Feasibility of A Suite of Analytical Methods for Characterisation of Active Virosome Vaccine Candidates

“actiactirosome开发有效的、负担得起的疫苗，以迅速应对新的感染暴发，并预防和保护人类和其他动物免受严重疾病的侵害。我们开发了一系列活性病毒体（AV）疫苗，处于临床前概念验证阶段：我们在相关传染病的小动物模型中证明了它们具有免疫原性，并产生了保护作用。在开始毒理学和药代动力学研究之前，我们必须对它们进行表征和优化，这是监管部门批准的基本要求。然而，我们有四个分析和表征问题，这是目前进展的障碍。本项目探索解决方案。该项目旨在证明使用我们的A4I合作伙伴NPL提出的一系列分析方法解决这些问题的可行性。activirosome和NPL汇集了专业知识和设备来执行本申请中描述的研究，并将共同努力解释和应用结果。研究结果及其解释可能会确定在我们实施解决方案之前需要调查的其他障碍或相关子问题。结果还将使我们能够确定，除了本研究中使用的设施外，是否还需要其他设施或专业知识来解决问题。我们将在后续研究中探索这些额外的障碍。”

"Activirosomes develops effective, affordable vaccines to respond quickly to new infection outbreaks and to prevent and protect against serious illnesses in humans and other animals.We have developed a series of Active Virosomes (AV) vaccines to pre-clinical proof of concept stage: we demonstrated that they are immunogenic and create a protective effect in small animal models of the relevant infectious diseases. We must characterise and optimise them before starting toxicology and pharmacokinetic studies, and as an essential requirement for regulatory approval.However, we have four analysis and characterisation problems that are currently a barrier to progress. This project explores solutions. This project aims to demonstrate feasibility of solving them using a series of analytical methods proposed by our A4I partner, NPL.Activirosomes and NPL bring together the expertise and facilities to perform the study described in this application and will work together to interpret and apply the results. The results of the studies and their interpretation may identify other barriers or related sub-problems that need investigation before we can implement the solutions. The results will also enable us to determine whether additional facilities or expertise are needed to solve the problem, in addition to those used in this study. We will explore these additional barriers in follow-up studies."