Implementing Single Use Technologies in Sterile Vaccines Processing

Implementing Single Use Technologies in Sterile Vaccines Processing

This on-demand webinar presented by Charlotte Masy of GSK is a case study illustration of GSK’s strategic approach for sterility assurance.

One of the main challenges when considering single-use technologies in sterile vaccines manufacturing is to ensure the highest level of assurance of integrity and sterility.

 

This webinar presented by Charlotte Masy of GSK is a case study illustration of GSK’s strategic approach for sterility assurance.

 

 Topics covered:

 

  • How a Quality by Design (QbD) approach has been applied to develop, design and qualify single-use systems for vaccine manufacturing
  • How GSK manage sterility assurance concerns
  • Assessing and mitigating risks to integrity of SUS in sterile applications

 

Speaker

 

 

Charlotte Masy

Charlotte Masy

 

Technical Lifecycle Project Manager 

TLCM-MSAT

GlaxoSmithKline

Learn more about the Helium Integrity Test

Manage risk in your critical process with this high sensitivity, supplier integrity test for single-use systems, filling sets and mixer biocontainers

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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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