Hsieh C L
Wyeth-Lederle Vaccines, Sanford, North Carolina 27330, USA.
Dev Biol (Basel). 2000;103:93-104.
A seven-valent pneumococcal conjugate and a Group C Meningococcal conjugate are at the late stage of development. Clinical studies have demonstrated the efficacy and safety of these vaccines and licensure of these vaccines will be approved in the near future. Several new techniques have been proposed for characterizing polysaccharide-protein conjugates and their production intermediates. We are evaluating some of these new techniques, particularly NMR and MALLS, to determine whether or not they provide useful information for conjugate production. In the production of polysaccharide protein conjugates, the degree of saccharide activation, location of activation site, and the molecular weight of activated saccharides may typically be determined. In our evaluation, techniques such as NMR and MALLS may have a limited applicability for testing polysaccharides and activated saccharides.
一种七价肺炎球菌结合疫苗和一种C群脑膜炎球菌结合疫苗正处于开发后期。临床研究已证明这些疫苗的有效性和安全性，且这些疫苗将在不久后获得批准。已经提出了几种用于表征多糖-蛋白质结合物及其生产中间体的新技术。我们正在评估其中一些新技术，特别是核磁共振（NMR）和多角度激光光散射（MALLS），以确定它们是否能为结合物生产提供有用信息。在多糖-蛋白质结合物的生产中，通常可以确定糖激活的程度、激活位点的位置以及活化糖的分子量。在我们的评估中，诸如NMR和MALLS等技术在测试多糖和活化糖方面的适用性可能有限。
