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Technical product attributes in development of an oral enteric vaccine for infants

机译:婴幼儿口腔肠道疫苗开发的技术产品属性

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Development of an oral enteric vaccine for infants is important for Shigella and enterotoxigenic Escherichia coli (ETEC) vaccine development. At a recent workshop titled "Technical Product Attributes in Development of an Oral Enteric Vaccine for Infants,” at the 2nd International Vaccines Against Shigella and ETEC Conference (VASE Conference), the preferred product attributes for development were discussed for these vaccines. The aims of this workshop were to identify gaps and gather opinions from key experts from preclinical, process development, manufacturing, regulatory, and clinical areas to fine-tune and refine key target product attributes for infant oral vaccine development. The workshop used some examples of marketed oral infant vaccines todiscuss potential improvements that can be made, such as inclusion of preservatives, multidose vials, and antacid buffer presentation (liquid or lyophilized) in novel oral enteric vaccine development.
机译:婴儿口腔肠道疫苗的开发对于志贺氏菌和肠毒素大肠杆菌(ETEC)疫苗发育很重要。 在最近的题为“婴儿口头肠道疫苗的技术产权的技术产权”的研讨会上,在对阵志贺卡和ETEC会议(花瓶会议)的第二件国际疫苗中,对这些疫苗进行了讨论了开发的首选产品属性。目的 本讲习班是识别差距,从临床前,工艺开发,制造,监管和临床区域收集关键专家的意见,以进行微调和细化婴儿口腔疫苗开发的关键目标产品属性。研讨会使用了一些营销口头婴儿的例子 疫苗汤姆斯潜在的改进,例如包含防腐剂,多糖瓶和抗酸缓冲液(液体或冻干)在新型口腔肠疫苗发育中。

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