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Virus Safety and NGS
11 November 2020
Become part of the PharmaLab Congress 2020 – as a Speaker
Please complete our online form. The deadline for submissions is 15 April 2020.
In this track the current developments, both on a regulatory and scientific level, will be presented. Authorities, system providers and users present their experiences and expectations in detecting virus contamination with the available methods, talk about the pros and cons of implementing such methods and about the possibilities of modern methods such as NGS.
For active ingredients, starting materials and drug products of biological origin, virus testing is a critical part of the chemistry, manufacturing and control (CMC) during development and release. Contamination with viruses poses a financial risk for the biopharmaceutical manufacturer in addition to the danger to life and health of the patient. Therefore, such products are tested for virus contamination or unidentifiable contamination. This poses several challenges for the pharmaceutical manufacturer:
Effects such as globalisation and climate change are causing the spread of viruses that in the past were not relevant in all regions of the world - from West Nile virus to dengue fever and Zika virus.
Conventional assays often show weaknesses in detecting low contamination levels of viruses or their components or non-targeted contaminants. There is a risk that viruses remain undetected in cell substrates, raw materials and other starting materials of biological origin.
Advanced analytical methods such as Next Generation Sequencing require extensive testing and validation before they can serve as a replacement for conventional methods.
This conference track is directed to responsible personnel involved in the development and production of biopharmaceuticals and biologics:
- Research & Development
- Quality Assurance
- Regulatory Affairs
- Quality Control