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.
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: