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.

Speaker

Marc Bisschops

 

Director SLS - Integrated Process Solutions

Pall Biotech

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.

Biography

Regulatory Aspects of Connected and/or Continuous Downstream Processing – Lessons Learned

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October 2021

Integrity Assurance for Single-Use Systems An End-User’s Perspective

 

What should you consider when building an integrity control strategy for your single-use systems (SUS)? How do you overcome application challenges?

 

Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective. They will present several case studies to show how integrity concerns can be practically addressed for cGMP manufacturing applications and the results observed a few years on. 

 

Attendees will learn about:

 

  • The latest regulatory requirements for integrity assurance of SUS
  • The different technologies available to control integrity of SUS
  • Key parameters that affect integrity measurements

 

Register now for this webinar from industry experts on October 6.

 

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