Our Cell Processing Facility (CPF) is a Good Manufacturing Practice, or GMP, bioprocessing manufacturing facility that supports the reproducible production of human hematopoietic or immune-competent cells under stringent quality control and safety requirements for therapeutic studies. Our CPF team aims to consistently deliver safe and compliant cell therapy products for Phase 1/2 clinical trials.
Located in the E level of the Thomas Building, the 3,700-square-foot, controlled-access facility consists of four separate suites designed for cell culture, material preparation and various clinical processing operations. The CPF is controlled by a building management system with an independent HVAC system maintaining ISO 7 specifications.
Most of our products are for T-cell therapies, specifically chimeric antigen receptor (CAR) and T-cell receptor (TCR) therapies.
Other products we’ve manufactured and services we’ve provided include the following:
Our investigator clients provide us with the manufacturing production processes, which our process development group may develop further. Our process engineering group works with the investigator and/or process development to facilitate a process transfer, which ensures we understand the production steps in order to create the production batch records required for execution traceability.
Our materials control function ensures procurement, receipt, release and appropriate inventory of all goods and raw materials we need to produce GMP clinical product.
Our production scheduling function works with the clinic to coordinate product delivery and ensure all necessary process steps are appropriately scheduled and assigned.
We use quality assurance-approved standard operating procedures performed by trained, qualified personnel in accordance with cGMP. We are supported by the quality team to ensure regular compliance and safety of our therapeutic products.
All aspects of the CPF are maintained according to specifications set by Code of Federal Regulations title 21, sections 210 and 211, to meet current GMP (cGMP).
The CPF uses various biopharmaceutical manufacturing technologies to establish one-per-patient, parallel production of cellular therapeutic products. These technologies enable us to drive cost effectiveness, process efficiency and product consistency for the manufacturing process.
Cell production operations can include enrichment or depletion of specific cell subsets, provision of normal donor feeder cells, maintenance of transformed feeder cell lines, cloning, ex vivo antigen priming, cytokine and antibody-based activation, genetic modification, expansion, cryopreservation and/or preparation for infusion of many different types of extensively manipulated cell populations.
The manufacturing suites that support the production of cellular therapeutics are equipped with ISO 5 biological safety cabinets and numerous double stack Thermo Steri-Cult humidified CO2 incubators. Other major equipment includes floor and tabletop centrifuges, cell washers and large-scale cell enrichment devices.
This automated cell counter provides consistent cell counting and analysis using state-of-the-art image cytometry.
The blood cell counter uses fluorescence flow cytometry technology to provide complete differential blood count for all white blood cell populations.
This instrument automates cell separation for clinical enrichment of target cells or depletion of unwanted cells in a closed and sterile system.
The Prodigy is a closed system that offers automated cell processing capability, from cell separation through cell culture to formulation of the final product.
This microfluidics chip-based cell sorter features comprehensive fluidics controls, advanced automation and easy-to-use software.
The Sepax C-Pro is a closed and automated cell processing system (automated Ficoll) that uses single-use kits and custom software to automate multiple steps of the manufacturing process.
This automated, closed system washes and volume-reduces cell products through spinning membrane filtration.
This system delivers an automated, controlled expansion environment for the growth of cell therapies in volumes up to 25 L across research, process development and manufacturing operations.
The CryoMed controlled-rate freezers offer customizable freezing profiles.
Our LN2 storage system provides a cryogenic storage solution with high capacity to store 2 mL and 5 mL vials and cryobags.
Process development services include the following:
Our product management team owns the process we depend on to ensure your successful IND submission, GMP-compliant manufacturing and on-time delivery of high-quality product to patients.
Complete our new clinical trial intake form to initiate a new collaboration with us.
Drawing on industry-based technical knowledge, our product management team tracks key advancements in clinical cell therapies and emerging technologies at Fred Hutch, partnering with scientific, regulatory and business development teams to assess investigator-initiated therapeutic products and outside business opportunities.
For other information about how we can work with you, contact our Technical Product Manager, Cell Therapy, Lara Kropp.