FluBlok, a next generation influenza vaccine manufactured in insect cells

Recombinant and epitope-based vaccines on the road to the market and implications for vaccine design and production

“…Unlike the whole-virus based vaccine, which is produced in eggs using technology that is more than 60 years old, 11 FluBlok Ò is produced using the baculovirus-insect cell expression system. 12 In the event of an influenza pandemic or vaccine supply shortage, this manufacturing bioprocess has the potential to start up vaccine production much faster, because the production is not dependent on an egg supply or on availability of the influenza virus. The antigens included in FluBlok Ò correspond to full-length recombinant haemmaglutinin protein (rHA), including the transmembrane domain, the HA1 (stem domain) and HA2 regions (globular head domain).…”

Vaccine effectiveness in older individuals: What has been learned from the influenza-vaccine experience

“…New formulations already tested on older individuals include increasing the TIV dosage (60 g versus 15 g of HA) (Cate et al, 2009;Falsey et al, 2009); changes in the type of vaccine (live attenuated vaccines (LAVs) (De Villiers et al, 2009); virosomal vaccines (Huckriede et al, 2005); and adjuvanted vaccines with MF59 or AS03) (de Bruijn et al, 2006;Pegliasco et al, 2001;Roman et al, 2010;Leroux-Roels et al, 2010). Further formulation changes which are at early stages of development include enhancing adjuvantation of current vaccines (Keitel et al, 2008) or the development of novel adjuvant as the labile enterotoxin from E. coli, placed over the immunization site in a patch (Glenn et al, 2009); the use of life attenuated influenza vaccines (LAIVs) in combination with current vaccines (Monto et al, 2009); DNA vaccines (Drape et al, 2006) and recombinant vaccines (Cox and Hollister, 2009;Treanor et al, 2007); the use of different modes of delivery the viral antigens have been assessed such as intradermal (Holland et al, 2008;Leroux-Roels et al, 2008); and alternative antigens (use of highly conserved maturational cleavage site of HA precursor, the external domain of the M2 protein, and the nucleoprotein) (Bianchi et al, 2005;Livingston et al, 2006).…”

Recent Advances in Our Knowledge of Baculovirus Molecular Biology and Its Relevance for the Registration of Baculovirus-Based Products for Insect Pest Population Control

“…The unique baculovirus properties, coupled with recent advances in molecular and cell biology, have broadened the scope of their application in basic and applied biomedical fields. To date, the prototype baculovirus, AcMNPV, is the most widely used baculovirus for the production of biologics for therapeutic purposes (Aucoin et al, 2010;Cox & Hollister, 2009;van Oers, 2006). This has been accomplished in part by use of baculovirus expression vector systems (BEVs) for heterologous recombinant protein production and gene transfer.…”

“…Furthermore, use of serum-free cell cultures have been recognized by regulatory agencies including the United States, Food and Drug Administration (FDA), and European Medicines Agency (EMA) as a standard approach for limiting potential adventitious agents in therapeuatic products (FDA, 2010). Many advantages of using insect cell substrate compared to embryonated eggs have been reported leading to simplified regulatory avenues for licensing baculovirus-based biologics (Cox & Hollister, 2009, Treanor et al, 2007. In addition to cell substrates, insect larvae such as T. ni , and B. mori (Kato et al, 2010) have been reported as potential biofactories for in vivo therapeutic production.…”

“…For instance, in vivo production of antiviral agents including human interferon-γ against influenza virus H1N1 in T. ni larvae have been demonstrated Gomez-Casado et al, 2011). Nevertheless, insect cell cultures and BEVs platforms continue to expand the applications of baculoviruses as novel tools for vaccine development, drug screening, and gene therapy (Airenne et al, 2010(Airenne et al, , 2011Cox & Hollister, 2009, Kost et al, 2005, van Oers, 2011. The recent initiative of having a standard baculovirus reference material repository (BRM) will further boost their application and perhaps hasten the regulatory process for registering new baculovirus products (Kamen et al, 2011).…”