Wednesday, November 27th, 2019
Single-use (SU) technology is without question one of the key technologies for the development of the biopharmaceutical industry and the manufacturing of drug products. SU equipment is used especially for scalable application such as the production of vaccines, CAR T cells, monoclonal antibodies (mAb), or the manufacturing of biosimilars. One of the main concerns over the last decades continues to be extractables from SUS which potentially are released into the process solutions as process equipment-related leachables (PERLs). In this context, the assessment of extractables is required for the process qualification.
The webinar focuses on the strategy developed by Sartorius Stedim Biotech (SSB) to provide the most detailed extractables data enabling our customers to implement rapidly and cost-effectively SU equipment into bioprocessing applications. The analytical and component approach is presented. Scaling exercises and the toxicological evaluation is exemplified using data of the current SSB Extractable Guide of a widely-used sterile filter of the Sartopore® family.