Department of Biotechnology, National Institute of Pharmaceutical Education & Research, Sector 67, SAS Nagar, Punjab 160062, India.
Pharm Res. 2011 Mar;28(3):626-39. doi: 10.1007/s11095-010-0316-2. Epub 2010 Nov 12.
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.
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 K(2)CrO(4.) The changes in the conformational, structural and antigenic properties of tetanus toxoid were measured and compared.
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.
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.
本研究旨在评估破伤风类毒素暴露于两种不同水分条件下对类毒素结构和功能的影响。
通过（i）添加优化量的缓冲液和（ii）在饱和重铬酸钾溶液提供的环境中孵育，使破伤风类毒素暴露于水分中。测量并比较了破伤风类毒素的构象、结构和抗原性的变化。
结果表明，即使在类似的水分诱导聚集水平下，两种破伤风类毒素制剂所吸收的水量也不同。在一级、二级和三级结构水平上，类毒素的抗原性和结构变化存在差异。
尽管这两种条件都用于模拟实验室中的加速稳定性条件，但两种情况下的最终产物是不同的。因此，对于治疗性蛋白的“加速稳定性研究”条件需要谨慎选择，以便它们类似于实际产品的命运。
