Product knowledge remains critical for developing reliable methods for quality control. Manufacturers must implement biologically relevant biomarker assays and quality controls for stem cells so that they can assess their critical quality attributes. These quality attributes are vital when conducting comparability studies to design or scale-up a manufacturing process and when releasing clinical materials.
Critical quality attributes include:
To analyze the quality and potency of cells, Merck offers a large portfolio of biomarker assays, including ELISAs, RIAs and MILLIPLEX® Multiplex assays using Luminex®, as well as cost-effective and easy to use flow cytometry.