Economic Impact

Besides improving product quality LEUKOCARE’s SPS technologies also bear a significant potential to reduce production costs by replacing aseptic production by terminal sterilization.

Although the pharmacopoeias require terminal sterilization whenever possible, aseptic processing is generally considered to be state of the art for the production of therapeutic proteins, related biological macromolecules. The number of warning letters issued by the FDA addressing concerns with aseptic production and processing of biologics is increasing over the past years. LEUKOCARE’s SPS technologies overcome these limitations and to open doors towards safer and cheaper products. The cost saving potential is estimated to be in the range of > 20 % of production costs for biopharmaceuticals and up to 75 % for production costs of biologic-device combination products.