Viral vectors such as adenovirus, adeno-associated virus, and lentivirus can be used in various therapeutic and vaccine applications, and are expected to become high-value products. As such, there is an increasing demand for fast, reliable, and cost-efficient solutions for viral vector production. While obtaining a safe and efficacious product should always be the top priority of any process development project, it is also important to include considerations regarding cost-efficiency early in the development process to help find a good balance between technical performance and economic feasibility.<br/><br/>Here, we present a project where multiple approaches for harvest and purification of adenoviruses have been investigated. For each unit operation, modern technologies and solutions have been evaluated against more traditional alternatives in terms of purity, yield, and productivity. In the end, two updated processes based on chromatography were selected for purification of adenovirus: one using modern resins, and the other using a combination of membrane adsorber and resin technologies.<br/><br/>At project start, potential processes were modeled using the BioSolve™ process economic simulation tool (BioPharm Services) to identify process alternatives that were unfavorable from a process economy perspective, and as such, could be excluded from the development work. Throughout the development process, the model was improved and subsequently used to provide decision support. Lastly, the potential benefits and drawbacks of the two selected processes, in relation to the more traditional process alternative, were investigated in various production scenarios.

Development of cost-efficient processes for adenovirus purification

255th National Meeting (2018)

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