Extensive Experience with CGMP Manufacturing for Phase III Trials
We have over
In particular, we help organizations pave the way towards reaching commercial manufacturing readiness—identifying issues that impact the quality, scalability, sustainability, and cost of goods for their cell therapy product and providing advice for overcoming them.
Automation and Closed Systems
We can automate many cell therapy manufacturing processes, including the finishing and filling of a
By automating the fill/finish process, we can minimize the risk of last-minute product contamination and failure in the cleanroom. By creating closed systems, we can run multiple therapeutic cell manufacturing processes concurrently—increasing our productivity so we can complete more batches of therapeutic cells in less time. Our automation also allows us to integrate many manufacturing steps into a single process to further maximize consistency and speed of production.
Cryopreservation of Cell Therapy Products
Our controlled-rate freezers enable us to apply cryopreservation to cell therapy products, increasing the potential distribution area of your CTPs by prolonging their shelf life—something that is a common limiting factor for many cell therapy products.
Combined with our extensive distribution network, which includes special partnerships with air carrier fleets we can significantly extend the reach of your cell therapy product.
ISO 7 and ISO 6/Grade B Cleanrooms
In the U.S., we have two
Some of the systems and services that all of our clients can benefit from include: