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Characterization of tumor vaccines during product development

机译：产品开发过程中肿瘤疫苗的表征

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The term tumor vaccines encompasses a wide variety of diverse agents capable of interacting with the imune system to product local inflammation. delayed type hypersensitivity reaction and/or tumor regression and, hopefully, a therapeutic effect. These vaccines may be grouped into the following general areas: (1) Cell-based vaccines such as manipulated tumor cells, activated peripheral blood or bone marrow-derived lymphocytes, dendritic cells or other antigen presenting cells (APC) and gene-modified tumor cells or other cells engineered to express cytokines, growth factors or tumor antigens. (2) Antigen preparations, such as synthetic peptides. purified antigens and tumor cell lysates. (3) Viral and plasmid vectors expressing therapeutic genes. (4) Liposome containing antigen, peptides, plasmids encoding tumor antigens. While no tumor vaccine has been licensed by the FDA, numerous clinical trials are ongoing and some products have advanced to Phase III pivotal stages of development. However, as with many novel products, major regulatory and scientific issues associated with clinical use of tumor vaccines remain to be addressed. In this paper, we address issues associated with different types of tumor Vaccines and provide recommendations for the characterization of these vaccines at various stages of development. Published by Elsevier Science Ltd.
机译：术语肿瘤疫苗包括能够与免疫系统相互作用以产生局部炎症的多种多样的试剂。迟发型超敏反应和/或肿瘤消退，并希望有治疗作用。这些疫苗可分为以下一般领域：（1）基于细胞的疫苗，例如操纵的肿瘤细胞，活化的外周血或骨髓来源的淋巴细胞，树突状细胞或其他抗原呈递细胞（APC）和基因修饰的肿瘤细胞或其他工程改造以表达细胞因子，生长因子或肿瘤抗原的细胞。 （2）抗原制剂，例如合成肽。纯化的抗原和肿瘤细胞裂解物。 （3）表达治疗基因的病毒和质粒载体。 （4）含有抗原，肽，编码肿瘤抗原的质粒的脂质体。尽管没有任何一种肿瘤疫苗获得FDA的许可，但正在进行大量的临床试验，并且某些产品已进入III期关键开发阶段。但是，与许多新产品一样，与肿瘤疫苗临床使用相关的主要法规和科学问题仍有待解决。在本文中，我们解决了与不同类型的肿瘤疫苗相关的问题，并为在不同开发阶段表征这些疫苗提供了建议。由Elsevier Science Ltd.发布

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