Elemental (Basic) Virology
- Physiology (if you can use such a word)
- Replication cycles
- Vectors
- Resistance properties
Exogenous (Adventitious) and Endogenous Virus
- Terminology
- Viral safety approach
- Effects of virus infection on host cell
- Detection of exogenous / endogenous virus
Design and Documentation of Virus Validation Studies
- Sources
- Virus spike preparation
- Cytotoxicity/interference
- Infectivity assay or NAT assay
- Down scaling of manufacturing step
Methods for Virus Inactivation and Virus Removal
- Virus reduction by manufacturing process steps for protein purification
- Virus reduction by dedicated virus reduction steps
- Robustness of virus reduction methods
Virus Safety of Raw Materials
- Qualification of the material and its supplier
- Sourcing, testing and manufacture of raw materials
- Virus clearance studies
- Testing prior and at production of biotech product
Virus Safety Aspects of Advanced Therapy Medicinal Products (ATMP)
- Regulatory background/certification
- Gene therapy medicinal products
- Cell-based medicinal products
Pathogen Safety Risk Assessments
- What to consider and how to perform risk assessments regarding pathogen safety, incl. deviations and changes
- Introduction into Segregation Risk Analysis
- Case studies
Virus Safety: Regulatory Background
- ICH Guidelines (ICH Q5A)
- European Guidelines (EMEA)
- European Pharmacopoeia
- Risk assessment
- Clinical trials in Europe
Transmissible Spongiform Encephalopathy (TSE) - Biology
- The nature and transmission of TSE agents (prions)
- Epidemiology
- Methods for detecting TSE agents
- Resistance/inactivation of prions, cleaning/disinfection
- Prion reduction techniques
Transmissible Spongiform Encephalopathy (TSE) - Regulatory
- EU Legislation (food, medicinal products, medicinal devices)
- EMEA TSE note for guidance
- EDQM TSE Certification Procedure
- Regulations for blood and urine derived medicinal products
Interactive Workshops with Case Studies and Examples
During this workshop, the participants develop in small groups approaches to manufacture pathogen safe products, e.g. choosing testing strategies and calculating safety margins.