The mission of the Gene Transfer and Somatic Cell Engineering (GTSC) Core is to develop, validate, and supply cell-based experimental products for Phase I and II clinical trials so that investigators can evaluate their safety and potential clinical benefit. In 2014, the GTSC Core moved to the Cell Therapy and Cell Engineering Facility (CTCEF), which opened when the Zuckerman II building was opened.
The aims of the GTSC Core have not changed. The Core supports the implementation of Phase I/II clinical trials based on cell engineering and adoptive cell therapies.
Its aims are as follows:
AIM1 : To develop SOPs and batch records for cell processing and engineering, vector production.
AIM2 : GMP manufacturing: Patient cell (expansion, purification, transduction, formulation); Vector stocks (plasmid DNA, cell banks).
AIM3 : Biosafety/release testing: Patient cells and vector stocks (e.g., phenotype, potency, purity, stability); Gene transfer/expression.
AIM4 : To monitor patients? samples post-infusion (e.g., FACS, Q-PCR).
AIM5 : To provide technological and regulatory expertise (GXP, FDA, RAC-NIH).
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