With multiple products on the market, gene therapy has now gone beyond proof of concept and entered mainstream healthcare. This success urgently requires work on manufacturing processes to ensure that gene therapies are widely available to all that need them. Furthermore, regulatory authorities, tasked with assuring quality, efficacy and safety of the final product, are placing increasing scrutiny on the manufacturing process. Regulatory guidance documents suggest that the risk of adventitious agent contamination should be assessed and mitigated through a risk-based approach.
In this webinar, we will outline key considerations in choosing the right technology for scale up in adherent and suspension cell cultures and some of the pitfalls that must be overcome to ensure success at large scale. Furthermore, we will detail a process control strategy to mitigate the risk of adventitious agent contamination.
Participants will learn: