Cell and gene therapies have been advancing quickly from clinical research with many market approvals anticipated yearly. Speed is of the essence, which is why having a partner who knows what’s expected in regulated environments, has the flexibility to serve your unique needs, and can assist across your entire value chain is so important. Thermo Fisher Scientific Patheon has the expertise and flexibility you need to continue moving at a rapid pace.
Thermo Fisher Scientific Patheon has been active in pharmaceutical manufacturing for over 20 years. We know what regulatory authorities are looking for and how to design facilities compatible with commercial therapeutics so you can meet Pre-Approval Inspections requirements and start manufacturing quickly.
Our expertise across various therapeutic strategies (eg: different cell types, genetic modification technologies, autologous, allogeneic, etc) combined with our ability to build a facility according to your specifications means we have the flexibility to support your unique process. A “just-in-time” strategy for facility buildout means we can complete your space in less than 9 months from time of order to facility qualification. Let’s build your solution together.
Not only do we offer process and analytical development, GMP space and manufacturing expertise, but we can also serve you with customizable apheresis collection kits and associated clinical/manufacturing site storage and logistics. That means our service offering spans from the start of patient material collection all the way to the finish line of delivering finished clinical material to patient treatment sites.
Cell and gene therapeutic development is advancing quickly from clinical discovery research to pre-clinical and clinical development phases. That’s why we are investing in strategic partnerships that combine Thermo Fisher Scientific Patheon’s product and CDMO expertise with partner insights to develop processes and products to advance therapeutic workflows and expedite successful commercial and patient outcomes.