As the FDA signals stronger support for advancing gene therapy approvals, manufacturers face increasing pressure to get to market quickly while maintaining viral vector quality. This article tackles emerging scale-up challenges to efficiency and safety, with an in-depth look at strategies to optimize viral vector production, manage costs, and collaborate on industry standardization and automation.
In the rapidly evolving world of cell and gene therapies, innovation is essential if we want to revolutionize medicine. Collaboration in the early stages of development allows us to optimize workflows and apply rigorous quality standards, moving therapies forward without regulatory delays. Our innovative aseptic fluid transfer technologies improve process quality and reduce contamination risks. With a comprehensive global supply network and expert regulatory support from our innovation centers, we help you avoid costly delays and ensure the successful delivery of life-changing therapies.
Scaling up the production of viral vectors, particularly adeno-associated virus (AAV), remains wrought with challenges. The issues of low titer and yield, and vector degradation such as unfolding, aggregation and oxidation, need to be better understood and managed by carefully optimizing buffer, pH and excipients. This article addresses key advancements at each step in the workflow — from maximizing titer output at scale upstream to optimized formulation compositions at fill/finish — to support commercial scale.
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Published: April 15th 2021 | Updated:
