# GMP Manufacturing

> **NIH NIH P30** · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · 2024 · $182,829

## Abstract

Abstract Shared Resource 05: GMP Manufacturing (GMP-SR)
The GMP Manufacturing Shared Resource (GMP-SR) at City of Hope (COH) offers both biological and chemical
GMP manufacturing capabilities allowing for rapid and cost-effective translation of novel therapeutic agents to
clinical trials. Together, the biological and chemical GMP facilities are unique to COH and have distinguished it
as one of the premier cancer institutions in the nation for translating innovative therapies developed by COH
investigators over the past decade.
Specific Aims for GMP-SR:
Aim 1. Production of viral vectors.
Aim 2. Production of autologous CAR T cell products, CD34+ HSPC gene therapy, and TIL cell products.
Aim 3. Production of allogeneic cell therapy products for Phase 1 clinical trials.
Aim 4. Manufacturing of small molecule therapeutics.
The GMP-SR consists of two biological facilities, the Center for Biomedicine & Genetics (CBG), the Cell Therapy
Production Center (CTPC), and a Chemical GMP Synthesis Facility (CGSF). These resources provide process
development, project management support, budgeting, regulatory strategy, quality control and quality assurance,
and cGMP-compliant clinical-grade production of immune effector cell products, stem cell-based regenerative
medicine products, monoclonal antibodies, lentivirus, retrovirus, poxvirus, herpes simplex virus, and adenovirus
vectors, vaccines, as well as small molecule agents ranging from low molecular weight molecularly targeted
agents (mw <1000) to complex synthetic biopolymers such as RNA-based oligonucleotide therapeutics and
imaging agents.
The CBG and CTPC are fully cGMP-compliant preclinical and Phase 1/2 pilot manufacturing facilities. In addition
to being multi-product capable, CBG is the nation’s pre-eminent multi-process academic facility capable of
simultaneously producing cGMP-compliant clinical-grade products for preclinical studies and early-stage clinical
trials. These two biological facilities support production of viral vectors and modified cell products in Phase 1
clinical trials. Currently, COH investigators manufacture CAR T cells, CAR Treg cells, NK cells, dendritic cells,
CD34+ hematopoietic stem/progenitor cells, and islet cells. The CGSF manufactures small and large molecule
therapeutics including drugs and biopolymers.
Members Utilization by %Revenue 2017–21: 98.6 Total (1.5 MCBC, 5.8 DCT, 54 CI, 37.3 HM, 0 CCPS)
Publications by Members: 8, 4 with Impact Factor >10
Grants Supported: 6 Total (3 CIRM, 3NCI (2R01))

## Key facts

- **NIH application ID:** 10843151
- **Project number:** 5P30CA033572-41
- **Recipient organization:** BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
- **Principal Investigator:** DAVID HORNE
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $182,829
- **Award type:** 5
- **Project period:** 1997-08-01 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10843151

## Citation

> US National Institutes of Health, RePORTER application 10843151, GMP Manufacturing (5P30CA033572-41). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10843151. Licensed CC0.

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