Viral Safety for Biologics
TBC, live online training
This three-day training course provides an in-depth analysis of scientific and regulatory challenges connected to viral clearance evaluation and characterization studies. Topics from virus safety of raw materials to critical process parameters for virus removal and inactivation during the manufacturing of Biotherapeutics will be thoroughly covered.
- Select the correct model viruses for the clearance studies
- Get insights into important regulatory guidelines and requirements for market applications
- Background of tests for the characterization of cell lines
- Inactivate & remove viruses during downstream processes
- Conduct a viral clearance study from study plan, interaction with CRO to the final validation report
- Select the correct down scale model for the different clearance steps
- Prepare the validation studies into required regulatory documents
- Sources and types of virus contamination
- Virus safety regulatory background
- Techniques for virus inactivation and removal in the Downstream Process
- Viral clearance studies for clinical trials material in EU and US
- Virus clearance studies for market authorization
- Evaluation and characterization of viral clearance procedures
- Limitations of virus validation studies
Who should attend?
Process development, Downstream development, Downstream production managers and scientists, QA and QC managers and personnel, Regulatory affairs managers
- Senior Process Development Scientist, Merck
- QC Product Coordinator Live Viral Vaccines, GSK
- MSAT Process Scientist, Lonza
- Development Team Lead, AGC Biologics
- Associate Scientist, Amgen
- USP Cell Culture Plant Team Leader, Polpharma Biologics
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 30 days
- Digital and LinkedIn certificates
Franz Nothelfer is currently a professional consultant for downstream processing and viral safety. Before his retirement in 2017, he was heading a position as associate director Protein Science at Boehringer Ingelheim Pharma GmbH & Co. KG.
Dr. Hans Rogl is a Biochemist by training and started his industry career as a manager of a downstream process GMP production facility at Roche Diagnostics GmbH in Penzberg, Germany.
Viral Safety for Biologics
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