The pharmaceutical industry has increasingly been using single-use systems (SUS) for the bioprocessing and storage of intermediate and final bulk material in addition to primary packaging. Before a SUS can be used in the manufacturing process, it needs to be qualified for use by a pre-determined process. This presentation will discuss a variety of challenges, both internal and external to the industry, that the end user faces during the qualification process. The complexity of SUS, the varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges and the potential impact of unexpected E&L study results will be discussed.
Date/Time: 14 January 2019 | 14:45 pm GMT
Dr. Ben Jeyaretnam, E&L Analytics Lead at Sanofi
Dr. Andreas Nixdorf, Team Manager/Business Development Manager, R&D at SGS