# Core C: GMP Cell and Vector Production

> **NIH NIH P50** · BAYLOR COLLEGE OF MEDICINE · 2022 · $280,174

## Abstract

PROJECT SUMMARY
The three projects comprising this application use immune effector 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. Over
the last 23 years, our staff have manufactured more than 7,000 cellular therapy final products (and countless
intermediates), and >70 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 tests annually; a quality control
laboratory performing in-house testing and environmental monitoring (>25,000 tests/year); and an
independent quality assurance group, which oversees compliance. The program is accredited by the
Foundation for the Accreditation of Cellular Therapy, the College of American Pathologists, and under the
Clinical Laboratory Improvements Amendments. The Cell and Vector Production facility is registered with the
FDA. 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:** 10495081
- **Project number:** 2P50CA126752-16
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Natalia Lapteva
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $280,174
- **Award type:** 2
- **Project period:** 2007-09-11 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10495081

## Citation

> US National Institutes of Health, RePORTER application 10495081, Core C: GMP Cell and Vector Production (2P50CA126752-16). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10495081. Licensed CC0.

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