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
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
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
- Facility segregation to avoid cross-contamination of product intermediates
Virus Safety Aspects of Advanced Therapy Medicinal Products (ATMPs)
Regulatory background/certification
Gene therapy medicinal products
Cell-based medicinal products
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
Case Studies and Examples for Assessing Approaches to Manufacture Pathogen Safe Products
In this section of the training all trainers will use case studies and examples to show you different approaches to dealing with problems in vaccine/niopharmaceutical production.