Shared Resource: Therapeutic Manufacturing

Fred Hutchinson Cancer Research Center, Seattle WA

Investigators

Linked publications, trials & patents

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.