Cellular Processing Core (CPC) The CPC has been established to provide the rapid and safe transition of basic research ideas to clinical practice. 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 a controlled 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 in the translation of the research studies proposed in this project to develop clinical trials. This is a rate limiting step at many Institutes and by centralizing this function in the Core, these studies will undergo pre clinical development and scale up in an optimal fashion. The personnel in the CPC will assist the PI of Project 2 in submitting an IND to conduct the clinical trial. The Core will provide all Projects with QA/QC assistance and assist with development of SOPs and worksheets to ensure compliance with regulatory agents in the conduct of the clinical studies.
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