Therapeutic Products Program
Process Development and Manufacturing for Clinical Trials
The Therapeutic Products Program shared resource at Fred Hutchinson Cancer 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.
Our Services
Cell Processing
Our Cell Processing Facility is a GMP bioprocessing manufacturing facility that supports the reproducible, compliant production of human hematopoietic or immune-competent cells for Phase 1/2 clinical trials under stringent quality control and safety requirements.
Biologics Production
Our Biologics Production Facility provides preclinical and clinical (Phase 1) current GMP manufacturing capabilities for cellular-based products from eukaryotic and prokaryotic culture systems, including monoclonal antibodies, fusion proteins, conjugates, plasmids, viral vectors and peptide vaccines.
Quality
Our quality team is responsible for the execution of suitable methods to characterize our Phase 1/2 cell therapy and biologics products, and for managing our quality management system. We ensure that all our products are fit for intended use.
Our Organization
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 control and assurance 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, TPP 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.
Our Team at Work
Our team of experts is committed to supporting the development and manufacture of high-quality, compliant biologic and cellular therapies for early-stage clinical trials.
From concept to product delivery
A cell processing associate places media into a pass-through to be received into the CPF.
BPF purification suite
Process development support of the CPF
Accessing SOPs online for operation of the Miltenyi Prodigy instrument within the CPF.
Our quality control lab supports several different analytical methods, including flow cytometry, cell-based methods, nucleic acid-based technology and ELISA methods.
From concept to product delivery
A cell processing associate places media into a pass-through to be received into the CPF.
BPF purification suite
Process development support of the CPF
Accessing SOPs online for operation of the Miltenyi Prodigy instrument within the CPF.