Covance partnership aims to expand next-gen sequencing offering

07-Nov-2013 - Last updated on 07-Nov-2013 at 13:36 GMT

The partnership seeks to stamp out vaccine and biologics contaminations

Covance and Pathoquest have announced an exclusive agreement to collaborate in providing next-generation sequencing (NGS)-based biosafety assessments.

The NGS-based platform can help detect and identify viral contaminants within biologic compounds, such as monoclonal antibodies or vaccines. Regulatory agencies are increasingly focusing on the use of advanced analytical technologies like NGS for detection of viral contaminants.

“The NGS platform and collaboration with Pathoquest ensure that we are well placed to help biologics manufacturers and clients transition to the anticipated switch over to the NGS platform for this purpose,” Raymond Kaiser, PhD, Covance global VP of BioPharmaceutical Chemistry, Manufacturing and Control (CMC) Solutions told Outsourcing-Pharma.com.

With more than 20 years of experience in biosafety testing, Covance is well versed in using industry standard and well-documented in-vitro and in-vivo techniques, he added.

“This service is applicable to anyone interested in identifying viruses in a variety of matrices, not just the biologics market although it is anticipated that this will be by far the largest market for this application,” Dr. Kaiser noted.

NGS systems have detected viral contaminations in a number of commercially released biologics and the industry is increasingly adopting the technology, the companies claim.

The Covance/Pathoquest NGS solution aims to overcome the primary limitation of traditional approaches that only identify a predefined, short list of viruses. Their new tool will seek to provide a universal test for identifying any virus in a single, comprehensive analysis that minimizes false negatives.

The companies will also be able to provide their clients with a range of options for adventitious virus identification, including a rapid detection protocol for the evaluation of major issues within production processes and for the development and characterization of cell banks and biological production systems.

“This collaboration ensures that Covance can offer a robust and advanced platform for anticipated changes in the way that viral safety is determined -- a switch to the NGS platform. There is a growing client drive to look at this technique for this purpose, but the main driver is anticipated market and regulatory changes,” Dr. Kaiser told us.