Want to make sure that standards and external testing of laboratories are ready to ensure the highest levels of product quality and efficacy
Sistemic and Quality Control for Molecular Diagnostics (QCMD) have entered into a cross-licensing deal. The deal is centred on Sistemic’s SistemQC technology, used by companies developing cell-based therapies, and QCMD’s informatics platform and characterised quality assurance (QA) materials.
Sistemic provides microRNA-based problem-solving services and kit-based products. Its SistemQC is used to characterise cells, including stem cells (cell identity, purity, potency, and safety), as well as monitoring production QC.
QCMD is an independent international external quality assessment (EQA)/ proficiency testing (PT) organisation.
‘The combination of Sistemic’s leading-edge cell therapy characterisation technology with an established leader in the field of molecular external QA 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,’ said Sistemic CEO Jim Reid.
‘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,’ he said. ‘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 said: ‘The development of smart informatics tools and suitable controls for the QA 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.’www.sistemic.co.uk www.qcmd.org