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Merck Millipore Partners with Charles River Laboratories for Improved Viral Clearance Studies
- Patent-pending TrueSpike™ technology produces virus preparations of exceptional quality for filter validation studies
- Higher purity virus preparations combined with expertise from each company ensures validation success and regulatory compliance
February 27, 2012, Darmstadt, Germany — Merck Millipore, the Life Science division of Merck KGaA* of Germany, today announced it will be partnering with Charles River Laboratories International, Inc. of Wilmington, MA, to exclusively license Merck Millipore’s TrueSpike™ technology. Merck Millipore and Charles River will collaborate to integrate the TrueSpike™ technology into viral clearance services provided by Charles River, which is designed to result in a more predictable and consistent study outcome for clients, and ultimately helping to improve drug product safety. The combined expertise of these two industry leaders will result in higher purity virus preparations to help ensure validation success and regulatory compliance for biopharmaceutical manufacturers.
“This exclusive partnership with Charles River brings together their regulatory and viral clearance experience and our extensive knowledge of virus filtration and process engineering,” describes Christophe Couturier, Vice President of Services and Solutions, Merck Millipore. “The increased quality of virus preparations as delivered by TrueSpike™ technology will help ensure the success of our customers’ validation studies conducted by Charles River.”
TrueSpike™ technology enables removal of cell debris, DNA, and non-viral proteins from virus preparations used to validate biomanufacturing process virus clearance. Use of TrueSpike™ technology reduces the protein content of virus preparations used for validation studies up to 600 fold, as demonstrated with our TrueSpike MVM (minute mouse virus). A significantly cleaner prep can lead to increased predictability of validation studies, enabling assured achievement of validation targets.
“Our goal at Charles River is to provide clients with a complete range of required services that meet their regulatory and scientific needs. This partnership enhances our ability to exceed client expectations by offering a cost effective, innovative solution that accelerates the production and safety assessment of their biopharmaceutical product,” said Birgit Girshick, Corporate Vice President of Biopharmaceutical Services at Charles River. “We look forward to working with Merck Millipore to offer this service to our clients through our global network of sites in Cologne, Germany and Pennsylvania, USA.”
For more information about TrueSpike™ technology, please visit: www.millipore.com/media/flx2/webinars#virusfilter2.
For more information about viral clearance services, please visit: www.criver.com/bps.
About Merck Millipore
Merck Millipore is the Life Science division of Merck KGaA of Germany and 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, Merck Millipore serves as a strategic partner to customers and helps advance the promise of life science. Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2010 revenues of EUR 1.7 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada.
Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany
About Charles River
Accelerating Drug Development. Exactly. Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Charles River’s dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about Charles River’s unique portfolio and breadth of services, visit www.criver.com.