Wave disposables will help make pandemic flu vaccine
commercial scale production process for the former's pandemic
influenza virus vaccine and other biological products.
The collaboration will make use of disposable mixer/bioreactor technologies developed by Wave and ILC Dover, and reflects an increasing trend among biopharma companies to shift towards the use of plastic disposable components for bioprocessing and away from stainless steel items. The result can be cost-savings on equipment purchases and validation/maintenance time that are estimated at around 40 per cent across a plant.
Initially, the companies will focus on Novavax's H9N2 avian flu vaccine that has shown promising results in preclinical studies, according to the firms. There is concern at present that strains of avian flu, including H9N2, could cross the species barrier and cause a major pandemic amongst humans.
Among the products developed by Wave Biotech is the FlexMixer, claimed to be the first single-use mixing bag that can be used to mix materials of any viscosity or density difference. It can be scaled to over 10,000 litres and does not have any internal impeller or actuator: an integral perforated diaphragm in the mixing bag is moved up and down by a simple low-cost mechanism to provide reliable, efficient and complete mixing.
Compared to traditional mixing systems, FlexMixer integrates materials more completely and efficiently and eliminates the need for cleaning and/or sterilisation between batches, saving companies valuable time and money, according to Wave Biotech.
The collaboration aims to scale up production of Novavax'Viruls Like Particle (VLP) vaccine that has shown promising results in preclinical studies reported last month.
The VLP vaccine approach uses recombinant DNA technology to create components of the influenza virus in structures optimised to elicit a protective immune response. The three dimensional virus like structures are designed to give protection without the risk of infection and without the addition of chemical adjuvants.
The companies will use Wave's disposable product range, inlcuding the FlexMixer, Wave Bioreactor and Sterile Tube Fuser, to make larger quantities of the drug available for clinical testing. Shares in Novavax rose more than 10 per cent on the news to $1.70.
Financial terms of the alliance were not disclosed.
