EMD Millipore and Charles River Laboratories have inked an agreement to enhance viral clearance services. Under terms of the deal Charles River gains an exclusive license for EMD Millipore’s TrueSpike™ technology, and the firms will collaborate to integrate TrueSpike into viral clearance services provided by Charles River.
The goal of the deal is to create higher purity virus preparations. This in turn is expected to help ensure validation success and regulatory compliance for biopharmaceutical manufacturers. TrueSpike enables removal of cell debris, DNA, and nonviral 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, according to the companies.
“This exclusive partnership with Charles River brings together their regulatory and viral clearance experience and our extensive knowledge of virus filtration and process engineering,” says Christophe Couturier, vp 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.”
Birgit Girshick, corporate vp of biopharmaceutical services at Charles River, adds, “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. 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.”