GMP Production and Scale-Up of Adherent Neural Stem Cells with a Quantum Cell Expansion System.

ABSTRACT: Cell-based therapies hold great promise for a myriad of clinical applications. However, as these therapies move from phase I to phase II and III trials, there is a need to improve scale-up of adherent cells for the production of larger good manufacturing practice (GMP) cell banks. As we advanced our neural stem cell (NSC)-mediated gene therapy trials for glioma to include dose escalation and multiple treatment cycles, GMP production using cell factories (CellStacks) generated insufficient neural stem cell (NSC) yields. To increase yield, we developed an expansion method using the hollow fiber quantum cell expansion (QCE) system. Seeding of 5.2 × 10⁷ NSCs in a single unit yielded up to 3 × 10⁹ cells within 10 days. These QCE NSCs showed genetic and functional stability

SUBMITTER: Tirughana R 

PROVIDER: S-EPMC6037686 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature