AccuRes Host Cell DNA kits use probe-based quantification to ensure specificity for the target host cell line as opposed to off-target DNA. The FAM-labeled nucleic acid probe is quenched by BHQ-1™ until PCR extension. The kits are compatible with any qPCR instrument that detects FAM signal, eliminating the added cost of purchasing additional equipment or reagents. The all-in-one kit includes all reagents for DNA extraction in a plate or microfuge tube format, AccuRes PCR master mix, primer/probe mix, and DNA standard – all with demonstrated sensitivity (a limit of detection of 0.6 fg/µL).
The all-in-one kit combines Cygnus’ proprietary extraction procedure with a probe-based master mix containing TriLink’s patented CleanAmp® dNTPs and a Hot Start Taq DNA Polymerase.
“This collaboration between Cygnus and TriLink has allowed us to bring decades of experience and advanced technology to the development of AccuRes,” said Alla Zilberman, VP of Technical Marketing and Business Development at Cygnus. “With these novel host cell DNA quantification kits, our customers will be able to utilize Cygnus for all their host cell protein and host cell DNA analysis needs.”
Residual host cell DNA may remain during biotherapeutic manufacturing and needs to be monitored and removed to ensure drug safety and stability. Regulatory standards mandate host cell DNA levels do not exceed 10-100 pg/dose, requiring a sensitive and accurate assay to monitor in-process samples and final drug substances for lot release. AccuRes kits are sensitive and specific for the host cell species, and compatible with various real-time PCR instruments, offering flexibility and cost savings without compromising sensitivity.
“As the industry continues to innovate and develop more complex biotherapeutics, it’s critical we have the capabilities to ensure these drug substances are safe and stable,” shared Justin Barbosa, VP and General Manager of TriLink Discovery. “Our CleanAmp dNTPs improve sensitivity, specificity, and prevent mis-priming -- it’s a great addition to any assay. We’re grateful for the collaboration with Cygnus and look forward to future opportunities.”
About Cygnus Technologies, LLC:
Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics as well as in innovative viral clearance solutions. Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics prior to human trials, regulatory approval and commercial release.
About TriLink BioTechnologies:
TriLink BioTechnologies, a Maravai LifeSciences company, is a global leader in nucleic acid and mRNA solutions. TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its patented CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech disruptors, and world governments depend on TriLink to meet their greatest challenges, from delivering the COVID-19 vaccine at warp speed, to empowering innovative treatments in oncology, infectious diseases, cardiology, and neurological disorders, to enabling future pandemic response plans.
About Maravai LifeSciences:
Maravai is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, and novel vaccines. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world’s leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapy companies.
