Recombinant Adeno-associated virus (rAAV) has emerged as a gene therapy vector of choice for multiple clinical applications. Current manufacturing techniques for AAV production have been successful in cases of treatment of rare diseases or dosing strategies which have required low to moderate vector amounts. However, as clinical indications move into non-rare diseases or for treatments which require higher vector doses (e.g. if systemic administration is intended), it becomes necessary to better understand and further intensify rAAV manufacturing platforms. This presentation highlights Voyager Therapeutics’ Sf9/baculovirus rAAV manufacturing platform and efforts in identifying and optimizing critical process parameters to enable high volumetric productivities at the desired product quality. The impact of process variables, such as temperature, pH, and mass transfer, on process performance and scalability was studied, and DOE studies to optimize infection timing and Multiplicity Of Infection (MOI) were also executed to achieve desired quantity and quality of product. Different cell culture media have also been evaluated to enhance cell specific productivity while maintaining product quality. This comprehensive approach to upstream process development has resulted in a robust and scalable manufacturing process that consistently delivers a high-quantity and high-quality clinical grade rAAV product.

Critical process parameters for baculovirus infection of a rAAV Sf9 manufacturing process and their impact on quality attributes

2019 Spring National Meeting

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