Therapeutic Products Biologics Production Facility

Manufacturing Biologics Products

Our Biologics Production Facility (BPF) provides both early-phase (preclinical) and clinical (Phase 1) current Good Manufacturing Practice, or cGMP, manufacturing capabilities for a range of cellular-based products from eukaryotic and prokaryotic culture systems. These products include monoclonal antibodies, fusion proteins, conjugates, plasmids, viral vectors and peptide vaccines. 

Our trained, qualified personnel conduct all manufacturing activities using approved written procedures in accordance with cGMP guidelines. We provide quality assurance oversight and review to ensure regulatory compliance and the safety of therapeutic products.

 

ON THIS PAGE

Virtual Tour   |  BPF Facility and Services   |   Clinical Vector Process Development

Schedule With Us

To start a collaboration with us, contact the BPF director or review our product management information. 

Dr. Mark Rice
Director, BPF, and Interim Director, Process Development


 

Video by Robert Hood / Fred Hutch News Service

Take a Virtual Tour

This virtual tour takes you inside the Therapeutic Products shared resource’s BPF to learn about the processes, facilities and equipment for producing high-quality biologics for preclinical studies and clinical trials. Highlights:

  • Process development lab and nonclinical project space
  • Quality control lab
  • Clinical production suite

Go inside the BPF and learn about our work.

BPF Facility and Services

Expand All
Our Facility

The BPF occupies 2,770 square feet within the Hutchinson Building and comprises nonclinical and clinical production areas and support space. The quality control laboratory occupies 476 square feet next to the main facility. The core of the facility is the clinical production suite and the fermentation suite, which occupy 1,500 square feet. Clinical manufacturing is campaigned with rooms dedicated to the production or purification of one product at a time.

Design and construction of the clinical production suite was guided by the principles outlined in the Food and Drug Administration's Points to Consider (1994), FDA Guidelines on Sterile Drug Products Produced by Aseptic Processing (1987) and Biotechnology Facility Requirements Parts I and II, by Donald Hill and Michael Beatrice, Biopharm (1989). These design and construction features ensure appropriate control of product flow and product quality.

Scientists in the lab
The BPF purification suite Photo by Robert Hood / Fred Hutch News Service
BPF Services

The BPF’s services include the following:

  • Production of lentiviral vectors
  • Development and optimization of monoclonal antibody-based therapeutics for clinical investigational trials, with associated quality control and regulatory support
  • Production and purification of monoclonal antibody reagents for research, bulk cell culture and antibody conjugation
  • Development of purification processes for protein-based biologicals 
  • Production and purification of vaccines
  • Quality control testing services
Lab
The BPF upstream processing suite Photo by Robert Hood / Fred Hutch News Service
Lorem ipsum

Clinical Vector Process Development

Our clinical vector process development team, directed by Dr. Hans-Peter Kiem, provides development, production and quality control of clinical-grade virus vectors that can be used to genetically modify primary cells for clinical protocols. The team currently uses lentiviral and AAV vectors primarily but is expanding to other viral vectors.

For more information about our clinical vector process development, contact Staff Scientist Dr. Megha Gupta.

Questions about our Biologics Production Facility or how to schedule with us?