CORE--MANUFACTURING

核心——制造

• 批准号: 6235397
• 负责人: JERRY VOLENEC
• 金额: $ 20.23万
• 依托单位: CYTEL CORPORATION
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-01 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6235397
• 关键词: AIDS therapy; AIDS vaccines; biomedical facility; cooperative study; cytotoxic T lymphocyte; drug design /synthesis /production; drug quality /standard; human immunodeficiency virus 1; peptide chemical synthesis; synthetic peptide; vaccine development

Core B, the manufacturing core will develop, manufacture, Quality Control test and release of novel, peptide-based immunotherapeutic vaccines for stimulation of Cytotoxic T Lymphocyte (CTL) immunity in humans in AIDS treatment research. The specific aims for this project are: 1) To contract the manufacture of purified peptides as defined in the research project in compliance with Good Manufacturing Practices (cGMPs); 2) To develop formulations of the peptides as required for the intended clinical studies as a sterile injectable; 3) To develop the analytical- methods and Quality Control specifications necessary for the comprehensive evaluation and disposition of manufactured drug products; 4) To develop the processes necessary manufacture the raw material peptides into final vial product in the defined formulations; 5) To conduct preclinical toxicologic evaluations of the final dosage forms to assure ifs safety prior to clinical evaluations; 6) To contract with an established fill/finish facility for the GMP vialing of the final vial product; 7) To file the requisite submissions with the FDA for evaluation and gain clearance for release of clinical supplies for clinical investigation; and 8) To conduct stability studies of manufactured drug product to assure that the product tested in the clinical studies continues to meet its release criteria throughout its period of use. Investigational New Drug (IND) and supporting submissions will be made to the FDA. All manufacture will be conducted in compliance with FDA regulations Good Manufacturing Practices (cGMPs).

核心B，制造核心将开发，制造，质量控制 测试和释放基于肽的新型免疫治疗疫苗的测试和释放 AIDS中人类的细胞毒性T淋巴细胞（CTL）免疫的刺激 治疗研究。该项目的具体目的是：1） 收缩研究中定义的纯化肽的生产 符合良好制造实践（CGMP）的项目； 2）到 根据预期的需要开发肽的配方 临床研究是无菌注射的； 3）开发分析 方法和质量控制规格 制成品产品的全面评估和处置； 4）开发必要的过程制造原材料 在定义的制剂中，肽成最终的小瓶产物； 5）到 对最终剂型进行临床前毒理学评估 在临床评估之前确保安全； 6）与 最终小瓶GMP瓶的填充/完成设施 产品; 7）向FDA提交必要的提交以进行评估 并获得释放临床供应的许可 调查; 8）进行制造药的稳定研究 确保产品在临床研究中测试的产品 在整个使用期间，继续符合其发布标准。 将提出调查新药（IND）和支持提交 到FDA。所有制造将符合FDA进行 法规良好的制造实践（CGMP）。