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Charles River rolls toward improved viral clearance studies
BILLERICA, Mass.—In an effort to improve the viral clearance studies it provides its clients, Charles River has reached a licensing contract with EMD Millipore, the life-science division of Merck, for the company's TrueSpike technology.
EMD Millipore and Charles River will 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, 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," says Christophe Couturier, vice president of services and solutions at 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."
According to Birgit Girshick, Charles River's biopharmaceutical services corporate vice president, while the companies have worked together on several projects over the years, this marks the first formal project between the two. Moreover, Girshick says the 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 an innovative solution that accelerates the production and safety assessment of their biopharmaceutical product," she says.
Christophe Eyer, head of global services at EMD Millipore, explains that TrueSpike enables the removal of cell debris, DNA and non-viral proteins from virus preparations used to validate biomanufacturing process virus clearance.
"This partnership is about combining the expertise of both companies in order to provide a better viral clearance experience to biopharma customers," he says. "It will allow them to make better decisions about their future manufacturing process, resulting in reduced timelines and costs."
Eyer adds that the use of TrueSpike technology reduces the impurity content of virus preparations. He explains that a significantly cleaner prep can lead to increased predictability of validation studies, enabling assured achievement of validation targets.
"TrueSpike is a process that allows us to highly purify viruses from cell lines," he notes. "It allows more consistent and representative virus representation that is used in bioclearance studies and spiking studies."
The collaboration will lead to an enhanced service by Charles River.
"In addition to Merck Millipore's TrueSpike technology that we are implementing at Charles River, customers will have access to Millipore's engineers as well as our viral clearance experts during the study at the site," says Girshick. "That assures the customers that there is not only regulatory compliance, but also an integrated process engineering component during the study that wasn't there before."
The long-term implications for the viral clearance services could have a far-reaching impact, she notes.
"We see it as a possible use for all virus filtration steps worldwide," Girshick says. "I think that once the customers see the benefits of it, they will want to use a highly purified virus stock."
While it certainly is a growing market with a high ceiling, Girshick says putting a figure on the potential revenue is nearly impossible.
"Basically, every company that, from a regulatory perspective, has to do viral clearance studies will have an interest in using a virus stock with minimal impurities and lot-to-lot variability," she explains.
After implementation, Girshick says, "it will become our gold standard for the virus filtration portion of the viral clearance study."
It also will eliminate many challenges inherent in the process, according to Eyer.
"Virus spiking can present some challenges because of the virus stock that often contain impurities, which can dramatically affect performance of virus removal filters by reducing their throughputs and results," he says. "As a consequence, insufficiently purified and characterized virus preps can cause validation failure for the end result."