Regulatory Aspects of Connected and/or Continuous Downstream Processing – Lessons Learned
Bioprocess technologies for process intensification and continuous processing are available for essentially every step in a fully integrated bioprocessing platform. Last year, the first implementations in cGMP manufacturing environments were established for (partially) integrated continuous or intensified biomanufacturing processes. In this presentation, we will address some of the lessons learned during these implementations. In particular, we will focus on the regulatory expectations related to connected and/or continuous downstream processing unit operations.
These regulatory aspects include the challenges related to process development following the Quality by Design principles. Adequate development strategies will be discussed for critical unit operations and their translation into a control strategy in a fully integrated biomanufacturing platform will be reviewed. Other critical aspects in the regulatory framework relate to patient safety. In this context, particularly the strategies fro bioburden control and virus safety will be addressed.
Director SLS - Integrated Process Solutions
Within Pall Biotech, Marc is responsible for all field support activities related to continuous bioprocessing. In addition to this, he is leading the development of the regulatory support initiative for continuous bioprocessing within Pall Biotech.