Billerica, MA — EMD 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 EMD Millipore’s TrueSpike™ technology. EMD 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, EMD 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 EMD Millipore to offer this service to our clients through our global network of sites in Cologne, Germany and Pennsylvania, USA.”