© biolution GmbH 2019
A new type of medicines emerged in the 1980s exploiting biotechnological production methods, which are referred to as biologicals. Biologicals are natural products produced and purified from natural resources, but in practice many are proteins either purified from blood like Factor VIII or antibodies produced in cell culture. Already, they are providing real benefits for patients in a wide variety of indications. One of the fastest growing classes of therapeutic compounds, biologics are outpacing the growth of small-molecule drugs.
Factor VIII deficiency is the most common cause of hemophilia, which is treated with purified protein. But some patients develop anti-drug antibodies (ADA) a frequent complication for the new therapeutics based on a biological. Therefore regulators require a detailed assessment of the antigenicity and immune response of biologicals, which is a particular strength of Krems-Bioanalytics, highlighted on their new website designed and produced by biolution.