Integrity Assurance for Single-Use Systems: End-User Perspective


14th March 2019 | 10AM CET / 9AM GMT | Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scientific |BOOK FREE SEAT

Single Use technologies are more and more used close to final product leading to increasing concern related to integrity. In this article, we would like to share supportive data affecting integrity. Defect mode analysis has allowed us to build a risk assessment and a strategy on integrity. This strategy is very important for critical applications when single use are used after last sterile filtration or in a process no sterile filtration is possible.
Several case studies supporting our approach will be shared showing the importance of addressing integrity in the context of use and taking all technical aspect into consideration.

Presented by Charlotte Masy, Project Manager in global support GSK vaccinés

Charlotte Masy is BioEngineer with a PhD in material science in surface chemistry. She has done her career in material science spending 20 years working on the investigation, research and services for all sectors but mainly for pharmaceutical products at Solvay, Ajinomoto, Pall and GSK vaccines. She has 15 years of experience in cGMP in various positions including QC, QA and Engineering. She is expert Single Use at GSK Vaccines since 2010 and working on integrity test for 5 years.

 

 

 

Sponsored by Thermo Fisher Scientific

Thermo Fisher Scientific supports developers and manufacturers of biological-based therapeutics and vaccines with a world-class product portfolio that spans the bioprocessing workflow from discovery through large-scale commercial production. Starting with production-grade raw materials and supply chain logistics, we provide solutions and services across the manufacturing value stream and through QC release of finished goods, including upstream cell culture, downstream purification, analytical and QC testing, end-to-end single-use technologies, and comprehensive measurement and control solutions.

Presented By Donald Young, Sr. Product Manager at Thermo Fisher Scientific

Donald Young is the Product Manager for BioProcess Containers, at Thermo Fisher’s BioProduction Division facility in Logan, Utah. He has a Bachelor of Arts degree in Biology and a Master of Science degree in Public Health.   Don has 10 years’ experience as a product manager. Don started his career as a laboratory technician specializing in cell culture and joined Thermo Fisher after working as a medical science liaison at Abbott Laboratories and Merck, Sharp and Dohme for 12 years. Don’s management of BioProcess Containers entails participation on cross-functional teams that manage change control, pricing, supply chain, film portfolio, training, product customization, and component library maintenance.

 

 

 


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