GMP Manufacturing & Cell Processing

Biological Products for Preclinical Studies and Clinical Trials

Our cell processing program provides biological products for use in preclinical studies and Phase 1 and 2 clinical trials, including immunotherapy and gene therapy products, reagents and peptide vaccines. Our state-of-the-art 6,300-square-foot manufacturing facility meets all FDA Good Manufacturing Practice (GMP) standards. Many of the products developed and manufactured here are used in an outpatient setting at the Bezos Family Immunotherapy Clinic.

Key steps of manufacturing engineered T cells

Facilities

Our facility enables production at a scale exceeding that of most research laboratories. It consists of two clinical manufacturing suites: a biologics production facility and a cellular processing facility, both of which have dedicated quality assurance, quality control, process development and project/program management departments.

Services

  • 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 Cell Processing

Zita Mears

Zita Mears

Director, Cell Processing Facility
Phone: 206.667.2155