Virus and TSE Safety made simple - Live Online Case Studies and Examples Session

Virus and TSE Safety made simple - Live Online

Course No 19208

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

All times mentioned are CET.

Costs

ECA-Member*: EUR 1590,--
Non ECA Member*: EUR 1790,--
EU/GMP Inspectorates*: EUR 890,--
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 Vaccines and Biomedicines
Dr Albrecht Gröner, PathoGuard Consult
Dr Michael Ruffing, Boehringer Ingelheim Pharma
Michael Schiffer, CSL Behring

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”.
 
It is the aim of this Live Online Training 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 Live Online Training will give you a scientifically sound introduction into the field of TSE and the impact on the pharmaceutical industry.

Target Group

The Live Online Training 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.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

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 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 Aspects of Advanced Therapy Medicinal Products (ATMPs)
  • 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
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/biopharmaceutical  production.

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