Sistemic and QCMD announce an innovative collaboration aimed at addressing the need for quality assurance and standardisation in the cell therapy

Release Date: October 15, 2013

Sistemic Ltd and QCMD Ltd (Quality Control for Molecular Diagnostics) announced today that the companies had entered into a cross-licensing agreement.

The arrangement centres on Sistemic’s SistemQC™ technology which is widely used by companies developing cell-based therapies allowing characterisation of the cell products and development of potency assays for product release and QCMD’s proprietary informatics platform and characterised quality assurance materials. Jim Reid, CEO of Sistemic said “the combination of Sistemic’s leading-edge cell therapy characterisation technology with an established leader in the field of molecular external quality assurance allows us to move a stage closer to employing our SistemQC™ technology at the point of use where current technologies cannot offer the speed, discrimination or sensitivity required to properly test cell products.

The cell therapy industry has a huge amount to offer patients and healthcare systems but without standardisation the industry will always struggle to gain wider use. Sistemic is delighted to have reached this agreement with an organization that has done so much to progress quality assurance and support standardisation in molecular testing in the clinical field and is looking to build on that experience to ensure that best practice is adopted in cell therapy development and testing as soon as possible. With over 300 products in the clinic, the cell therapy industry is developing and will become a part of standard practice for many untreatable diseases. Sistemic and QCMD want to make sure that standards and external testing of laboratories, which will be necessary for this broader use, are ready to ensure the highest levels of product quality and efficacy” 

 

Dr. Paul Wallace, QCMD Executive added “The development of smart informatics tools and suitable controls for the quality assurance of cell therapy products and procedures is crucial to the future development of the cell therapy industry. This collaboration will aim to establish ways of monitoring for the potential contamination of cell therapy products as well as investigate best practice and support the development of appropriate controls and support standardisation”. There is no doubt that the field of cell therapy holds great promise for treating many diseases which present such a challenge to patients and healthcare systems alike today. Controls and Standards will be a key part of progressing this industry to routine use and both Sistemic and QCMD see this licensing arrangement as a critical step in the process towards this.