# GMP Manufacturing Core

> **NIH NIH P30** · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · 2020 · $180,663

## Abstract

GMP Manufacturing Core Shared Resource 
ABSTRACT 
The GMP Manufacturing Core Facility at City of Hope offers both biological and chemical GMP manufacturing 
capabilities. The biological facilities consist of the Biologics & Cellular GMP Manufacturing Center, comprising 
the Center for Biomedicine and Genetics (CBG) and the Cell Therapy Production Center (CTPC). The Chemical 
GMP Synthesis Facility (CGSF) is a stand-alone operation providing state-of-the-art biopolymer and small 
molecule manufacturing. COH is the only Cancer Center in the US to provide both biological and chemical GMP 
manufacturing at a single institution. These facilities provide process development, regulatory support, and 
cGMP-compliant clinical-grade production of CAR T cell products, stem cell-based regenerative medicine 
products, monoclonal antibodies, lentiviral vectors, vaccines, and complex molecules including, biopolymers 
(peptides, siRNA-aptamers, DNA-peptide hybrids), nanomaterials, and natural products. 
Opened in 2000, the CBG is a fully cGMP-compliant 20,000 square foot preclinical and Phase I/II pilot 
manufacturing facility with 10,000 square feet of classified production space. In addition to being multi-product 
capable, it is the nation’s pre-eminent multi-process academic facility capable of simultaneously producing 
cGMP-compliant clinical-grade products in sufficient quantities for preclinical studies and early stage clinical 
trials. The CBG supports COH investigators in the production of viral vectors and modified cell products (CAR T 
cells; gene-modified CD34+ cells; gene-modified neural stem cells) that are currently in Phase I clinical trials for 
indications including CD19+ malignancies, AML, GBM, and AIDs-related lymphoma. The CTPC is also 
cGMP-compliant and opened in 2010 to meet additional demand for cell therapeutics. The CTPC provides 6,800 
sq. ft. of production space and is capable of simultaneous multi-product and multi-process manufacturing. The 
state-of-the-art CGSF (established in 2012) manufactures small and large molecule therapeutics. It also 
produces nanomaterials, complex natural products, and biopolymers, such as peptides, siRNA-aptamers, DNA- 
peptide hybrids. The CGSF provides services including: drug discovery, process research, development, and 
early clinical manufacturing of pharmaceutical drug substances (APIs). The facility is designed with three 
independent manufacturing suites to produce API that meets Food and Drug Administration requirements and 
on sufficient scales (gram to kilogram) for preclinical toxicology studies and Phase I/II clinical trials. 
The GMP Manufacturing Core is co-directed by Joseph Gold, PhD, David Horne, PhD, and Dr. David Hsu. Over 
the past five years, the Core was used by a total of 28 unique investigators, including ten CC members and eight 
NCI-designated Cancer Centers. In addition, 553 products were manufactured and 7 separate cancer clinical 
trials were supported by the Core.

## Key facts

- **NIH application ID:** 9849203
- **Project number:** 5P30CA033572-37
- **Recipient organization:** BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
- **Principal Investigator:** Behnam Badie
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $180,663
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9849203

## Citation

> US National Institutes of Health, RePORTER application 9849203, GMP Manufacturing Core (5P30CA033572-37). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9849203. Licensed CC0.

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