# Shared Resource: Therapeutic Manufacturing

> **NIH NIH P30** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2021 · $416,180

## Abstract

PROJECT SUMMARY: THERAPEUTIC MANUFACTURING SHARED RESOURCE (TMSR)
The Fred Hutch/University of Washington Cancer Consortium, a world leader in the detection, diagnosis, and
prevention of cancer, has built a state-of-the-art clinical manufacturing center of excellence within the
Therapeutic Manufacturing Shared Resource (TMSR), located at Fred Hutch (FH). This resource provides
translational services that enable complex cancer research treatments to progress from the lab to the bedside.
TMSR provides clinical manufacturing services for a multitude of products for Consortium investigators that
span from traditional biologics to advanced cell and gene therapy applications. Utilizing the TMSR, Consortium
members have initiated a range of Phase I and II clinical trials that have advanced the scientific understanding
of cancer therapies. The services provided by TMSR follow current Good Manufacturing Practices (cGMP) and
include personnel that are highly trained in the field of clinical manufacturing. Additionally, the facilities and
equipment are maintained in a qualified cGMP manner and all products are subject to quality control testing
and quality assurance systems that ensure the safe manufacture and release of clinical trial materials. The
TMSR also provides project management and process development resources to both improve manufacturing
success rates and help to translate projects from faculty labs into the cGMP manufacturing facility efficiently
and effectively. Taken together, these services are critical for Consortium member who wish to quickly and
safety translate with research directly into the clinic in order to conduct Phase I and II clinical studies in a cost-
effective, compliant, and timely manner for complex cell and gene therapy modalities. The TMSR effectively
consolidates the development and production of highly complex biological and “living” cellular and gene
therapies into a single, shared resource. The TMSR ensures FDA compliance and provides regulatory support
that enables the translation of potential therapeutic products from the benchtop to the bedside thereby
providing direct impact on patient outcomes.

## Key facts

- **NIH application ID:** 10125960
- **Project number:** 5P30CA015704-46
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** James B Adams
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $416,180
- **Award type:** 5
- **Project period:** 1997-01-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10125960

## Citation

> US National Institutes of Health, RePORTER application 10125960, Shared Resource: Therapeutic Manufacturing (5P30CA015704-46). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10125960. Licensed CC0.

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