Specifications and quality control of a yeast-derived hepatitis B vaccine.

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.