Translational Cell Therapy Core

University Of Minnesota, Minneapolis MN

Investigators

Linked publications & trials

Abstract

Abstract Our understanding of the biology of stem cells and lymphocytes has increased dramatically, including knowledge about their development, growth requirements and function. Coupled with significant improvements in cell isolation and culture techniques, these advances have created exciting opportunities for clinical translational research using cellular therapy. However, the transition of technology and techniques from a basic research laboratory to a current good manufacture compliant (cGMP) laboratory is complex and nuanced, and neither the basic/translational researcher nor clinician is well versed in the FDA requirements. The main function of Core C is to facilitate the rapid and efficient transfer of basic/translational observations into meaningful and effective cellular therapeutics. Through a series of specific aims, we will describe our process of developing an early stage, laboratory cell population of interest and we will explain how members of Core C will work with investigators to adapt basic laboratory techniques to a cGMP compliant methodology via a pre-cGMP ?staging area?. Members of Core C will provide the necessary documentation in support of FDA IND submissions, including the development of the chemistry, manufacturing and control (CMC) section and related documents. We will describe the production of three cell products (T regulatory cells, memory-like NK cells and T progenitors) which are described in Projects 1 and 3. Core C will also ensure that appropriate quality standards both for the product and facility. Lastly, Core C will interact with project and core investigators, providing cell products for testing as well as advice on cell delivery, dosing and potency assay development as appropriate.