On May 4-6, 2021, SGS will be attending the virtual World Vaccine Congress US.
The congress offers relevant content and experts in:
- Immune profiling
- Bioprocessing and manufacturing
- Cancer and immunotherapy vaccines
- Clinical trials
- Emerging and re-emerging diseases
- Influenza and respiratory vaccines
- Vaccine partnerships
- Veterinary vaccines
- Vaccine safety
- Vaccine logistics
"Vaccine biosafety – how to ensure compliance with current and future global regulatory authority requirements."
Viruses replicate or grow within living organisms and therefore any biological system developed to generate biopharmaceutical products could be contaminated with viruses. Virus contamination could arise due to the presence of virus in the original cell line or biological system used, or to the inadvertent introduction of virus into cell cultures during manufacturing processes, due for example to operator error or use of raw materials of animal origin. It should be noted that there are several well-documented historical instances of virus transmission to humans through contaminated vaccines and biologics.
A key aspect of biologics development requires consideration and compliance with the current regulatory authority guidelines. Regulatory authorities require testing to be carried out at every stage of the manufacturing process of the product including cell substrate banks, viral seed banks, raw materials of animal origin, bulk harvests and batches of the final manufactured clinical product. The samples must be tested to recognized international guidelines such as International council for Harmonization (ICH), United States Food and Drug Administration (FDA) or European Pharmacopeia (EP).
This talk will present current testing strategies and validated assay methods to ensure biosafety compliance at all stages of vaccine development and product release, and outline the application of new methods, for example next generation sequencing. SGS in Glasgow is a GMP approved testing facility offering a range of validated methods to test a wide range of cell banks and viral vaccine seeds.
Meet the team to find out more about our clinical trials services and biosafety solutions.
For further information, please contact:
t: +32 15 27 32 45