Virus and TSE Safety made simple All you need to know

Virus and TSE Safety made simple

Heidelberg, Germany

Course No 20354

This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager". Learn more.

 

Costs

ECA-Member*: EUR 1590,--
Non ECA Member*: EUR 1790,--
EU/GMP Inspectorates*: EUR 895,--
APIC Member Discount*: EUR 1690,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

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 for Vaccines and Biomedicines, Germany
Dr Albrecht Gröner, PathoGuard Consult, Germany
Dr Michael Ruffing, Boehringer Ingelheim Pharma, Germany
Michael Schiffer, CSL Behring, Switzerland

Objectives

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.

Background

The current situation has shown us that the development and production of vaccines can also attract enormous public attention. This makes it all the more important, especially when it comes to approval and production under time pressure, that the quality standards of good manufacturing practice are observed.

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”.

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 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.

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
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

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