Gene therapy has the potential to change countless patients’ lives. Diseases that lacked cures or even treatments may be addressed with these new classes of therapeutics. This potential has spurred new investments in the drug development and commercialization space.
Viral vectors are often challenging to produce, especially at the large scales needed to reach the potential of these therapies. The manufacturing process for gene and cell therapies is complex and the current scale-out approach does not support robust industrialization. By developing a process with scale-up capabilities early on, you can address both clinical and commercial needs. This will minimize unnecessary process changes and the comparability studies required to demonstrate product equivalence.
In this article, we’ll dive deep into the importance of scalability in viral vectors with Eva Fong, Senior Scientist at MilliporeSigma.