EMD Millipore Granted Patent For Selective Layering Method That Improves The Consistency Of Virus Filtration Performance

• Method provides EMD Millipore's Viresolve Pro Device with industry-leading performance consistency
• Improves performance consistency by a factor of two 
• Facilitates better process economics, scale-up and regulatory compliance in biopharmaceutical manufacturing

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. 

About EMD Millipore 
EMD Millipore is the U.S. Life Science subsidiary of Merck KGaA, Darmstadt, Germany. As part of the global Life Science business of Merck KGaA, Darmstadt, Germany, EMD Millipore offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the life science tools industry, the Life Science business of Merck KGaA, Darmstadt, Germany, serves as a strategic partner to customers and helps advance the promise of life science. Headquartered in Billerica, Massachusetts, the global business has around 10,000 employees, operations in 66 countries and 2014 revenues of €2.7 billion. For more information, visit www.emdmillipore.com. 

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses - Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials - and generated sales of € 11.3 billion in 2014. Around 39,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company - since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck KGaA, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials. For more information, visit www.emdgroup.com.