Division of Virology, National Institute for Biological Standards and Control (NIBSC)/Health protection Agency (HPA), Blanche Lane, South Mimms, Hertfordshire, EN6 3QG, UK.
Expert Rev Vaccines. 2012 May;11(5):579-85. doi: 10.1586/erv.12.23.
The specifications of vaccines are determined by the particular product and its method of manufacture, which raise issues unique to the vaccine in question. However, the general principles are shared, including the need to have sufficient active material to immunize a very high proportion of recipients, an acceptable level of safety, which may require specific testing or may come from the production process, and an acceptable low level of contamination with unwanted materials, which may include infectious agents or materials used in production. These principles apply to the earliest smallpox vaccines and the most recent recombinant vaccines, such as those against HPV. Manufacturing development includes more precise definitions of the product through improved tests and tighter control of the process parameters. Good manufacturing practice plays a major role, which is likely to increase in importance in assuring product quality almost independent of end-product specifications.
疫苗的规格由特定产品及其制造方法决定，这就提出了与特定疫苗相关的独特问题。然而，一般原则是相同的，包括需要有足够的活性物质来使极高比例的受种者免疫，具有可接受的安全性水平，这可能需要进行特定的测试，或者来自生产过程，以及可接受的低水平的与不需要的物质的污染，这些物质可能包括传染性病原体或生产过程中使用的材料。这些原则适用于最早的天花疫苗和最近的重组疫苗，如针对 HPV 的疫苗。制造开发包括通过改进测试和更严格地控制工艺参数来更精确地定义产品。良好的生产规范（GMP）起着重要作用，在确保产品质量方面，它的重要性几乎独立于最终产品规格而增加。
