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

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.

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

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March 2021
Case Study: Swissfillon’s Approach to Single-Use Formulation & Filling

Biotech | Pall Corporation 웨비나 시리즈

In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.

Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.

During this case-study webinar, participants will learn:

  1. How working in partnership with a supplier can be part of a QbD approach to minimize risk
  2. Strategies & design improvements for single-use systems to reduce risk in the process
  3. How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple
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