The project will see PCT - the contract manufacturing firm that made its name by producing Dendreon’s Provenge for clinical trials – evaluate the SistemicQC system for process optimization.
Timothy Fong, PCT’s VP of technology and product development, said: “We are pleased to work with Sistemic to develop assays to better define our developmental cell therapy products. This technology complements our current efforts and should strengthen our understanding of what cells look like and how they function.”
Jim Reid, Sistemic CEO, echoed this, commenting that: “PCT is one of the world’s leading contract development and manufacturing organizations (CDMOs) and, in fact, the only CDMO that can count a client with an FDA approved cell therapy product.
“We aim to assist PCT in developing a more precise understanding of CT products and thereby help the industry to more rapidly bring effective CT products to market.”
microRNA, macro applicaitons
The SistemicQC system is based on microRNA, which are small, non-coding RNA molecules that play a critical role in regulating gene expression and therefore the characteristics of a cell.
This information can be used by drug developers to – for example – better identify a candidate compound’s mechanism of action by analyzing how its impact on a cells’ microRNA profile.
Similarly, the microRNA data can be used to test that cell therapies are produced in a consistent manner, which is precisely how PCT – and Merck Millipore who signed a deal with Sistemic late last year – plan to employ the technology.
News of the agreement with Sistemic follows just two months after PCT was contracted to produce Adaptimmune’s candidate cancer stem cell therapy NYESO-1 for clinical trials, although the CDMO did not say whether this cell therapy will be involved in the tests.
Sistemic was unavailable for comment when contacted by Outsourcing-pharma.com