quality

The quality of cells is essential for the reliability and reproducibility of a bioassay. However, the cultivation of cells requires special expertise and thorough handling and care. Otherwise the integrity of the cells and their phenotypic characteristics are hard to maintain.

At acCELLerate we use standardized procedures and perform diligent controls to ensure a high quality of all cells and cell based kits we provide. We have established a quality management system which has been certified according to ISO 9001:2008 and which comprises all relevant areas such as material supply, human resources, environmental control, product development, manufacturing, quality control, storage, distribution, and customer support.

acCELLerate obtains its cell lines from a reliable source of a private German cell depository and uses STR analysis, species PCR and cell type specific markers to control the identity of the cells. A strict regime of master and working cell banks is used to control the origin and the population age of each batch of cells. All cell banks are stored in vapor phase of liquid nitrogen. During cell expansion passage number, population doublings, cell growth, viability, amount of debris, and cell morphology as well as phenotypic markers are documented. acCELLerate uses certified serum, media and consumables from reliable vendors only. The cell cultures are frequently tested by PCR for the absence of mycoplasma. No prophylactic antibiotics are used to avoid cached contaminations.

The access to acCELLerate’s laboratories is restricted to authorized and trained personnel. The production environment is carefully maintained and monitored to meet our hygiene requirements. All production and QC equipment has been qualified. Physical parameters of cell culture incubators (temp, CO2, humidity), freezers (temp), and liN2 storage (temp, filling level) are online controlled and documented.

For batch release 5% of all vials of cells will be checked to match our quality specifications for cell count, homogeneity, viability, amount of debris, morphology, assay performance and of course the absence of any contamination.

To comply with the special requirement for cells which are used in bioassays under GMP or equivalent regulations, all procedures, all material which is used, and the data of all controls which have been performed are carefully documented. A complete GMP-compliant batch record is provided upon request.