In-House Training
when developing a process for the manufacture of therapeutical recombinant proteins expressed in mammalian cell lines, gene therapy and cell therapy products, the biotherapeutics should not generate a risk of viral contamination of the patients. In the past, there were cases of viral contaminations that had tremendous safety, supply and financial impacts.
Regulatory agencies expect then that the manufacturing processes are appropriately designed to incorporate steps able to remove and/or inactivate viruses that may have been unexpectedly introduced into the process. But moreover, those risks should be prevented by using safe raw and starting materials, segregating the manufacturing steps and controlling the manufacturing environment.
The purpose of the Master Class is to give an overview of the sources and impacts of viral contaminations of biotherapeutics, how to prevent those risks and how to evaluate the capability of the process to remove and/or inactivate potential viruses through viral clearance studies.
Understand the consequences linked to a contamination of mammalian cell cultures and biologicals with unexpected viruses from experiences reported by the bioindustry
Understand the regulatory expectation on preventing the risks of viral contaminations
How to prevent the risk of biotherapeutics to be contaminated with adventitious viruses?
Propose methods to build up a process with an adequate capability to remove /inactivate potential viruses
How to demonstrate the capability of the process to remove / inactivate viruses?
Process development scientists and managers
CMC development program managers
Manufacturing managers
Heads of Quality assurance
Drug Regulatory Affairs managers
Set the Scene
Risk and impact of viral contamination in the biotech industry
Biology of viruses
Reported events
sources of contamination
Impacts of viral contamination
Case studies
Lessons learnt
Regulatory Considerations
source documentation
On-going revision of ICH Q5a(R2)
Recombinant proteins / Gene therapies / Cell therapies
Risk prevention
source of raw materials, prevention and testing
Cell bank testing
Testing of process intermediates
environmental control
Personnel control
segregation of manufacturing activities
Closed processes
Impact of COVID pandemics
Viral clearance studies
What to deliver and by when?
Virus inactivation / removal
Methods of virus inactivation
Methods of virus removal
Orthogonality
scale-down models
Model viruses
Pre-requisites to spiking studies
spiking studies
Testing methods
New and aged chromatography resins
VLP quantification
Overall process capability to remove / inactivate viruses
Specificities of continuous manufacturing
Questions & Answers
Please contact us at mylene.talabardon@biotechnologyconsultant.com