In order to move product development forward, the majority of biotech companies and academic institutions involved in cell-based therapies need new facilities in order to scale up production capabilities and comply with evolving regulatory requirements. Some institutions choose to use a contract manufacturing organization (CMO) to benefit from established expertise while others support their clinical development programs with their own dedicated production facility. The main challenges in establishing a dedicated pilot-scale production facility are described hereafter…
JUST PUBLISHED: "Standardized and GMP-Ready, Closed-System Processing of Expanded Adipose-Derived Stem Cells Using the Gibco CTS
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