Influenza vaccinations are critical to public health. The world influenza vaccine market is projected to be over US$7 billion and growing at an average rate of >20% per year. Last year, more than 500 million doses of vaccine were manufactured and used. All were derived from well-established egg-based production systems. Over the last several decades, numerous strategies have been employed in an attempt to increase the specific productivity of egg-based influenza vaccine manufacture. These include solvent extraction of influenza virus from infected allantoic fluid by multiple treatments, protein precipitation and ion exchange chromatography. However, in nearly all these methods allantoic fluid is pre-clarified before treatment and, as such, they ignore the potential for the presence of virus particles that may be physically associated with insoluble allantoic debris.
Microbix’ proprietary VIRUSMAX technology is a rapid, non-toxic technique for increasing the specific yield of multiple strains of influenza virus from the allantoic fluid of embryonated chicken eggs. Numerous studies have been performed in allantoic fluids from a wide variety of commercial and non-commercial sources. Liberation of intact insoluble debris phase-associated influenza virus, using strain-optimized extraction buffers, significantly augments viral yield. Such increases in viral yield can be can be used to increase the productivity of standard downstream influenza vaccine manufacturing processes.
Microbix VIRUSMAX technology has been shown to increase virus yields in numerous strains under numerous manufacturing scenarios (Hughes et al. Vaccine (2007) 25, 4456). The level of optimization varies by virus strain and type. Estimates of overall enhancement for a typical trivalent vaccine production are at least two-fold.
Microbix has been granted patents in the USA, Canada, Mexico, Argentina, Europe, Italy, India, Japan, Australia and China.
Microbix has chosen to license the VIRUSMAX technology on a regional basis, starting with countries where vaccine supply is most deficient. Licenses are initially available to local domestic manufacturers, multinational manufacturers with facilities in the licensing region, and/or start up manufacturers’ facilities. The terms for such licenses are structured to include upfront and royalty payments.
Microbix created Crucible International Biotechnologies (CRIB) to implement the VIRUSMAX commercialization strategy. CRIB is a licensing, investment and management entity. CRIB is responsible for selecting regional partners to build influenza vaccine facilities. Its contribution to the partnership includes exclusive regional licenses and experienced industry management in exchange for equity in the regional venture company. CRIB will also receive royalties on the sale of vaccine product.
CRIB is in discussion with two countries. The existing seasonal influenza vaccine market in these countries is small and under-developed, typically less than 2% of the target population. The majority of the vaccine supplied to these markets is imported from multinational vaccine companies. The objective of the CRIB venture is to bring increased supply of an international standard flu vaccine to new markets, vaccinating in the range of 15 to 20% of target populations, approaching vaccination levels as recommended by the WHO.