Sample prep firm NuGen said this week that it has received current good manufacturing practices certification from the state of California, allowing it to manufacture and ship any of its products under cGMP compliance.
NuGen said that the certification will make it easier for customers to integrate NuGen's sample prep products into diagnostic tests in order to seek regulatory approval for those tests. By using its sample prep products, NuGen added, customers will no longer need to independently establish reproducibility, batch-to-batch consistency, and robustness during the regulatory process.
NuGen, based in San Carlos, Calif., markets a wide variety of sample prep products including next-generation sequencing library preparation systems, RNA/DNA extraction systems, RNA/DNA amplification systems, target prep modules, and sample prep for qPCR and microarrays.
"Our products already provide scientists with new tools to access genetic information from previously unexplorable biological samples, and with our new cGMP certification we're easing the regulatory burden and potentially shortening the approval timeline," Erwin Estigarribia, vice president of operations at the company, said in a statement.
The cGMP certification follows on the heels of NuGen's announcement last week that it signed a distribution agreement with Takara Bio for Japan, South Korea, and China.
Under that agreement, Takara Bio will distribute all of NuGen's next-gen sequencing, microarray, qPCR, and sample prep products. The agreement also authorizes Takara to offer services using NuGen's products in the same territories.
"These offerings complement our current portfolio of … products [and] services in molecular biology and genomics including next-generation sequencing, PCR, real-time PCR, and microarrays," Tsuyoshi Miyamura, general manager of marketing at Takara Bio, said in a statement.