The new controls aim to improve reproducibility and eliminate variability in clinical diagnostics and cell therapy manufacturing.
Amsbio has launched a range of synthetic cell mimic products designed to eliminate the variability, fragility, and operational inefficiency inherent in traditional flow cytometry biological and polystyrene bead controls.
Researchers in pharmaceutical companies, biotechnology firms, contract research organizations, clinical diagnostics, and academic centers have sought access to mass-produced cell mimics that contain rare biomarkers and are stable over the long term for the development of targeted therapies, according to Amsbio.
The new synthetic cell-mimic controls offer lot-to-lot consistency with coefficients of variation as low as 0.1%. This level of consistency allows researchers to achieve reproducible results across multiple sites and instruments, which is a requirement for clinical trials, cell therapy manufacturing, and regulatory submissions, the company says in a release.
For laboratory teams running flow cytometry assays across various instruments, operators, and sites, the cell-mimic controls deliver biology-like behavior without the variability of donor peripheral blood mononuclear cells. The products also remove the safety burden of biohazardous materials and the maintenance overhead associated with cell lines.
These mimics help researchers standardize workflows, tighten assay performance, and reduce bridging studies, according to the company. The synthetic cell mimics offer an extended shelf life with no maintenance required and are fully customizable with biomarkers, proteins, and fluorescence.
Photo caption:Â Precision-engineered cell mimics
Photo credit: Amsbio