Therapeutic Products Program

Labs / Projects

Therapeutic Products Program

Offering cGMP development and manufacturing expertise for biological products and cellular therapies

The Therapeutic Products Program, or TPP, offers development and manufacturing expertise for novel biological molecules (e.g., monoclonal antibodies and recombinant proteins) and cell-based therapies (e.g., CAR T cell and engineered T-cell products) for preclinical testing, and for Phase 1 and Phase 2 clinical trials. 

Expert staff members within the TPP have developed cellular products in current Good Manufacturing Practices, or cGMP, for use in T-cell therapy clinical trials, gene therapy approaches and more. The Cellular Processing Facility produces an average of 10–15 cellular infusion products per month, with the capacity to more than double that in the future. Many of those products are used in an outpatient setting through the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance, Fred Hutch’s clinical care partner. Immunotherapy products from this facility have been used in a variety of hematologic malignancies as well as solid tumor clinical trials, including melanoma and breast, lung, ovarian and prostate cancers. The TPP also produces a variety of clinical-grade biological products, including monoclonal antibodies, fusion proteins, conjugates, plasmids, lentiviral vectors and peptide vaccines.

Facilities

The TPP occupies approximately 6,300 square feet and allows for production at scales that exceed most research laboratories. The facility consists of two separate clinical manufacturing suites: a Biologics Production Facility and a Cellular Processing Facility, both of which support production under current Good Manufacturing Practices and have dedicated Quality Assurance, Quality Control, Process Development and Project/Program Management departments.

Services Provided

  • Production of clinical trial materials
  • Process development and operations optimization
  • Assay development and characterization support
  • Reagent production
  • Preclinical cell production services
  • Quality Control testing
  • Quality Assurance
  • Project/Program Management
  • Regulatory support, including:
    • Chemistry, Manufacturing and Controls (CMC)
    • Drug Master File (DMF)
    • FDA pre-IND and IND authorship support and guidance

Contact

James Adams, Senior Administrative Director
206.667.6131
jbadams@fredhutch.org