Cellular Processing Core (CPC)The CPC has been established to provide the rapid and safe transition of basic research ideas to clinicalpractice. Some of the preclinical tasks include the qualification and testing of reagents, scale-up of methods,development of Standard Operating Procedures (SOPs), ongoing process validation, the provision of acontrolled good tissue practice GTP infrastructure and support for compiling Investigational New Drug(IND)applications; The CPC will support all 4 Projects in conduct of the clinical trials and will support Project 2 inthe translation of the research studies proposed in this project to develop clinical trials. This is a rate limitingstep at many Institutes and by centralizing this function in the Core, these studies will undergo pre clinicaldevelopment and scale up in an optimal fashion. The personnel in the CPC will assist the PI of Project 2 insubmitting an IND to conduct the clinical trial. The Core will provide all Projects with QA/QC assistance andassist with development of SOPs and worksheets to ensure compliance with regulatory agents in theconduct of the clinical studies.
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