The Therapeutic Products shared resource at Fred Hutchinson Cancer Research Center provides facilities and services in process development and manufacturing of Good Manufacturing Practice (GMP)-grade biologic and cellular therapeutic products for Phase 1/2 clinical trials. Our vision is to support the translation of ideas from academic laboratories to clinical trials.
Interested in a collaboration with us? Make an inquiry via our product management team.
We have two manufacturing production facilities, the Cell Processing Facility, or CPF, and the Biologics Production Facility, or BPF. Many aspects of these operations must be continuously controlled, maintained, compliant and optimized to achieve our goals in support of clinical trials.
These two production facilities are supported by our process development team, which works to assist with process and technology transfer from research laboratories, with a focus on manufacturability and fit into the GMP production environments.
Our quality team also supports our facilities by providing quality assurance oversight per Food and Drug Administration requirements, ensuring safety and compliance to cGMP. This team’s quality control function assists in assay development and executes these assays to test and release products to the clinic.
Finally, the CPF is also supported by teams in product management and GMP materials control, plus other resources to ensure appropriate control of our facilities, utilities and equipment.