Therapeutic Manufacturing Shared Resource

Fred Hutchinson Cancer Center, Seattle WA

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY: THERAPEUTIC MANUFACTURING SHARED RESOURCE The Therapeutic Manufacturing Shared Resource (TMSR) of the Fred Hutchinson/University of Washington/Seattle Children’s Cancer Consortium is located at Fred Hutch and has two current Good Manufacturing Practices (cGMP) Phase I/II clinical product clean room manufacturing facilities. 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. The FACT- (Foundation for the Accreditation of Cellular Therapy) accredited Cell Processing Facility (CPF) can produce human hematopoietic or immune-competent cells for advanced cell and gene therapy products, specializing in TCR and CAR-T manufacturing processes. The Biologics Processing Facility (BPF) manufactured various products, such as cellular products from microbial and mammalian culture systems, including monoclonal antibodies, fusion proteins, conjugates, plasmids, peptide vaccines and viral vectors. These production services provided by TMSR follow cGMP and include operations staff that are highly trained in clinical manufacturing. All processing facilities and equipment are maintained in a qualified cGMP state and all products are subject to Quality Control testing and Quality Assurance systems that ensure FDA compliance for the safe manufacture and release of clinical trial materials. The TMSR also provides Process Development, Process Engineering and Materials Control resources to maintain high manufacturing success rates and fully facilitate the translation of projects from faculty labs into the cGMP manufacturing facility in a cost-effective, compliant, and timely manner for complex therapy modalities. Through Product Management facilitation, the TMSR works closely with investigators within a series of team structures to ensure informed and appropriate planning, manufacturing process development, production readiness and process performance analysis and improvement. 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 TMSR maintains a strong culture of continuous process improvement. We continue to develop and refine our capabilities through monitoring and analyzing performance metrics. This also enables the development of strategic planning to keep pace with future needs. Additionally, the more recent expansion of our capabilities and services in Process Development and Process Engineering provides for more efficient examination and on-boarding of new manufacturing technologies and equipment.