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Preclinical Services for Antibacterial Resistance Biopharmaceutical Product Development

Preclinical Services for Antibacterial Resistance Biopharmaceutical Product Development
抗菌药物耐药性生物制药产品开发的临床前服务
批准号:
10934774
负责人:
金额:
$0.26万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-09-08 至 2030-09-07

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中文摘要
翻译
生物制药产品开发服务项目提供服务,以促进来自生物技术过程的材料的临床前开发,如单克隆抗体和单克隆抗体的衍生物;重组蛋白;肽;核酸载体(siRNA、质粒);以及活的,被修改的活的和/或弱化的实体。服务内容包括:产品开发策划与评估;试验开发和产品表征;工艺开发和制定;GMP制造;监管CMC文件支持。其目的是推进传染病的转化研究。
英文摘要
The Biopharmaceutical Product Development Services program provides services to facilitate preclinical development of materials that are derived from biotechnology processes, such as monoclonal antibodies and derivatives of monoclonal antibodies; recombinant proteins; peptides; nucleic acid based vectors (siRNA, plasmids); and live, modified-live and/or attenuated entities. Services include: product development planning and evaluation; assay development and product characterization; process development and formulation; GMP manufacturing; and regulatory CMC documentation support. The aim is advance translational research for infectious diseases.
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