# Cell &Vector Core

> **NIH NIH P50** · BAYLOR COLLEGE OF MEDICINE · 2021 · $313,795

## Abstract

PROJECT SUMMARY
The four projects comprising this application ultimately involve the use of immune cells to treat lymphoma.
Food and Drug Administration (FDA) regulations require that therapeutic cell populations must be
manufactured under current Good Manufacturing Practices (cGMP). Core C (Cell and Vector Production)
will provide the infrastructure necessary to meet this requirement. The cGMP facility at the Center for Cell
and Gene Therapy consists of 22 ISO 7 clean rooms fully equipped for the preparation of cell and gene
therapy products. For nearly 20 years the staff have manufactured more than 7,000 cellular therapy final
products (and countless intermediates), and >60 clinical grade viral vectors and master and working cell
banks in support of more than 60 IND studies and international clinical protocols. During this period, the
facility was designated as a National Gene Vector Laboratory and as a National Somatic Cell Processing
Facility under a contract from NHLBI Production Assistance for Cellular Therapy (PACT) program.
Manufacturing services are supported by a dedicated specialized flow cytometry laboratory, which performs
>13,000 test annually, a quality control (QC) laboratory performing in-house testing and environmental
monitoring (>25,000 tests/year), and an independent quality assurance (QA) group, which oversees
compliance and provides contract QA services to the NHLBI Cardiovascular Cell Therapy Research
Network (CCTRN). The program is accredited by the Foundation for the Accreditation of Cellular Therapy
(FACT), the College of American Pathologists (CAP), and under the Clinical Laboratory Improvements
Amendments (CLIA). The Cell and Vector Production facility is registered with the FDA and the US
Department of Agriculture. In addition to manufacturing responsibilities, the Core staff are experienced in
transitioning research processes into GMP-compliant procedures and providing regulatory advice. This
experience will be essential in supporting the clinical components of this Lymphoma SPORE application.

## Key facts

- **NIH application ID:** 10247735
- **Project number:** 5P50CA126752-15
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** ADRIAN Philip GEE
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $313,795
- **Award type:** 5
- **Project period:** 2007-04-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247735

## Citation

> US National Institutes of Health, RePORTER application 10247735, Cell &Vector Core (5P50CA126752-15). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10247735. Licensed CC0.

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