Dr Johannes Blümel, Paul-Ehrlich-Institut, Federal Agency Vaccines and Biomedicines
Dr Albrecht Gröner, PathoGuard Consult
Dr Michael Ruffing, Boehringer Ingelheim Pharma
Virus safety is one of the major concerns in the development and production of biopharmaceuticals and biologics. Huge efforts are undertaken to prevent viral contamination. A series of guidelines was dedicated to that topic exclusively.
For many people who are involved in the development and production of biopharmaceuticals and biologics the world of viruses is a "black box".
It is the aim of this course to enlighten this world between "dead and alive".
The nature of viruses postulates significant differences to micro-organisms. This uniqueness poses particular challenges to the detection, inactivation and removal of viruses.
All these specifics will be discussed in detail at this education course - in an understandable manner.
Another threat poses TSE (Transmissible spongiform encephalopathy). Numerous studies have been conducted to understand the route of transmission and the causing agents better. Nevertheless, misunderstandings and rumours circulate and cumulate in the statement: "We need a TSE-certificate for our activated charcoal."
This course will give you a scientifically sound introduction into the field of TSE and the impact on the pharmaceutical industry.
The Education Course is directed to responsible personnel involved in the development and production of biopharmaceuticals and biologics
- Research & Development
- Quality Assurance
- Regulatory Affairs
- Quality Control
It is also useful for service providers, such as contract research organisations and contract manufacturers.
During this workshop, the participants develop in small groups approaches to manufacture pathogen safe products, e.g. choosing testing strategies and calculating safety margins.
Elemental (basic) virology
Exogenous (adventitious) and endogenous virus
- Physiology (if you can use such a word)
- Replication cycles
- Resistance properties
Virus Safety of Raw Materials
- Viral safety approach
- Effects of virus infection on host cell
- Detection of exogenous / endogenous virus
Design and Documentation of Virus Validation Studies
- 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 spike preparation
- Infectivity assay or NAT assay
- Down scaling of manufacturing ste
Techniques for Virus Inactivation and Virus Removal
Virus safety of advanced therapy medicinal products
- Virus reduction by manufacturing process steps for protein purification
- Virus reduction by dedicated virus reduction steps
- Robustness of virus reduction methods
- Regulatory background/certification
- Gene therapy medicinal products
- Cell based medicinal products
Transmissible spongiform encephalopathy (TSE) - Biology
- ICH Guidelines (ICH Q5A)
- European Guidelines (EMEA)
- European Pharmacopoeia
- Risk assessment
- Clinical trials in Europe
Transmissible spongiform encephalopathy (TSE) - Regulatory
- The nature and transmission of TSE-agents (prions)
- Methods for detecting TSE agents
- Resistance/inactivation of prions, cleaning/disinfection
- Prion reduction techniques
- EU-Legislation (food, medicinal products, medicinal devices)
- EMEA TSE note for guidance
- EDQM TSE Certification Procedure
- Regulations for blood and urine derived medicinal products