M103a - Intensifying the Viral Vector Manufacturing Process: Challenges and Progress

With several recent FDA approvals and a strong drug pipeline, gene therapy is coming of age. With this comes the requirement to ensure that there are robust manufacturing processes in place in order to scale with demand and to make these therapies readily accessible to those who need them. However, current manufacturing processes for gene therapies have often been developed with limited scalability in mind and large shifts in technology have to take place to enable industrialization. This also has to be done while keeping costs in mind. Here, we will present the challenges and solutions to scale up process steps required to develop manufacture iCELLis bioreactor process for scalable production, purification and analytics of AAV viral vector. After implementation of a large-scale of the entire process, we offer the client scalability and speed to the market