Virus clearance studies are performed to ensure that the purification process has sufficient capability to remove and/or inactivate any viruses that may possibly contaminate the starting material. Selected steps are tested against a panel of viruses, including both enveloped and non-enveloped. It is typically more difficult to show viral clearance for non-enveloped viruses than enveloped viruses because of their smaller size and their relative resistance to physical-chemical inactivation. For these reasons, there is a need for an effective inactivation procedure for non-enveloped viruses.
UV-C treatment has been evaluated in the past for viral inactivation, but recent improvements in the technology have made it practical to use for the first time. Adding this step to a manufacturing process can provide an additional option for viral clearance for products where it is difficult to show adequate clearance. In addition, manufacturers planning to simplify their purification process may find this method beneficial as a means to maintain a sufficient viral clearance level with fewer purification steps.
During this presentation you will learn:
- Design and function of the UVivatec instrument
- Effectiveness of UV-C for inactivation of a number of different viruses in different virus families
- Impact of UV-C irradiation on the product
- How to integrate this technology into a manufacturing process
- Results from a case study detailing the use of UVC as a solution to viral inactivation when other techniques failed for a virus-like-particle vaccine.
Katherine Bergmann, Ph.D., Manager, Viral Safety and Viral Clearance Services, Eurofins Lancaster Laboratories
Katherine Bergmann, Ph.D, is manager of Viral Safety and Viral Clearance Services at Eurofins Lancaster Laboratories. She has extensive experience in cell line characterization, lot release testing and viral/TSE clearance validation and has numerous publications and presentations in the field. She has performed biomedical research in protein chemistry, cell biology and virology at Georgetown University, Scripps Research Institute and Rockefeller University. She received a Ph.D. from Brown University and a A.B. degree from Mount Holyoke College. Dr. Bergmann served on the PDA task force on Preparation of Virus Spikes Used for Virus Clearance Studies.
Dr. Todd Talarico, Vice President of Manufacturing, Medicago
Todd Talarico is Vice President of Manufacturing for Medicago and oversees the US and Canadian development and manufacturing operations. He has been responsible for Medicago-USA’s completion of an aggressive design-build project resulting in rapid construction and deployment of a facility designed to produce more than 10 million doses (in 30 days) of H1N1 vaccine expressed in and purified from tobacco plants.
Todd received a BS in Chemical Engineering from the Pennsylvania State University and a Ph.D. in Microbiology from North Carolina State University. He completed postdoctoral work at Burroughs Wellcome studying protein translocation and purification. Todd was the Director of Product Development at Apex Bioscience where he was responsible for a team that brought a PEGylated hemoglobin molecule from development to Phase III clinical trials.
He began working in the vaccine field with AlphaVax where he was a Senior Director responsible for development and process scale up of a virus replicon particle vaccine. While at AlphaVax, he was part of the team that delivered vaccines for colon/prostate cancer (CEA and PSMA), Her-2, Flu, CMV and HIV into clinical trials.
Sherri Dolan, Field Marketing Manager, Virus Clearance Technologies, Sartorius Stedim North America
Sherri Dolan has been at Sartorius Stedim North America, in the Purification Technologies Group, since 2005. Her responsibilities as Field Marketing Manager include supporting small virus removal membranes, membrane adsorbers and UVC technology. Throughout the past +25 years, she has held a wide variety of positions in the BioPharmaceutical industry, in both large Pharmaceutical and small biotech companies. With a focus on downstream purification, her previous positions range from R&D, process development, clinical manufacturing, field application support in the areas of cell culture clarification, chromatography, filtration (TFF, prefiltration, sterile and virus removal filtration) and final filling operations.
Who Should Attend?
Directors and Managers in a Biopharmaceutical company who are responsible for the following aspects of product development:
- Process Development
- Quality Control
Euofins Lancaster Laboratories
With a proven track record of providing quality scientific solutions for 19 of the top 20 largest Pharmaceutical/bioPharmaceutical companies in the world, Eurofins Lancaster Laboratories is a global leader in bio/Pharmaceutical laboratory services providing innovative and timely scientific solutions to streamline the drug development process.
With facilities in Lancaster, PA, Portage, MI and Dungarvan, County Waterford, Ireland, and a global capacity of over 400,000 square feet, Eurofins Lancaster Laboratories has the capabilities to meet your global regulatory requirements. All of our facilities offer cGMP-compliant laboratory services and operate under the same strict quality control program and utilize the same LIMS system.
Our clients can choose from five service models, including our award-winning Professional Scientific StaffingSMand our Full Time Equivalent model to determine the most efficient and cost-effective service solution for their project. We also provide 24-hour data access via our innovative and secure online tool at LabAccess.comSM.