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Viral Safety for Biological Drug Products
Viral Safety for Biological Drug Products

Course Description

This three-day training course provides a thorough 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 biological drug products.

  • Sources and types of virus contamination
  • Virus safety regulatory background
  • Techniques for virus inactivation and removal in the Downstream Process
  • Regulatory requirements for VC studies
  • Evaluation and characterization of viral clearance procedures
  • Limitations of virus validation studies
  • Select the correct model viruses for clearance studies
  • Understand the regulatory requirements for clinical trials and marketing authorisation
  • Background of tests for the characterization of cell lines
  • Learn how to Inactivate & remove viruses during downstream processes
  • Understand the possibilities and limitations of virus clearance procedures and studies
  • Conduct a viral clearance study from study plan, interaction with CRO to the final validation report
  • Select the correct scale-down model for the different clearance steps

Viral Safety for Biological Drug Products

June 17 - 19, 2024, Live Online Training
Regular price $2,250
Unit price
per 
Dr. Albrecht Gröner

Dr. Gröner has more than 30 years or experience in the field of pathogen safety of biologicals prepared from plasma or cell cultures. He is member of several scientific societies and in the organisation committee of scientific meetings. He peer-reviews manuscripts related to pathogen safety, testing, and production of biopharmaceuticals submitted for publication.

START TIMES

7:00 AM New York time

4:00 AM Los Angeles time

12:00 PM London time

1:00 PM Vienna time

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Course Description

This three-day training course provides a thorough 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 biological drug products.

  • Sources and types of virus contamination
  • Virus safety regulatory background
  • Techniques for virus inactivation and removal in the Downstream Process
  • Regulatory requirements for VC studies
  • Evaluation and characterization of viral clearance procedures
  • Limitations of virus validation studies
  • Select the correct model viruses for clearance studies
  • Understand the regulatory requirements for clinical trials and marketing authorisation
  • Background of tests for the characterization of cell lines
  • Learn how to Inactivate & remove viruses during downstream processes
  • Understand the possibilities and limitations of virus clearance procedures and studies
  • Conduct a viral clearance study from study plan, interaction with CRO to the final validation report
  • Select the correct scale-down model for the different clearance steps

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Viral Safety for Biological Drug Products

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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