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
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
Biotech | 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