Duru Chinwe, Swann Carolyn, Dunleavy Una, Mulloy Barbara, Matejtschuk Paul
Standardisation Science, NIBSC, Medicines & Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, EN6 3QG, UK.
Laboratory of Molecular Structure, NIBSC, Medicines & Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, EN6 3QG, UK.
Biologicals. 2015 Mar;43(2):110-6. doi: 10.1016/j.biologicals.2014.12.001. Epub 2015 Jan 20.
Lyophilized Influenza antigen reference reagents are a critical resource in the quality control of influenza vaccines. A standard formulation has been used successfully at NIBSC for many years however, following the unexpected occurrence of a collapsed appearance in a particular batch a study was carried out to establish the impact of the sugar concentration in the formulation using modulated differential scanning calorimetry (mDSC) and nuclear magnetic resonance spectroscopy (NMR). There was a correlation between the presence and size of the mDSC eutectic temperature events and the freeze dried appearance of the cakes, which became progressively worse with increasing amounts of sugar. NMR spectroscopy could be used to positively identify and quantify the sugars in the formulations. MDSC can rapidly predict if the freeze dried appearance will be acceptable so as to assure the successful lyophilization of influenza reference preparations.
冻干流感抗原参考试剂是流感疫苗质量控制中的关键资源。多年来，一种标准配方已在NIBSC成功使用。然而，在某一批次中意外出现塌陷外观后，开展了一项研究，使用调制差示扫描量热法（mDSC）和核磁共振光谱法（NMR）来确定配方中糖浓度的影响。mDSC共晶温度事件的存在和大小与冻干饼的外观之间存在相关性，随着糖含量的增加，外观逐渐变差。核磁共振光谱法可用于准确鉴定和定量配方中的糖。MDSC可以快速预测冻干外观是否可接受，以确保流感参考制剂冻干成功。
