Therapeutic Products Program (TPP) Services

Cell Processing Facility
The service provides for reproducible production of human hematopoietic or immune-competent cells under stringent quality control and safety conditions required for therapeutic studies. See more
Clinical Biologics Production
The Biologics Core Facility manufactures products using cGMP as part of the Therapeutic Products Program (TPP) See more
Process Development
Process development includes pre-clinical development of scaled-up optimized production methodologies to satisfy parameters of product yield and functionality, compliance with requisite safety and release specifications and other regulatory requirements, development of standard operating procedures and batch records, and performing pilot studies and validation of key systems prior to process transfer and initiation of full clinical manufacture. See more
Quality Assurance (QA)
Quality assurance (QA) is provided to ensure ensure that the manufacturing and testing of products comply with the Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP), current Good Tissue Practices (cGTP), and other applicable regulations. See more
Quality Control (QC)
The TPP maintains separate quality control (QC) laboratory space to provide product characterization capabilities, such as automated cell counts and flow cytometry, required by the FDA. See more

Doing Business with Therapeutic Products Program (TPP)


(206) 667-6131
jbadams@fredhutch.org