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.
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Virtual Tour | BPF Facility and Services | Clinical Vector Process Development
Schedule With Us
To start a collaboration with us, review our product management information or contact us at:
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.
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.
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
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.