多肽疫苗生产及质控技术指导原则(英文).docxVIP

多肽疫苗生产及质控技术指导原则前言（略）Preface (Omission)多肽疫苗的化学合成（略）The chemical synthesis of?peptide vaccines (Omission)多肽疫苗的生产工艺及质控Studies onpolypeptide vaccine product process and quality control应提供研制某一疫苗的详细资料，包括选择特定抗原决定簇的理由、对抗原决定簇的检定，以及对载体、表位连接、结合剂、肽的呈递方式及佐剂等的选择理由及其相应证据。The Details of vaccine including reasons for selecting specific antigenic determinate, tests of epitopes, as well as carriers, epitope conjugation, binding agents, peptide-presenting methods and adjuvants. 应说明每条肽段所针对的抗原表位。内容包括对每个表位来源的说明，当不止一个表位时，应说明把不同表位相互结合到一个已知序列内的理由，此外还应对表位的类型（B、Th、Tc等）及特殊组合方式进行说明。Indicate each peptide against epitope, including the descriptions of the source of each epitope, reasons for combinin the different epitopes to known sequences if more than one epitope. The type of epitope (for example, B, Th, Tc, etc.) and and the particular combination will be described.应当提供肽链合成的详细资料。内容包括：原料的来源和特性、使用的方法学、氨基酸的连接和脱保护，进入下一步连接的判断标准，任何加入的修饰基团（例如糖基化，脂质化）的详细情况。如果采用了液体合成法，应当提供包括对中间体有特殊说明的流程图。the details of the peptide synthesis, including the sources and characteristics of materials, methodology, the connection and deprotection of amino acids, the criterias for determining the next conjugation, each modifier groups (for example, glycosylation, lipidation). The liquid synthetic method should provided flowchart with special instructions including intermediate.如果肽单体为中间产物，应当对其分离鉴定并提供下述确证依据。If the peptide monomer is an intermediate product, it should be isolated and identified and provide the confirmation basis as the below:?主要肽顺序与预期的结构相同，例如，目标氨基酸按需要的顺序排列；修饰（脂化及糖基化）情况；Major peptide sequence is identical with the expected structure, for example, the target amino acids are in the?correct?sequence as designed, modification condition (lipidation and glycosylation).对肽单体中的主要杂质（可能情况下对次要杂质）应分离鉴定。Main impurities in Peptide monomers (possible minor impurities) isolation and identification.??连续多批产品的肽质量应保持一致。The production of peptide shall consistently have been shown the same quality.对肽单体或肽衍生物应建立适当的标准。对肽的纯度、总杂质、每种主要及次要杂质都应