Accelerating Vaccine Development with Standard SU Solutions while Minimizing Manufacturing Risks
The virus platforms (recombinant protein, virus, viral vector or mRNA) have raised new challenges for the implementation of single-use systems. This webinar will present how QbD and application information have been implemented for designing the SU solutions and their quality features. With the increasing need of patient and operator safety, the presentation will focus on risk analysis and mitigation action in place for standard single-use systems for storage, mixing and shipping steps. The Pre-Designed Solutions offer robust bioprocessing, reliable quality performances as well as reliable supply chain and business continuity well adapted to the needs of the different vaccines platforms.
Key Message of Webinar
- Robust single-use Development based on QbD and robust qualification plans
- Implementation of standard Pre-Designed Solutions for best quality performances with adequate services
- Application driven and robust solutions qualifications that can be leveraged by end-users for their own process validation
Key Learning Objectives
- Standardization benefits for accelerating process development for vaccine development
- Secure implementation of single-use systems for saving time in vaccine scale up manufacturing
- Criteria for defining the partner of choice with reliable Assurance of Quality Supply
Meet Our Expert
Head of Product Management Bags/Mixing/Tanks
Elisabeth Vachette is managing Product Management for Bags/Mixing/Tanks within the Single Use Fluid Management Technologies Department at Sartorius Stedim Biotech based in Aubagne, France. With a Biotechnology Engineer graduation of the ENSAIA of Nancy and 20 years of experience, Mrs. Vachette supports the biopharmaceutical industry on a world-wide basis, in particular in process design, validation, training and implementation of single-use fluid management technologies.
Since joining Sartorius Stedim Biotech in 2000, she has been responsible for quality, production, engineering and now product management providing a broad view of the functionalities of single-use solutions development, marketing, qualification and manufacturing. She is an active member of scientific committees for PDA conferences and is member of the BPSA board of directors.