Gene Transfer and Somatic Cell Enginerring

NIH RePORTER · NIH · P30 · $383,196 · view on reporter.nih.gov ↗

Abstract

ABSTRACT 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).

Key facts

NIH application ID
9858285
Project number
5P30CA008748-54
Recipient
SLOAN-KETTERING INST CAN RESEARCH
Principal Investigator
Isabelle Riviere
Activity code
P30
Funding institute
NIH
Fiscal year
2020
Award amount
$383,196
Award type
5
Project period
— → —