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Product Quality Assessment and Biomarkers
for Stem Cell Therapy

Guava easyCyte™ Flow CytometersProduct 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:

  • Cell identity and purity to confirm that the product fits its description
  • Confirmation of product quality through biological functions or potency ideally suited to their clinical applications
  • Product safety profile
  • Product efficacy measured through clinical data

Stem Cell Therapy Manufacturers Need Reliable Product Quality Assays and Biomarkers

To analyze the quality and potency of cells, MilliporeSigma 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.