Stroma-free Hemoglobin & HBOC Production

无基质血红蛋白

• 批准号: 7681422
• 金额: $ 10万
• 依托单位: SYNZYME TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7681422
• 关键词: Stroma; free; Hemoglobin; HBOC; Production

This Phase I SBIR contract proposal supports the NIH quest to bring hemoglobin-based oxygen carriers (HBOCs) to market by providing GMP grade generic hemoglobin (Hb) to researchers working to address the toxicity issues of previous clinical trials and evaluate newly emerging hypotheses regarding mechanisms of action governing the safety and effcacy of HBOC. In this Phase I, GLP grade stroma-free hemoglobin (SFH) will be purified and delivered by a team with years of HBOC production experience at SynZyme's pilot production facility. Utilizing our HBOC production team and our expertise, it will be feasible, after completion of this Phase i contract, to provide generic HBOCs in a follow-on Phase Ii to support selection and advancement of HBOC's into commercial development. In the meantime, these HBOC candidates will support the systematic studies of the various toxicity and mechanistic issues and their inter-relationships - issues which need to be resolved before

这一第一阶段 SBIR 合同提案支持 NIH 寻求带来基于血红蛋白的氧气 通过向研究人员提供 GMP 级通用血红蛋白 (Hb)，将载体 (HBOC) 推向市场 解决先前临床试验的毒性问题并评估新出现的假设 关于控制 HBOC 安全性和有效性的行动机制。在第一阶段，GLP 级无基质血红蛋白 (SFH) 将由具有多年 HBOC 经验的团队纯化和提供 SynZyme 中试生产设施的生产经验。利用我们的 HBOC 制作团队和 根据我们的专业知识，在第一阶段合同完成后，在以下地区提供通用 HBOC 将是可行的： 后续第二阶段将支持 HBOC 的选择和推进进入商业开发。 同时，这些HBOC候选者将支持各种毒性的系统研究 和机制问题及其相互关系——之前需要解决的问题