Scaling CGT through automation

Cell and gene therapies need to be made cheaper. Much cheaper. With price tags in the millions, they will never be able to deliver on their promise of personalized cures at scale.It will take time for the industry to take costs below $1m per dose from the typical current price in the $2m-3m range. And even this reduction is nowhere near enough to reach patient populations beyond the richest countries and health systems.  More automated manufacturing offers one of the most significant ways to cut costs. The sector has been moving hospital lab manufacture towards more standardised and repeatable processes in dedicated facilities, but there ’s still a long improvement path to travel. Production processes remain highly complex. The absence of established platform technologies means that bottlenecks and batch errors remain common features.  The upstream and downstream processes from creation of the plasmid through to the bioreactor process and then to the creation of a pure, concentrated drug substance and final packaging into vials, require hundreds of quality tests and many variables.  Even small changes in production parameters can result in a failure or low yields.  “It’s not like a small molecule. There are so many variables and parameters to check,” says Oscar Segurado, Chief Medical Officer at ASC Therapeutics, adding that the regulatory documentation process, running to thousands of pages, is another non-trivial source of work and expense.The only viable way f...
Source: EyeForPharma - Category: Pharmaceuticals Authors: Source Type: news