Reprinted with permission from S. Thakral et al. Stabilizers and their interaction with formulation components in frozen and freeze-dried protein formulations. Adv Drug Deliv Rev, 173, 1-19 (2021).
2023
- J. 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).
- J. Sonje, S. Thakral, S. Krueger, R. Suryanarayanan. Enabling Efficient Design of Biological Formulations Through Advanced Characterization. Pharm Res, 40, 1459-1477 (2023).
2022
- J. 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).
- J. 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).
- A. 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, 112(1), 138-147 (2022).
- B. 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).
2021
- J. 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).
- N.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)
- S.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).
- S. 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).
- S.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).
2020
- A.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)
- J. 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).
- J.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).
2019
- S. Jena, N.S. Krishna Kumar, A. Aksan, R. Suryanarayanan. Stability of lyophilized albumin formulations: Role of excipient crystallinity and molecular mobility. Int J Pharm, 569, 118568 (2019).
2018
- S.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).
2017
- S. 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).
2016
- S. Jena, R. Suryanarayanan, A. Aksan. Mutual influence of mannitol and trehalose on crystallization behavior in frozen solutions. Pharm Res, 33(6), 1413-1425 (2016).
2011
- B.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).
- P. 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).