Reliable, scalable cell manufacturing
Develop robust GMP ready protocols that linearly scale from pilot studies to commercial production.
Do any of these sound familiar?
You started your bioprocess career working with cells that behave - CHOs and HEKs. Now you need to develop a bioprocess for a difficult to reproduce protocol with undefined quality assays.
Tacit knowledge of how to successfully culture difficult to grow cells, like iPSCs, is locked in your technical team and an SOP. No matter how well written, you can't instantly transfer this insight to new team members.
The FDA wants your process fully closed. The board is pressing you to make manufacturing processes economically viable. You’re supposed to have all the answers. Yesterday.
Monitor your critical quality attributes in real time with off line sampling and in-line, metabolite based sensing.
Automate and close your process. Codify tacit knowledge with digitized protocols that can instantly transferred between Unicorn systems.
Save time and headaches during process development and unlock a path to save costs and reduce footprint when scaling up through commercial manufacture.
Dr. George Freeman
