RESUMO
In order to assess the safety of a biological drug, a variety of factors have to be examined and then brought into an overall context considering the specific aspects of each individual product. Quoting Trasylol, the aprotinin (CAS 9087-70-1) drug extracted from bovine lungs as an example for such an approach, the complete procedure is discussed. The rationale of a safety concept, its implementation including safety related validation studies, and the combinatorial evaluation of results from these validations with underlying specificities for manufacture allow for an overall safety assessment. Validation of the removal/inactivation capacity of the manufacturing process for bovine spongiform encephalopathy (BSE) and various viruses showed high reduction potentials. These results constitute the cornerstone for the conclusion that Trasylol is safe with regard to BSE and viruses.
