Commercial‐scale biotherapeutics manufacturing facility for plant‐made pharmaceuticals
Abstract
Rapid, large‐scale manufacture of medical countermeasures can be uniquely met by the plant‐made‐pharmaceutical platform technology. As a participant in the Defense Advanced Research Projects Agency (DARPA) Blue Angel project, the Caliber Biotherapeutics facility was designed, constructed, commissioned and released a therapeutic target (H1N1 influenza subunit vaccine) in LED lighting. The facility can commission additional plant grow rooms that are already built to double this capacity. In addition to the commercial‐scale manufacturing facility, a pilot production facility was designed based on the large‐scale manufacturing specifications as a way to integrate product development and technology transfer. The primary research, development and manufacturing system employs vacuum‐infiltrated Nicotiana benthamiana plants grown in a fully contained, hydroponic system for transient expression of recombinant proteins. This expression platform has been linked to a downstream process system, analytical characterization, and assessment of biological activity. This integrated approach has demonstrated rapid, high‐quality production of therapeutic monoclonal antibody targets, including a panel of rituximab biosimilar/biobetter molecules and antiviral antibodies against influenza and dengue fever.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Sep 21, 2015
- Source ID
- 10.1111/pbi.12469
Entities
People
- Barry R. Holtz
- Brian R. Berquist
- Don C. Wilkerson
- Earl L. White
- Kah‐yat I. Wong
- Lan H. Ly
- Lindsay D. Bennett
- Ranjith K. Munigunti
- Sylvain Marcel
- Vally J.m. Kommineni
Organizations
- Cancer Prevention and Research Institute of Texas
- Defense Advanced Research Projects Agency