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 Projects 1 and 3 in the translation of the research studies proposed in these projects to 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 PIs of Projects 1 and 3 in submitting an IND to conduct the clinical trials, will provide QA/QC assistance and will generate SOPs and worksheets to ensure compliance with regulatory agents in the conduct of the clinical studies.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
5U54HL081028-02
Application #
7312650
Study Section
Special Emphasis Panel (ZHL1)
Project Start
Project End
Budget Start
2006-09-01
Budget End
2007-08-31
Support Year
2
Fiscal Year
2006
Total Cost
$300,781
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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