Peetermans J H
SmithKline Biologicals, Rixensart, Belgium.
Postgrad Med J. 1987;63 Suppl 2:97-100.
It is essential that the new generation of recombinant DNA yeast-derived hepatitis B vaccines be prepared according to techniques which are adequately controlled to ensure their safety and efficacy. Various national and supra-national authorities have already issued guidelines for specifications and standardization of such products. Based on these guidelines, the potential hazards, and the state-of-the-art technology, SmithKline Biologicals has developed specifications and analytical methods to cover all aspects of the quality assessment of its recombinant hepatitis B vaccine, Engerix-B. This includes adequate 'in-process' tests to guarantee the optimal reproducibility and standardization of the entire production process as well as methods to study the characteristics and identity of the expressed antigen protein. Finally, specifications and methods of analysis necessary to control the purified bulk product and vaccine in its final container ensure the purity, safety, identity, potency, and stability of each production lot.
新一代重组DNA酵母衍生乙肝疫苗必须按照充分受控的技术制备，以确保其安全性和有效性。各国及超国家当局已发布此类产品的规格和标准化指南。基于这些指南、潜在危害及现有技术，史克必成生物制品公司已制定规格和分析方法，以涵盖其重组乙肝疫苗安在时（Engerix - B）质量评估的各个方面。这包括适当的“过程中”测试，以保证整个生产过程的最佳重现性和标准化，以及研究表达的抗原蛋白特性和同一性的方法。最后，控制纯化半成品和最终容器中疫苗所需的规格和分析方法确保了每个生产批次的纯度、安全性、同一性、效力和稳定性。
