caa a22 4500 445312882 CHVBK 20180317142636.0 cr unu---uuuuu 170323e20110301xx s 000 0 eng 10.1007/s11095-010-0316-2 doi (NATIONALLICENCE)springer-10.1007/s11095-010-0316-2 Accelerated Stability Studies for Moisture-Induced Aggregation of Tetanus Toxoid [Elektronische Daten] [Nishant Jain, Ipsita Roy] ABSTRACT: Purpose: The study was carried out to evaluate the effect of exposing solid tetanus toxoid to moisture in two different ways on the structure and function of the toxoid. Methods: Tetanus toxoid was exposed to moisture by (i) the addition of an optimized amount of buffer and (ii) incubation under an environment provided by a saturated solution of K2CrO4. The changes in the conformational, structural and antigenic properties of tetanus toxoid were measured and compared. Results: Results show that even at a similar level of moisture-induced aggregation, the amounts of water absorbed by the two preparations of tetanus toxoid are different. Differences in antigenicity and changes in structure of the toxoid at primary, secondary and tertiary structure levels were seen. Conclusion: Although both conditions are used to mimic accelerated stability conditions in the laboratory, the final products are different in the two cases. Thus, conditions for ‘accelerated stability studies' for therapeutic proteins need to be selected with care so that they resemble the fate of the actual product. Springer Science+Business Media, LLC, 2010 moisture-induced aggregation nationallicence protein stability nationallicence solid-dose formulation nationallicence tetanus toxoid nationallicence vaccine stability nationallicence Jain Nishant Department of Biotechnology, National Institute of Pharmaceutical Education & Research, 160062, Sector 67, S.A.S. Nagar, Punjab, India aut Roy Ipsita Department of Biotechnology, National Institute of Pharmaceutical Education & Research, 160062, Sector 67, S.A.S. Nagar, Punjab, India aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/3(2011-03-01), 626-639 0724-8741 28:3<626 2011 28 11095 https://doi.org/10.1007/s11095-010-0316-2 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-010-0316-2 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Jain Nishant Department of Biotechnology, National Institute of Pharmaceutical Education & Research, 160062, Sector 67, S.A.S. Nagar, Punjab, India aut NATIONALLICENCE 700 1- Roy Ipsita Department of Biotechnology, National Institute of Pharmaceutical Education & Research, 160062, Sector 67, S.A.S. Nagar, Punjab, India aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/3(2011-03-01), 626-639 0724-8741 28:3<626 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer