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PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT DEVELOPMENT

PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT DEVELOPMENT
生物制药产品开发的临床前服务
批准号：
10903687
负责人：
PHILLIP ISHIKAWA
金额：
$0.07万
依托单位：
ADVANCED BIOSCIENCE LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
项目状态：
已结题
起止时间：
2016-09-01 至 2017-08-31
来源：
https://reporter.nih.gov/project-details/10903687
关键词：
AttenuatedBiological ProductsBiotechnologyDevelopmentDevelopment PlansDocumentationEvaluationFormulationInfectious Diseases ResearchMonoclonal AntibodiesNucleic AcidsPeptidesPlasmidsProcessRecombinant ProteinsServicesSmall Interfering RNATranslational Researchassay developmentmanufacturepre-clinicalpreclinical developmentproduct developmentservice programsvector

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中文摘要
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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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