BILLERICA, Mass.—In an effort to improve the viral clearancestudies it provides its clients, Charles River has reached a licensing contractwith EMD Millipore, the life-science division of Merck, for the company'sTrueSpike technology.
EMD Millipore and Charles River will integrate the TrueSpiketechnology into viral clearance services provided by Charles River, which isdesigned to result in a more predictable and consistent study outcome forclients, ultimately helping to improve drug product safety. The combinedexpertise of these two industry leaders will result in higher-purity viruspreparations to help ensure validation success and regulatory compliance forbiopharmaceutical manufacturers.
"This exclusive partnership with Charles River bringstogether their regulatory and viral clearance experience and our extensiveknowledge of virus filtration and process engineering," says ChristopheCouturier, vice president of services and solutions at EMD Millipore. "Theincreased quality of virus preparations as delivered by TrueSpike technologywill help ensure the success of our customers' validation studies conducted byCharles River."
According to Birgit Girshick, Charles River'sbiopharmaceutical services corporate vice president, while the companies haveworked together on several projects over the years, this marks the first formalproject between the two. Moreover, Girshick says the goal at Charles River isto provide clients with a complete range of required services that meet theirregulatory and scientific needs.
"This partnership enhances our ability to exceed clientexpectations by offering an innovative solution that accelerates the productionand 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-viralproteins from virus preparations used to validate biomanufacturing processvirus clearance.
"This partnership is about combining the expertise of bothcompanies in order to provide a better viral clearance experience to biopharmacustomers," he says. "It will allow them to make better decisions about theirfuture manufacturing process, resulting in reduced timelines and costs."
Eyer adds that the use of TrueSpike technology reduces theimpurity content of virus preparations. He explains that a significantlycleaner prep can lead to increased predictability of validation studies,enabling assured achievement of validation targets.
"TrueSpike is a process that allows us to highly purifyviruses from cell lines," he notes. "It allows more consistent andrepresentative virus representation that is used in bioclearance studies andspiking studies."
The collaboration will lead to an enhanced service byCharles River.
"In addition to Merck Millipore's TrueSpike technology thatwe are implementing at Charles River, customers will have access to Millipore'sengineers as well as our viral clearance experts during the study at the site,"says Girshick. "That assures the customers that there is not only regulatorycompliance, but also an integrated process engineering component during thestudy that wasn't there before."
The long-term implications for the viral clearance servicescould have a far-reaching impact, she notes.
"We see it as a possible use for all virus filtration stepsworldwide," Girshick says. "I think that once the customers see the benefits ofit, 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 nearlyimpossible.
"Basically, every company that, from a regulatoryperspective, has to do viral clearance studies will have an interest in using avirus stock with minimal impurities and lot-to-lot variability," she explains.
After implementation, Girshick says, "it will become ourgold standard for the virus filtration portion of the viral clearance study."
It also will eliminate many challenges inherent in theprocess, according to Eyer.
"Virus spiking can present some challenges because of thevirus stock that often contain impurities, which can dramatically affectperformance of virus removal filters by reducing their throughputs andresults," he says. "As a consequence, insufficiently purified and characterizedvirus preps can cause validation failure for the end result."