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Our state-of-the-art microbiology, biochemistry and analytical chemistry labs offer certified analytical methods for protein characterization.
A product-specific set of bioanalytical procedures is developed for each product to monitor critical control points during the process and to comprehensively characterize the end product.
We follow GMP guidelines and meet the regulatory authorities’ requirements for the analytical determination of protein actives’ general characteristics, molecular structure determination, identity, activity, purity and safety, as well as the stability of the produced therapeutic proteins during product characterization and process validation.
In our biochemical and microbial quality control labs, we carry out the required analysis to secure our GMP standards for raw materials, water and environmental control.