SMART CAMP has launched and is actively building our research team!
FLAGSHIP PROJECT 2: SAFETY CQA
Rapid critical quality attributes for safety of cell sources and cell therapy products, informing process analytic technologies and speeding product release.
Why?
Safety of cell therapy products is paramount in the process development and regulatory approval process. If the first goal is to do no harm, the basic expectation is that the medicine is free from contamination including microorganisms that occur naturally in the laboratory space and equipment used to manufacture the cell products. Here, regulatory science and engagement also plays a role, since product safety is a public health concern and the regulatory bodies sets the bar for what must be measured and / or reported.
What we do
FP2 focuses on novel approaches to rapidly detect contaminants, microbial and viral particles, in cells therapy products. We plan to develop multiple approaches and detection technologies in order to tailor for different cell therapeutic applications.