Blood and Plasma Manufacturing: How Robust Virus Removal Techniques Can Help Prepare For The Unexpected
Sponsored by: Sartorius Stedim Biotech
- Blood And Plasma Manufacturing
Date: 10 November
Days to go: 15
Time: 3PM London/10AM New York
Perspectives For The Clearance Of Emerging Viruses
Biopharmaceutical manufacturing processes require a holistic virus safety strategy to prevent the transmission of infectious diseases by viruses. These safety concepts required by regulatory authorities are mandatory for all biopharmaceutical products derived from human or animal origins. They have to be applied at all stages of production—from clinical trials to commercial manufacturing.
Manufacturers of plasma-derived medicinal products (PDMPs) face increased challenges as the main raw material is of human origin and can therefore be contaminated with pathogens capable of causing direct infections in patients. Furthermore, routinely conducted testing on adventitious viruses is often limited to known contaminants and can easily fail on emerging and other unknown viruses. These circumstances not only present key challenges for scientists and engineers in downstream processing, but may also be of regulatory relevance.
In this webinar, we will discuss the challenges and points that need to be considered when implementing virus safety concepts and present the benefits of virus filtration when it comes to establishing effective and reliable virus clearance steps within PDMP production. Furthermore, we will highlight the importance of robust, scalable virus clearance technologies such as Virosart® HC for the removal of emerging viruses like SARS-CoV-2 in biopharmaceutical manufacturing.
Register now to reserve your spot for this exciting webinar! We look forward to welcoming you to our presentation.
Dr. Michael Lasse,
Product Manager Virus Clearance
Dr. Michael Lasse joined Sartorius Stedim Biotech in December 2019 as Product Manager Virus Clearance. He has more than 6 years of experience in the biotechnology and bioprocessing industry. Prior to joining Sartorius, he worked as Study Director for Virus Clearance studies and was a team lead focussing on chromatography and virus safety at Charles River Laboratories in Cologne, Germany.
He holds a Diploma in Biology from the University of Rostock, Germany and a PhD in Biochemistry from the University of Cologne, Germany. During his studies he worked on recombinant protein expression in various prokaryotic and eukaryotic systems and protein purification via chromatography.
Key Learning Objectives
- Gain insight into virus safety strategies and virus clearance concepts
- Understand the impact of emerging viruses on established virus safety concepts
- Learn about methods and techniques utilized in virus clearance studies for PDMPs
- Find out more about the application of virus filtration and Virosart® HC in the production of PDMPs
- Process Development Scientists
- Process Development Managers
- Process Engineers
- Engineering Directors