Michael Schiffer
CSL Behring
Referent:innen
All times mentioned are CET
Zielsetzung
The course aims to explain the complex nature of viruses that move between the concepts of life and death. It provides participants with a fundamental understanding of viral and pathogen safety in the pharmaceutical industry. Participants will acquire basic knowledge of virology, including the physiology of viruses, their replication cycles, transmission routes and resistance mechanisms. This knowledge is essential for risk assessment and the development of safety strategies.
In addition, the programme teaches advanced safety strategies for dealing with viruses and testing methods, including NGS (next generation sequencing) and other modern diagnostic methods. Participants will learn best practices for viral inactivation and validation to ensure products meet industry requirements and global regulatory frameworks such as ICH Q5A, the European Medicines Agency (EMA) and the European Pharmacopoeia.
The course also provides practical insights into the control of viral contamination, including risk mitigation strategies through facility segregation, risk analysis and contamination risk management. Finally, advanced virus detection methods, including NGS, and safety-related aspects of Advanced Therapy Medicinal Products (ATMP), such as gene and cell-based therapies, will be highlighted.
In addition, the programme teaches advanced safety strategies for dealing with viruses and testing methods, including NGS (next generation sequencing) and other modern diagnostic methods. Participants will learn best practices for viral inactivation and validation to ensure products meet industry requirements and global regulatory frameworks such as ICH Q5A, the European Medicines Agency (EMA) and the European Pharmacopoeia.
The course also provides practical insights into the control of viral contamination, including risk mitigation strategies through facility segregation, risk analysis and contamination risk management. Finally, advanced virus detection methods, including NGS, and safety-related aspects of Advanced Therapy Medicinal Products (ATMP), such as gene and cell-based therapies, will be highlighted.
Hintergrund
The past 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”.
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”.
Zielgruppe
This 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.
Date / Technical Requirements / Presentations / Certificate
Date of the Live Online Training
Tuesday, 18 February 2025 08.00 - 17.30 h (CET)
Wednesday, 19 February 2025, 08.00 - 16.30 h (CET)
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Elemental (basic) Virology
- Physiology (if you can use such a word)
- Replication cycles
- Vectors
- Resistance properties
Virus Safety Strategy: Approaches and Test Procedures
- Viral safety approach: Regulations and principles
- Virus testing concept
- Methods for detection of exogenous & endogenous virus
Virus Management: Methods for Inactivation and Validation Studies in Adventitious Virus Management
- Virus contamination of starting material for biologicals
- Dedicated virus reduction steps vs. manufacturing steps for protein purification and concentration
- Down scaling of manufacturing steps for virus clearance studies
- Virus clearance studies
- Virus spike preparation
- Controls as cytotoxicity / interference / balance /inctivation kinetic
- Virus detection methods – infectivity vs. NAT
- Robustness of virus reduction methods / DoE studies
Virus Safety: Regulatory Background
- ICH Guidelines (ICH Q5A)
- European Guidelines (EMEA)
- European Pharmacopoeia
- Risk assessment
- Clinical trials in Europe
Virus Contamination Control in pharmaceutical Production
- Adventitious agents contamination control strategies
- Facility segregation & risk Analysis
- Methods of risk assessment and minimization
- Case studies
Pathogen Safety Risk Management
- Strategies for ensuring product quality and safety
- What to consider and how to perform risk assessments regarding pathogen safety
- Deviations and change management
- Case studies
Next Generation Sequencing (NGS) - a powerful Technology for Virus Detection
- Technology & applications
- Regulations, e.g., in ICH Q5A & Ph. Eur.
Virus-based Advanced Therapy Medicinal Products (ATMPs)
- Applications
- Oncolytic viruses: Mode of action & adventitious virus safety approach
- AAV - efficient gene therapy vector
- Production of AAV for gene therapy
- Quality Control of AAV
- Clinical applications of AAV
Virus Safety Aspects of Advanced Therapy Medicinal Products (ATMP)
- Regulatory background/certification
- Gene therapy medicinal products
- Cell based medicinal products
Transmissible Spongiform Encephalopathy (TSE) – Biology & Regulatory
- Nature and transmission of TSE Agent
- TSE agent detection Methods
- Prion reduction Methods
- EU legislation / EMA note for guidance / reflection paper
- EDQM TSE Certification
Interactive Workshops with Case Studies and Examples
During these workshops, the participants develop approaches to manufacture pathogen safe products, e.g. choosing testing strategies and calculating safety margins.
Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..
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Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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