Virus and TSE Safety made simple
Im Auftrag der ECA Academy

7-8 March 2019

Heidelberg, Germany

Seminar Nr. 16930

Unser Seminarservice

Kosten

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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Johannes Blümel, Paul-Ehrlich-Institut, Federal Agency Vaccines and Biomedicines

Dr Albrecht Gröner, PathoGuard Consult

Dr Michael Ruffing, Boehringer Ingelheim Pharma

Hintergrund

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.

Zielgruppe

The Education Course is directed to responsible personnel involved in the development and production of biopharmaceuticals and biologics

Research & Development
Quality Assurance
Regulatory Affairs
Production
Engineering
Quality Control

It is also useful for service providers, such as contract research organisations and contract manufacturers.

Interactive workshop

During this workshop, the participants develop in small groups approaches to manufacture pathogen safe products, e.g. choosing testing strategies and calculating safety margins.

Programm

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 ste

p
Techniques 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 advanced therapy medicinal products

Regulatory background/certification
Gene therapy medicinal products
Cell based medicinal products

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

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Virus and TSE Safety made simpleIm Auftrag der ECA Academy