Reprinted from Thakral, Seema, et al. "Stabilizers and their interaction with formulation components in frozen and freeze-dried protein formulations." Advanced Drug Delivery Reviews Vol. 173 (2021). Copyright (2021), with permission from Elsevier Citation YearCitation2023J. Li, J. Sonje, R. Suryanarayanan. Role of Poloxamer 188 in preventing ice-surface-induced protein destabilization during freeze–thawing. Mol. Pharm, 20: 4587-4596 (2023).2023J. Sonje, S. Thakral, S. Krueger, R. Suryanarayanan. Enabling Efficient Design of Biological Formulations Through Advanced Characterization. Pharm Res, 40: 1459-1477 (2023).2022J. Sonje, S. Thakral, B. Mayhugh, G. Sacha, S. Nail, J. Srinivasan, R. Suryanarayanan, Mannitol hemihydrate in lyophilized protein formulations: Impact of its dehydration during storage on sucrose crystallinity and protein stability. Int J Pharm, 624: 121974 (2022).2022J. Sonje, C.F. Chisholm, R. Suryanarayanan, Frozen storage of proteins: Use of mannitol to generate a homogenous freeze-concentrate. Int J Pharm, 630: 121995 (2022).2022A. Ukidve, K.B. Rembert, R. Vanipenta, P. Dorion, P. Lafarguette, T. McCoy, A. Saluja, R. Suryanarayanan, S. Patke, Succinate buffer in biologics products: Real-world formulation considerations, processing risks and mitigation strategies. J Pharm Sci, In Press, Corrected Proof (2022).2022B. Munjal, S.M. Patel, R. Suryanarayanan, Role of arginine salts in preventing freezing-induced increase in subvisible particles in protein formulations. Int J Pharm, 619: 121694 (2022).2021J. Sonje, S. Thakral, S. Krueger, R. Suryanarayanan, Reversible self-association in lactate dehydrogenase during freeze-thaw in buffered solutions using neutron scattering. Mol Pharm, 18(12), 4459-4474 (2021).2021N.K. Duggirala, J. Sonje, X. Yuan, E. Shalaev, R. Suryanarayanan, Phase behavior of Poloxamer 188 in frozen aqueous solutions – Influence of processing conditions and cosolutes. Int J Pharm, 609,121145 (2021)2021S.S. Kulkarni, S.M. Patel, R. Suryanarayanan, J.V. Rinella, Jr., R.H. Bogner, Key factors governing the reconstitution time of high concentration lyophilized protein formulations. Eur J Pharm Biopharm, 165: 361-373 (2021).2021S. Thakral, J. Sonje, B. Munjal, R. Suryanarayanan, Stabilizers and their interaction with formulation components in frozen and freeze-dried protein formulations. Adv Drug Deliv Rev, 173: 1-19 (2021).2021S.S. Kulkarni, S.M. Patel, R. Suryanarayanan, J.V. Rinella Jr., R.H. Bogner, Key factors governing the reconstitution time of high concentration lyophilized protein formulations. Eur J Pharm Biopharm, 165: 361-373 (2021).2020A.A. Thorat, B. Munjal, T.W. Geders, R. Suryanarayanan, Freezing-induced protein aggregation – Role of pH shift and potential mitigation strategies, J Control Release, 323, 591-599 (2020)2020J. Sonje, S. Thakral, R. Suryanarayanan, t-Butanol enables dual functionality of mannitol: A cryoprotectant in frozen systems and bulking agent in freeze-dried formulations. Mol Pharm, 17(8), 3075-3086 (2020).2020J.R. Snell, N.K. Kumar, R. Suryanarayanan, T.W. Randolph, Nanobubbles in reconstituted lyophilized formulations: Interaction with proteins and mechanism of formation. J Pharm Sci, 109(1):284-292 (2020).2019S. Jena, N.S.K. Kumar, A. Aksan, R. Suryanarayanan, Stability of lyophilized albumin formulations: Role of excipient crystallinity and molecular mobility. Int J Pharm, 569:118568 (2019).2018S.S. Kulkarni, R. Suryanarayanan, J.V. Rinella Jr., R.H. Bogner, Mechanisms by which crystalline mannitol improves the reconstitution time of high concentration lyophilized protein formulations. Eur J Biopharm, 130: 70-81 (2018).2017S. Jena, J. Horn, R. Suryanarayanan, W. Friess, A. Aksan, Effects of excipient interactions on the state of the freeze-concentrate and protein stability. Pharm Res, 34(4), 462-478 (2017).2016S. Jena, R. Suryanarayanan, A. Aksan, Mutual influence of mannitol and trehalose on crystallization behavior in frozen solutions. Pharm Res, 33(6), 1413-1425 (2016)2011B.S. Bhatnagar, S.W.H. Martin, T.S. Hodge, T.K. Das, L. Joseph, D.L. Teagarden, E.Y. Shalaev, R. Suryanarayanan, Investigation of PEG crystallization in frozen and freeze-dried PEGylated recombinant human growth hormone-sucrose systems - Implications on storage stability. J Pharm Sci, 100(8), 3062-3075 (2011).2011P. Sundaramurthi, R. Suryanarayanan, Effect of crystallizing and non-crystallizing cosolutes on succinate buffer crystallization and the consequent pH shift in frozen solutions. Pharm Res, 28 (2), 374-385 (2011).Previous publications can be found on Professor Sury's Google Scholar page at this link.
