The Goettingen, Germany-headquartered bioprocessing tech firm launched Virosart Media for virus retention in cell culture media this week, offering what it says is a fast and cost-effective way to reduce the risk of virus contamination during the fermentation process.
“Normally, virus filters are not used in upstream processes,” Birte Kleindienst, a Sartorius Stedim Biotech viral clearance expert, told Biopharma-Reporter.com. “In the past, if customers decided to be proactive in minimising their production risk, they had only two alternatives available: downstream virus filters or high-temperature short-time [HTST] processes.”
But using downstream filters in upstream applications has been problematic for drugmakers as they have very low flow rates and are expensive.
“Our new Virosart Media product has changed all this, offering manufacturers a fast and cost-effective solution,” she continued.
The filter is designed to be used upstream of any bioreactor, whether Sartorius’s own or not, as well as in each media preparation step with different filter areas available for different size batches.
“We consider this filter a type of ‘virus insurance’ that prevents viruses from contaminating customers’ cell cultivation processes because Virosart Media filters out viruses from their cell culture media. As a result, Virosart Media saves customers from having to dispose of batches suspected of being contaminated.”
Upstream filter requirements differ from the ones for downstream filters as the slide below – provided by Sartorius – demonstrates.
“The two biggest differences are that first, downstream processing filters let the target product or proteins pass through, which is not the case for upstream processing filters; and second, both types of filter differ in their flow rates,” said Kleindienst.
And, at the moment, while there are there two key guidelines for using virus filters in the downstream process,* there is no guidance for using virus filters for virus risk mitigation in the upstream process.
“It is up to customers to be proactive in minimizing their own risk of virus contamination during their cell cultivation processes,” she added.
* EMEA/CPMP/ICH/295/95 (ICHQ5A) (1997): “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin”
EMEA/CHMP/BWP/398498/2005 (2008): “Guideline on virus safety evaluation of biotechnological investigational medicinal product