H3N2 Challenge Virus (SGS) – an influenza virus for use as a challenge agent that has lineage from the seasonally epidemic, non-haemagglutinating H3N2 viruses that arose in the 2010-2011 influenza season, and that have come to predominate since 2014-2015. Thus, the H3N2 Challenge Virus represents one of the most common current circulating strains of influenza of a pandemic origin and can be used for testing the H3N2 portion of prospective prophylactic and therapeutic vaccines. It shows clear and progressive symptomology characteristics of a mild influenza like illness. Previous influenza challenge agents can demonstrate egg-adaptation and amelioration of disease (both infectivity rates and viral shedding).
When seeking FDA approval for a vaccine, manufacturers require proof of real-world efficacy, which can be achieved in studies in the community; however, the trials are expensive and the low rates of infection can lead to the need for an enormous patient pool. A challenge agent with a high infection rate – used in conjunction with controlled, human infection studies – could help reduce reliance of efficacy programs on the seasonal incidence of influenza. The efficacy of the vaccines can be determined directly by measuring both virological and host (clinical) endpoints. Maintaining the safety of subjects, whilst maximising data relevance (quality), allows informed go/no go decisions to be made earlier in the pipeline development cycle.
2017 Runners Up
HakoBio (OUAT!) – a 3D and digital reality space for simulating processes and plants. HakoBio was previously used exclusively by Pall Life Sciences, but the technology was commercially launched in 2017, with users now including the UK’s Cell and Gene Therapy Catapult, Sanofi, and Beckman Coulter. HakoBio is a simple web application that allows users to create processes or design labs, and then view the creation – and assess its ergonomics – using virtual reality. Users can select from a vast array of biopharma technology (including specifications and functionalities) modelled in realistic 3D, which can be dragged and dropped to ensure it fits your lab. The interface can also be used for cost and flow simulations, as well as training and data management.
MabSelect PrismA (GE Healthcare) – a protein A resin to boost monoclonal antibody purification capacity. According to GE Healthcare, MabSelect PrismA can help mAb producers to improve their purification capacity by up to 40 percent thanks to its enhanced binding properties. Protein A chromatography resins play a fundamental role in mAb purification efficiency thanks to their high selectivity, but the drawback is a lack of chemical resistance and the relatively low productivity of many protein A resins. MabSelect PrismA has been developed using high-throughput screening methodologies to identify and resolve weaknesses in the protein A molecule that make it susceptible to sodium hydroxide degradation – allowing MabSelect PrismA to be cleaned with a higher concentration of sodium hydroxide to better control cross-contamination and bioburden risks.
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