huang M. Singh SK, et al. Among authors: kolhe p. Pharm Res. 2011 Apr;28(4):873-85. doi: 10.1007/s11095-010-0343-z. Epub 2011 Jan 7. Pharm Res. 2011. PMID: 21213025
Impact of freezing on pH of buffered solutions and consequences for monoclonal antibody aggregation.
Kolhe P, Amend E, Singh SK. Kolhe P, et al. Biotechnol Prog. 2010 May-Jun;26(3):727-33. doi: 10.1002/btpr.377. Biotechnol Prog. 2010. PMID: 20039442
Comparative evaluation of disodium edetate and diethylenetriaminepentaacetic acid as iron chelators to prevent metal-catalyzed destabilization of a therapeutic monoclonal antibody.
Zhou S, Zhang B, Sturm E, Teagarden DL, Schöneich C, Kolhe P, Lewis LM, Muralidhara BK, Singh SK. Zhou S, et al. Among authors: kolhe p. J Pharm Sci. 2010 Oct;99(10):4239-50. doi: 10.1002/jps.22141. J Pharm Sci. 2010. PMID: 20737631
Ex Situ and In Situ Characterization of Vaccine Suspensions in Pre-Filled Syringes.
Lewis LM, Guo J, Torres E, Wang J, Billones H, Kolhe P, Young AL, Bates D, Parker A, Rigby-Singleton S. Lewis LM, et al. Among authors: kolhe p. J Pharm Sci. 2017 Aug;106(8):2163-2167. doi: 10.1016/j.xphs.2017.04.055. Epub 2017 Apr 30. J Pharm Sci. 2017. PMID: 28465152
The Effect of Shipping Stresses on Vaccine Re-dispersion Time.
Guo J, Lewis LM, Billones H, Torres E, Kolhe P. Guo J, et al. Among authors: kolhe p. J Pharm Sci. 2016 Jun;105(6):2009-2013. doi: 10.1016/j.xphs.2016.03.023. Epub 2016 May 5. J Pharm Sci. 2016. PMID: 27155766
Contribution of Intravenous Administration Components to Subvisible and Submicron Particles Present in Administered Drug Product.
Pollo M, Mehta A, Torres K, Thorne D, Zimmermann D, Kolhe P. Pollo M, et al. Among authors: kolhe p. J Pharm Sci. 2019 Jul;108(7):2406-2414. doi: 10.1016/j.xphs.2019.02.020. Epub 2019 Mar 5. J Pharm Sci. 2019. PMID: 30849460
Molecular attributes of conjugate antigen influence function of antibodies induced by anti-nicotine vaccine in mice and non-human primates.
McCluskie MJ, Thorn J, Mehelic PR, Kolhe P, Bhattacharya K, Finneman JI, Stead DR, Piatchek MB, Zhang N, Chikh G, Cartier J, Evans DM, Merson JR, Davis HL. McCluskie MJ, et al. Among authors: kolhe p. Int Immunopharmacol. 2015 Apr;25(2):518-27. doi: 10.1016/j.intimp.2015.02.030. Epub 2015 Feb 28. Int Immunopharmacol. 2015. PMID: 25737198
Hyperbranched polymer-drug conjugates with high drug payload for enhanced cellular delivery.
Kolhe P, Khandare J, Pillai O, Kannan S, Lieh-Lai M, Kannan R. Kolhe P, et al. Pharm Res. 2004 Dec;21(12):2185-95. doi: 10.1007/s11095-004-7670-x. Pharm Res. 2004. PMID: 15648249
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