Enhances viral safety while maintaining cell line productivity, protein quality
Merck has launched a first-of-its-kind gene editing technology to modify CHO cell lines to be resistant to minute virus of mice (MVM), a common contamination threat that remains despite the shift to chemically defined, animal component-free manufacturing processes.
CHO cells are commonly used in the manufacture of biologics. Merck’s new Centinel technology targets genes which play a role in MVM susceptibility. Viral contaminations like MVM can have major consequences for biopharmaceutical manufacturers, costing hundreds of millions of dollars, according to industry reports. The greatest impact of such contamination is on patients, as access to therapies can be put in jeopardy. Centinel technology provides manufacturers with an additional path for mitigating the risk of MVM contamination, while maintaining an equivalent level of protein quality and cell line productivity.
“The Centinel programme is just one example of how we are combining years of expertise and credibility in process development, biologics manufacturing and gene editing tools to increase safety for our customers and their patients,” said Udit Batra, member of the Merck Executive Board and CEO, Life Science.
“We are also leveraging this unique combination of experience and technologies to address some of the industry’s most complex challenges and exciting applications, including cell therapy.”
Under the Centinel programme, Merck can modify customers’ CHO cell lines to provide viral resistance to MVM. A patent application has been submitted for the technology used in the gene editing approach to viral resistance. The company’s BioReliance testing services can validate MVM resistance and demonstrate the virus is not propagated in the cell line.
Alternatively, customers can purchase the zinc finger nuclease pairs to engineer cell lines directly. Merck’s new Centinel technology builds on the company’s expertise in gene editing and biomanufacturing processes, as well as its in-depth understanding of the regulatory environment. In addition to enhancing the safety of biomanufacturing, Merck is also applying this expertise and approach to develop other technologies and services, including those supporting the cell therapy industry.
EP News Bureau