Viral Safety for Biologics

Place
Renaissance Wien Hotel, Vienna, Austria
Site visit
Dates
12 – 13 March 2020
Who should attend?

Process development, Downstream development, Downstream production managers and scientists, QA and QC managers and personnel, Regulatory affairs managers

Summary

This two-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 thoroughlycovered.

Aims

Learning & Key takeaways:

  • Select the correct model viruses for the clearance studies
  • Get insights of important regulatory guideline 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 final validation report
  • Select the correct down scale model for the different clearance steps
  • Prepare the validation studies into required regulatory documents

Key Topics

  • 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

Programme

  • Training materials will be provided in printed and digital form
  • All delegates will receive printed and LinkedIn certificates
  • 5 hours of networking with industry peers
  • Networking cocktail reception
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Trainers

Franz Nothelfer

NothelferConsulting

Downstream Processing & Viral Safety

Franz Nothelfer is currently 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. He was responsible for the development of novel purification processes for therapeutic proteins and monoclonal antibodies. His major task was the transfer, establishment and optimization of purification processes of customers to achieve robust and economic manufacturing processes. He was also responsible for the establishment of new innovative techniques in purification. From 1989 until 2003 he was conducting viral clearance studies. From 2003 until 2016 he was responsible for planning and conducting of viral clearance studies for BI internal projects and for client projects.

Franz Nothelfer

NothelferConsulting

Downstream Processing & Viral Safety

Franz Nothelfer is currently 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. He was responsible for the development of novel purification processes for therapeutic proteins and monoclonal antibodies. His major task was the transfer, establishment and optimization of purification processes of customers to achieve robust and economic manufacturing processes. He was also responsible for the establishment of new innovative techniques in purification. From 1989 until 2003 he was conducting viral clearance studies. From 2003 until 2016 he was responsible for planning and conducting of viral clearance studies for BI internal projects and for client projects.

Dr. Hans Rogl

Hoffmann-La Roche

Manager Pharma Technical Regulatory Affairs

Dr. Hans Rogl is a Biochemist by training and started his industry career as manager of a downstream process GMP production facility at Roche Diagnostics GmbH in Penzberg, Germany. In the following time he assumed roles in technical development at Roche and later as associate director at Boehringer Ingelheim Pharma GmbH & CoKG. Currently, he works as manager in technical regulatory affairs at Roche. During his career he had additional responsibilities as subject matter expert for viral safety. He has hands-on experience for conducting virus validation studies and a deep knowledge of current regulatory requirements and practises regarding viral safety.

Dr. Hans Rogl

Hoffmann-La Roche

Manager Pharma Technical Regulatory Affairs

Dr. Hans Rogl is a Biochemist by training and started his industry career as manager of a downstream process GMP production facility at Roche Diagnostics GmbH in Penzberg, Germany. In the following time he assumed roles in technical development at Roche and later as associate director at Boehringer Ingelheim Pharma GmbH & CoKG. Currently, he works as manager in technical regulatory affairs at Roche. During his career he had additional responsibilities as subject matter expert for viral safety. He has hands-on experience for conducting virus validation studies and a deep knowledge of current regulatory requirements and practises regarding viral safety.

Tour info

Testimonial

"The training provided a unique opportunity to share my own experience and to learn from the practical experience of others" - GSK

Price per Delegate (EUR)

1989.00
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Request Full Agenda

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Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543