BURECO offers a wide variety of cell based and biochemical assay systems and many years of broad experience based on scientific and regulatory expertise. Long-term experience with first generation biopharmaceuticals enables us to effectively support the expanding area of biosimilars and "biobetters". Developing assays from scratch followed by optimization and validation according to FDA/EU guidelines is one of our core competences. In many cases we also transfer already validated methods from our customers. During the validation process all relevant criteria like dynamic range, accuracy, precision and reproducibility, specificity, sensitivity, stability, hook effect, etc. are considered and the most meaningful data evaluation procedure will be selected. Validated assays are applied for sample analysis from small and large scale studies (toxicological, pre-clinical, clinical studies up to phase IV). The storage capacity is not limited and under remote control (7/24). The handling of huge numbers of data is guaranteed by our data management and will be customized in order to directly import the data into your LIMS. Especially in the complex field of potency assays for biopharmaceuticals, BURECO can offer its expertise by establishing and validating your assays in the requested quality according to cGMP and apply such assays in routine testing. The statistical analysis of the data is done by using validated tools considering customer’s needs. As an additional service, BURECO offers assistance and consulting for designing assays and setting up strategies including trouble shooting for your in-house applications. |
