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Task C2: Analytical Method, Process Development and Manufacturing for Therapeutics

Task C2: Analytical Method, Process Development and Manufacturing for Therapeutics
任务 C2：治疗药物的分析方法、工艺开发和制造
批准号：
10918695
负责人：
ISABEL SCHOLZ
金额：
$48.53万
依托单位：
NANOTHERAPEUTICS, INC.
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：
已结题
起止时间：
2023-08-28 至 2024-02-27
来源：
https://reporter.nih.gov/project-details/10918695
关键词：
AttenuatedBiological ProductsBiotechnologyDevelopmentDevelopment PlansDocumentationEvaluationFormulationInfluenza TherapeuticMonoclonal AntibodiesNucleic AcidsPeptidesPlasmidsProcessRecombinant ProteinsServicesSmall Interfering RNATestingTherapeuticanalytical methodassay developmentmanufacturepreclinical developmentproduct developmentservice programstherapeutic developmentvector

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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 release testing; process development and formulation; GMP manufacturing; and regulatory CMC documentation support.
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