Our GMP accredited quality control testing facilities are fully equipped to optimise and validate the analytical methods required to demonstrate the identity, safety, stability, purity and in-vitro potency of your cell-based products.
Identity and purity of the cell population can be assessed by various analytical methods, including flow cytometry and qPCR, employing the latest tools and scientific techniques to monitor product quality. Automated or manual cell counting can be performed and population doubling measurements can be used to demonstrate cell growth characteristics. Comprehensive safety testing can also be arranged, including endotoxin, mycoplasma and sterility, with rapid in-process methodologies being available for quick turnaround analysis at critical control points. All assays can be qualified according to the relevant EP and USP methodologies using representative media matrices.
The measurement of the main cellular functions, including viability, self renewal and differentiation are pivotal to the quality, function and stability of the product. These key characteristics can be monitored during processing and for final product release using appropriate technology (e.g. gene expression profiles by microarrays, flow cytometric immuno-fluorescent analysis, PCR etc). Pre- and post- thaw analysis can be undertaken to assess the suitability of the final product formulation and controlled rate freezing profile for frozen products. Stability studies can be designed and set-up to provide evidence to support the assignation of product shelf-life and for any intended extension of shelf life following initial specification.
Analytical assays can be validated according to the relevant clinical stage of development, and can include assessment of assay specificity, accuracy, reproducibility, precision, linearity and range. Batch Certificates of Analysis will be generated for all testing, providing a comprehensive package of analytical testing results to support product batch release. RoslinCT partners with qualified service providers for specialist testing, including sterility, phenotyping, karyology and viral screening to support final product release or cell bank deposition.