EMD Millipore, the life science division of Merck based in Billerica, Mass., will partner with Charles River Laboratories to exclusively license the TrueSpike technology, which reduces protein content of virus preparations and increases predictability of validation studies.
EMD and Charles River will collaborate to integrate the TrueSpike technology into viral clearance services provided by Charles River, designed to result in a more predictable and consistent study outcome for clients, ultimately helping to improve drug product safety. The companies’ combined expertise 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,” said Christophe Couturier, vice president of services and solutions, EMD. “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, which can lead to increased predictability of validation studies.