Viral Inactivation Validation of Lipoprotein Process
| Project start date: | 28 August 2006 |
| Project end date: | 30 June 2007 |
| Publication date: | 01 June 2007 |
| Project status: | Completed |
| Livestock species: | Sheep, Goat, Lamb, Grassfed cattle, Grainfed cattle |
| Relevant regions: | National |
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Summary
Selborne Biological Services (SBS) and MLA developed a lipoprotein cell culture media supplement, LipiMAX which is extracted from adult bovine blood sourced from abattoirs in Australia.
In order to demonstrate the safety of pharmaceutical proteins derived from biological sources it was mandatory for the manufacturer of such products to demonstrate the effective inactivation and/or removal of pathogenic viruses during the manufacturing process. Usually, this is done by the deliberate spiking of a down-scaled version of the manufacturing process with relevant and/or model viruses.
The purpose of study under P.PSH.0218 was to test for the effectiveness of heat treatment to inactivate viruses during the manufacturing process of a Lipoprotein. The appropriate model virus for this process is BVDV, an enveloped RNA Flavivirus.
Outcomes
LIPIMAX has been successfully commercialised.
More information
| Project manager: | Antoine Valterio |
| Primary researcher: | New Lab BioQuality GmbH |
