Stroma-free Hemoglobin & HBOC Production

这份第一阶段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)将携带者(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说 关于管理HBOC安全性和有效性的行动机制。在此阶段，GLP 等级无基质血红蛋白(SFH)将由拥有多年HBOC的团队提纯和交付 在SynZyme的试生产设施中拥有丰富的生产经验。利用我们的HBOC制作团队和 我们的专业知识，在第一阶段合同完成后，将有可能在 第二阶段的后续工作，支持选择HBOC并将其推向商业开发。 与此同时，这些HBOC候选人将支持对各种毒性的系统研究 和机械性问题及其相互关系--这些问题需要在

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