We developed an internal quality control system to guarantee a high quality of our products for the long-term stability. This system, as well as our products, is being constantly improved. Our yeast-based biosensors are cultivated under controlled and standardized conditions in a bioreactor where the yeast cells are harvested and subsequently freeze dried. Quality tests are performed on every batch of cells according to the specific criteria in order to assess its robustness and sensitivity. Batches of biosensors that do not meet our standards are withdrawn from the production. Tests for the long-term stability of the biosensors of each batch also reveal information regarding the competency of our yeasts stored in different conditions.
We are supported by our partner QuoData GmbH, which has a great expertise in the field of method validation. All of our methods are validated for their corresponding applications. For instance, the A-YES® has been validated in compliance with the ISO standardization process in an international interlaboratory trial. All other test methods are carried out by in-house factorial validation studies that simultaneously vary a number of interdependent factors, such as sample types and incubation conditions, etc. The validity of a test after optimization is confirmed by an equivalence test with the standard reference methods.
In regards to the analytical services of our laboratory, we aim for fulfilling the requirements of DIN EN ISO/IEC 17025. Every procedure that is part of our analytical services is explicitly described and well-documented. Pipettes, lab equipment, along with other instruments, are routinely calibrated or certified in definite time intervals. Customers will also receive the information on the measurement uncertainty of results within the test report.