Date: 2013-11-05
Type of information: Collaboration agreement
Compound: Next-Generation Sequencing (NGS) based biosafety assessments
Company: Pathoquest (France) Covance (USA)
Therapeutic area: Technology - Services
Type agreement: collaboration
Action mechanism:
Disease:
Details: * On November 5, 2013, Covance and PathoQuest have announced an exclusive agreement to collaborate in providing Next-Generation Sequencing (NGS) based biosafety assessments. This biosafety testing approach, combined with Covance’s regulatory expertise, provides a flexible testing solution to all biotherapeutic clients and makes biologic medicines safer. Since viral contamination poses a significant potential safety risk to patients, regulatory agencies are increasingly focusing on the use of advanced analytical technologies like NGS for detection of viral contaminants. The new NGS-based platform can detect and identify viral contaminants within biologic compounds (such as monoclonal antibodies or vaccines) throughout the entire lifecycle of the product.
Covance and PathoQuest will provide clients with a wide range of options for adventitious virus identification. This includes a rapid detection protocol for the critical evaluation of major issues within production processes and a more comprehensive approach for development and characterization of cell banks and biological production systems. For small, emerging and virtual biotech companies, representing a growing and valued segment of Covance’s client base, this solution allows them access to a unique technology early in the development process that will increase the value and safety profile of their molecule.
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