First risk-mitigating virus-retentive filter for cell culture media
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has launched Virosart® Media for virus retention in cell culture media. With this new media filter, the company offers a fast and cost-effective solution for manufacturers to reduce the risk of virus contamination resulting from raw materials, such as chemically defined media, during fermentation.
Virosart® Media is a single-use filter that provides the highest level of safety for customers’ upstream processes as it is qualified for > 4 log10 reduction of small, non-enveloped viruses (e.g., MVM) and as a mycoplasma and leptospira retentive filter.
A major benefit of this new filter is that mid-scale and process filters of the Virosart® Media product family will also be qualified as a sterile filter based on the current ASTM guideline. The first product of the Virosart® Media family is a lab filter with a filtration area of 5.0 cm2 for down-scale, flow and capacity studies. The mid-scale filter with 0.29 m² and the process filters with 1 m² and 3 m² will follow in the second half of 2016.
Providing superior filter capacity for cell culture media and high patient safety is one of the biggest challenges in today’s upstream processing. ”In the past, downstream virus filters have been used in upstream processing as there were no other adequate solutions available. Our new membrane filter Virosart® Media finally closes this gap in the market,” stated Birte Kleindienst, expert for viral clearance at Sartorius Stedim Biotech.
By launching Virosart® Media filter, SSB rounds out customers’ individual risk mitigation strategy in upstream processing with an additional option: With the filters Sartopore® 2 XLG (0.2 μm) for sterile filtration, Sartopore® 2 XLM (0.1 μm) for retention of mycoplasma and with its new Virosart® Media filter (20 nm) for virus retention, SSB enables customers to mitigate risk at three different levels.