‘Sterility Testing of Blood Components and Advanced Therapy Medicinal Products’ (Munich April 29 2010) Organized by the DGTI Section ‘Safety in Hemotherapy’ - Meeting Report

摘要

Neither screening method completely detects all clinically relevant bacterial contaminations. The effect of sampling time and volume as well as standardization of the assay applied has also to be taken into account. Therefore, minimizing the risk of contamination during manufacture by measures such as donor selection, skin disinfection, division, and processing within closed systems remains crucial. In this context new concepts in sterility testing, especially with instable advanced therapy medicinal products (ATMPs), are needed as well as reassessment of pathogen inactivation techniques. At present hemovigilance data indicate that shortening the shelf life of platelet concentrates as introduced in Germany 2008 reduced the risk of transfusion-transmitted bacterial infections to the same extent as bacterial screening as done in Canada or the Netherlands. The evolving methodological progress, e.g. by standardizing culture methods or enhancing detection systems, requires careful follow-up in parallel to hemovigilance data in order to ensure optimal bacterial safety in hemotherapy.