AAV Process Development Guidance Based On Cost Modeling

Production of adeno-associated virus (AAV) and other viral vectors used for gene therapy faces challenges due to high manufacturing costs and process development timelines which may be considerably shorter than what has been used for more traditional biopharmaceuticals. Many process development activities may be undertaken to reduce manufacturing costs, but these costs are often not directly related to the process improvements being considered. In this work, process and cost models were built for AAV production and analyzed to assess the holistic impact of common process development objectives on the manufacturing costs. The insights from these analyzes provide guidance for prioritization of various process development objectives.