# Core B: GMP Cell and RNA Manufacturing

> **NIH NIH P01** · UNIVERSITY OF PENNSYLVANIA · 2021 · $235,793

## Abstract

SUMMARY CORE B: GMP CELL and RNA MANUFACTURING 
Core B is the Clinical Cell and Vaccine Production Facility (CVPF). The CVPF is a Foundation for the 
Accreditation of Cellular Therapy (FACT)-accredited, Good Manufacturing Practices (GMP) compliant cell and 
RNA manufacturing facility. This facility supports “bench to bedside” translation of innovative investigational 
cell and gene biologics for a wide range of cancers, infectious diseases, and other therapeutic indications at 
the University of Pennsylvania (Penn) and its collaborating institutions. The CVPF supports manufacturing for 
18 investigational new drug applications (INDs), and has produced over 2400 cellular vaccines that have been 
safely administered to more than 900 patients. The CVPF is designated as the Core B GMP cell and RNA 
manufacturing resource for the projects outlined in this proposal, and supports a) process development and 
validation experiments for successful GMP clinical translation of cell and RNA manufacturing and b) clinical 
trial manufacturing and final product testing of gene modified cells for human administration. The CVPF will 
provide specific support for the proposed projects through the development of protocols to manufacture (1) 
tandem CD19 CAR T cell and CD22 CAR T cell products, (2) TCR negative, HLA-I negative CD19 CAR T 
cells, (3) CD33 negative hematopoietic stem cells and CD33 CAR T cells, and (4) tandem CD19 CAR T cell 
and BCMA CAR T cell products. To achieve effective deletion of the above mentioned targets (TCR, HLA-I, 
CD33) we will manufacture GMP-grade guide RNAs and Cas9 mRNA. We will electroporate therapeutic cells 
with these RNA constructs to create CRISPR/Cas9 mediate, target negative cells. Quality control assays and 
release criteria will be developed for each therapeutic cell type to ensure consistent production of safe and 
high quality modified cells.

## Key facts

- **NIH application ID:** 10245069
- **Project number:** 5P01CA214278-05
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** DONALD Lawrence SIEGEL
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $235,793
- **Award type:** 5
- **Project period:** 2017-08-15 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10245069

## Citation

> US National Institutes of Health, RePORTER application 10245069, Core B: GMP Cell and RNA Manufacturing (5P01CA214278-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10245069. Licensed CC0.

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