Cells, Cell Therapy and Stem Cells

We have developed a pioneering product range that aims to provide the standard in cell characterisation and Quality Control (QC). Our product, SistemQC^TM, was developed to address a large unmet need in the Cell Therapy and Stem Cells market for more sophisticated characterisation tools that could be linked back to the biology. SistemQC^TM leverages the instructive power of miRNA based fingerprinting to provide robust and information-rich characterisation and QC methods, applicable to all cells including stem cells. These products are helping companies worldwide to carry out research and deliver therapies successfully whilst providing knowledge-rich and instructive data on a range of cell systems.

Cell Therapy and Stem Cell market has been growing very rapidly in recent times, with market size expected to be $5 billion by 2014⁽¹⁾. This enormous interest is because of its potential to replace defective or damaged cells resulting from a variety of disorders and injuries, potentially leading to a range of new generation of treatments for some of the most challenging and intractable chronic diseases we face. A large unmet need within this field is the lack of robust Quality Control (QC) tools that can monitor cells easily, in a time-efficient manner. This is hugely important for organisations as they strive to carry out research and development of cell therapies within budget and are constantly looking at methods to reduce the costs of goods and time involved. At Sistemic, we have developed our products to help companies do just that.

Our SistemQC^TM product is helping companies carry out key research and development by providing QC and characterisation methods to monitor cells easily and effectively while seamlessly fitting within their current workflow process. SistemQC^TM fits in with companies at all stages of the development process, from early R&D stage to the Scale-up/Scale-out, manufacture and batch release stages. SistemQC^TM can monitor cells and stem cells for identity, drift, differentiation staging and purity robustly and in a timely fashion. This allows for companies to gain key insights within their systems and therefore support strategic decision and reduce costs.

SistemQC^TM monitors cells for:

• Identity
• Potency
• Purity
• Characterisation
• Markers for differentiation staging

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. A large number of Cell manufacturers have established cell banks, in recent years, to provide characterised quality cell populations crucial for the success of the cell therapy and stem cell market. 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^TM can monitor cells for:

• QC of batch-to-batch consistency
• Benchmarking cell models
• Lot-to-lot variability
• Drift of cell lines over time

Sistemic’s SistemQC^TM 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 QC points within their process workflows. This allows them to proceed with confidence that the phenotype of cells they are delivering is consistent. SistemQC^TM can also monitor the effect of changes to the production method on the cell phenotype and can be used to measure cell homogeneity. SistemQC^TM is suitable for use in all cells (and stem cells) including BHK, CHO, HEK-293, NS0, PER.C6 and hybridomas.

SistemQC^TM

SistemQC^TM uses the proprietary Sistemic methodology to combine robust miRNA profiling with superior statistical analytics and multi-layered contextual analysis to generate a fingerprint of key miRNAs (kmiRs) together with their underlying biological interpretation in a cost-effective and time-efficient manner. Moreover, the generated kmiR fingerprints can be adapted to a QPCR method for ease of integration and rapid testing. SistemQC^TM therefore supports faster decision making at critical points within process workflows, allowing companies to proceed confidently with their cell populations.

Moreover, SistemQC^TM can monitor cells and stem cells for identity, potency, purity, characterisation, markers for differentiation staging, benchmarking cell model, and QC of batch-to- batch consistency.

Key benefits of SistemQC^TM:

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

If you work with cells or in the cell therapy and stem cells industry, there are a number of ways we can help you. Please contact us and we would be happy to talk to you.

For more details on how we work with companies please click here.

1. Evers P. (2009) Advances in the Stem Cell Industry: Business Insights. Pg: 70-74