SistemQC™ : Quality control for Cell Therapy

SistemQC™ is helping companies carry out quality assessments at key steps in the cell therapy development life cycle; from early R&D stage to scale-up/scale-out, manufacture and batch release stages SistemQC™ provides a generic, low-cost way to characterise and compare the critical quality attributes of cell populations.

SistemQC™ monitors cells for:

• Identity
• Purity
• Potency

SistemQC™ and Cells and Cell lines

With the rapid growth in the cell therapy and stem cells market there has been a great need for cell populations from high quality cell lines. Some of the key issues that are faced by the suppliers and users of cell lines is batch-to-batch and lot-to-lot consistency, benchmarking of cell model system to ensure it is fit-for-purpose and potential for drift of the cell line phenotype over time. At Sistemic, we have developed products to help companies address these key issues.

For cell lines SistemQC™ can monitor cells for:

• The selection of donor cell populations with optimal expansion/performance characteristics
• QC of batch-to-batch consistency from bioprocess runs
• Lot-to-lot variability
• Monitoring phenotypic ’drift’ of cell lines over time

Key benefits of SistemQC™

• Cost effective with a quick turnaround
• Generates early QC alerts at critical points within the process
• Includes QPCR based method for rapid testing
• Supports strategic decision making
• Seamlessly integrates into current workflow
• SistemQC™ acts as a molecular marker
• Multiple quantitative outputs from a single assay

Sistemic’s SistemQC™ is helping cell manufacturers to monitor cells for intended or unintended change easily and time-efficiently within their current workflow process. It is able to check for batch-to-batch consistency quickly and therefore support faster decision making at critical quality control points within their process workflows. This allows them to proceed with confidence that the phenotype of cells they are delivering is consistent. SistemQC™. can also monitor the effect of changes to the production method on the cell phenotype and can be used to measure cell homogeneity. SistemQC™ is suitable for use in all cells (and stem cells) including BHK, CHO, HEK-293, NS0, PER.C6 and hybridomas.