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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Getting Ready for SUT X-Ray Irradiation

Biotech Research & Commercialization Solutions | Pall Corporation webinar series

Why the introduction of X-ray sterilization technology is a critical change for single-use industry, and how gamma and X-ray irradiation compare

 

The market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.

 

Join Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD of Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology.

 

You will learn more about:

 

  • Why this is a critical change for industry and the responsibilities of each stakeholder
  • Key questions to address for biomanufacturers
  • How gamma and X-ray irradiation compare
  • What testing has been completed and key milestones for readiness for industry
  • An example of how to qualify a SUS sterilized with X-ray irradiation
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