The technology, the latest addition to the Viresolve process filter range, is designed for higher titer feed streams and, according to Millipore, can increase “capacity and productivity” of virus removal during processing operations.
The US firm highlighted both the system’s compatibility with monoclonal antibody and protein production operations as well as its capacity to remove parvoviruses, the smallest viruses found in nature, as its key features.
The Viresolve Pro system also includes a binary gas integrity test to allow the detection of oversized pores in the filter system that can compromise filter retention and allow the end product to become contaminated.
Jean-Paul Mangeolle, president of Millipore’s bioprocess division, suggested that: “Virus safety is an increasingly critical issue in the biopharmacueitcal industry,” citing the impact of “recent incidents of viral contamination” to support the idea.
Mangeolle did not provide any specific examples. However, the well-documented viral contamination problems at Genzyme’s plant in Allston, Massachusetts should serve as a cautionary case-study.
This is because that although Genzyme has now resolved the issues, doing so required that it halt production operations for much of last year, impacting on its earning and placing its dominance of the Gaucher’s disease market at risk.
The Genzyme example, coupled with the drug industry's increasing focus on biologics, may well see demand for filtration technologies and know how increase, which would be good news for Millipore according to VP of downstream processing Paul Chapman.
"As we continue to launch innovative virus products, we're leverageing our product breadth and applications expertise to offer customers complete virsu safety solutions."
Chapman added that Millipore intends to launch a number of validation services and solutions to further expand this part of its business later in the year.