assay ready cells in bioassays for biologics quality control
To control the quality of a therapeutic protein, antibody, or vaccine the potency of each manufactured batch has to be confirmed. Mostly, a cell-based assay is developed and validated for this purpose. The bioassay needs to be robust and must deliver precise results at different testing sites - even after years. So, the standardization of cell culture conditions over time and across different laboratories is one of the biggest challenges.
With the use of Assay Ready Cells this challenge is overcome. acCELLerate prepares homogenous ready-to-use cell banks of up to 1.000 vials. A proper storge provided, a reliable performance of the Assay Ready Cells can be maintained for many years. All testing labs can get access to the same batch of cells which helps to improve inter-laboratory precision.
Although, analytical cell banks per definition do not need to be prepared under GMP, Assay Ready Cells are provided with a comprehensive productions batch record and certificate of analysis.
acCELLerate collaborates with multiple suppliers of bioassay cell lines and demonstrated the advantage of Assay Ready Cells for many types of potency bioassays.