EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, has been granted a United States patent for developing a selective layering method that significantly improves the consistency of virus filtration performance. The method is used to manufacture EMD Millipore’s Viresolve® Pro Device, a virus filtration technology that offers highly productive parvovirus clearance for monoclonal antibodies and therapeutic proteins. As a result of selective layering, the Viresolve® Pro Device provides an industry-leading performance consistency superior to other virus filtration devices currently on the market.
The Viresolve® Pro Device uses a dual-layer PES membrane designed to simultaneously deliver high parvovirus log reduction value (LRV), capacity and flux. Using the now patented method, the top and bottom membrane layers are selected from different segments of the normal membrane population and optimally paired to drive performance consistency. This optimal pairing strategy reduces device-to-device throughput performance variability by about half compared to random pairing, while also increasing the average throughput performance. The result is strong batch-to-batch consistency in virus retention, permeability and throughput capacity.
“This new patent reflects EMD Millipore’s ongoing commitment to delivering innovation to our customers in biopharmaceutical manufacturing,” said Udit Batra, President and CEO of EMD Millipore. “Our team of experts developed this methodology to significantly improve upon industry standards for virus clearance unit operations. The resulting performance consistency enables drug manufacturers to accelerate the process of developing drug therapies for patients in need.”
Introduced in 2008, the Viresolve® Pro Device has been proven to enable robust parvovirus clearance and a highly productive virus filtration unit operation. The device offers high mass capacity, as well as optional capacity enhancement with the use of an adsorptive polishing step. In addition, its single-use flowpaths require no cleaning validation and the processing typically takes less than four hours at scale, making the device quick and easy to install and use.