Cygnus Technologies (Cygnus), TriLink BioTechnologies, both part of Maravai LifeSciences have collaborated to launch Cygnus’ AccuRes™ Host Cell DNA Quantification Kits. Together, the companies have leveraged state-of-the-art technologies and reagents to develop an assay with unparalleled sensitivity and specificity to help produce safer, more stable biotherapeutics that surpass regulatory standards.
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.
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“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.”
SOURCE: Businesswire