Virus and TSE Safety made simple

Virus and TSE Safety made simple

Heidelberg, Germany

Course No 16315


Costs

Non-ECA Members: EUR 1790,--
ECA Members: EUR 1590,--
EU GMP Inspectorates: EUR 895,--
APIC Members (does not include ECA Membership): EUR 1690,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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

Dr Albrecht Gröner, PathoGuard Consult

Dr Michael Ruffing, Boehringer Ingelheim Pharma

Background

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.

Target Group

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.

Programme

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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