Cox M.M.J.,Protein Sciences Corporation
Expert Review of Vaccines | Year: 2011
Influenza is the most common cause of vaccine-preventable morbidity and mortality despite the availability of the conventional trivalent inactivated vaccine and the live-attenuated influenza vaccine. These vaccines induce an immunity dominated by the response to hemagglutinin (HA) and are most effective when there is sufficient antigenic relatedness between the vaccine strain and the HA of the circulating wild-type virus. Vaccine strategies against influenza may benefit from inclusion of other viral antigens in addition to HA. Epidemiologic evidence and studies in animals and humans indicate that anti-neuraminidase (NA) immunity will provide protection against severe illness or death in the event of a significant antigenic change in the HA component of the vaccine. However, there is little NA immunity induced by trivalent inactivated vaccine and live-attenuated influenza vaccine. The quantity of NA in influenza vaccines is not standardized and varies significantly among manufacturers, production lots and tested strains. The activity and stability of the NA enzyme is influenced by concentration of divalent cations. If immunity against NA is desirable, a better understanding of how the enzymatic properties affect the immunogenicity is needed. © 2011 Expert Reviews Ltd.
Post P.L.,Protein Sciences Corporation
PDA Journal of Pharmaceutical Science and Technology | Year: 2010
■ PSC has developed and qualified a novel, serum-free insect cell line and master baculovirus bank for the production of recombinant proteins. ■ Approval of FluBlok will further validate the new technology. ■ There is an unmet need for a reliable, rapidly available supply of flu vaccine. ■ PSC has developed a robust manufacturing process for FluBlok and PanBlok H1, utilizing the BEVS system, that meets this need. ©PDA, Inc. 2010.
Cox M.M.,Protein Sciences Corporation
Expert review of vaccines | Year: 2012
Vaccine Production Summit San Francisco, CA, USA, 4-6 June 2012 IBC's 3rd Vaccine Production Summit featured 28 presentations discussing regulatory challenges in vaccine development, including the use of adjuvants, vaccine manufacturing and technology transfer, process development for vaccines and the role of quality by design, how to address vaccine stability, and how vaccine development timelines can be improved. The conference was run in parallel with the single-use applications for Biopharmaceutical Manufacturing conference. Approximately 250 attendees from large pharmaceutical companies, large and small biotech companies, vendors and a more limited number from academia were allowed to access sessions of either conference, including one shared session. This article summarizes the recurring themes across various presentations.
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 729.11K | Year: 2006
To improve insect expression system for large scale commercial production, it is important to develop a system that allows real time monitoring of the whole production process without physical sampling, and is able to produce proteins of high quality and high yield. Our Phase I study has demonstrated the feasibility that a new DNA transfer vector with 6 new features is able to express recombinant proteins of high quality and in large quantities, and can be used for real time monitoring. The objective of this research project is to further develop this novel system by incorporating a fiber optic probe into bioreactors to perform real time monitoring, and by optimizing the procedure for Factor Xa treatment. We will apply this new technology to make influenza hemagglutinin in three 45L fermentations. The quantity and quality of the HA produced in this new system will be evaluated. PSC with work with Teledyme Analytical Instruments to select, optimize, and integrate a fiber optic probe into our production system.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 487.34K | Year: 2007