Qiagen expands range of digital PCR kits and services for biopharma industry

The company has partnered with Niba Labs to offer customized digital PCR assay design services to biopharma customers. It has also launched the new CGT Viral Vector Lysis Kit that enables a standardized workflow from cell lysates to absolute and precise quantification of viral titers for multiple serotypes.

The partnership will allow QIAcuity customers to use the ‘combined expertise’ of both companies to develop new custom simplex or multiplex assays for the quantification of nucleic acids and to optimize existing qPCR assays for the use in digital PCR.

Niba Labs will evaluate the performance of the assays and validate them within Good Manufacturing Practice (GMP).

By merging their products and services, Qiagen and Niba Labs can help cell and gene therapy developers to ‘overcome potential resource constraints’ and meet project timelines.

Michael Scheffler, vice president, head of life sciences PCR business at Qiagen, said: “Qiagen is committed to providing innovative solutions that meet the evolving needs of the biopharma industry.”

“We have recently expanded our digital PCR portfolio, adding new assays and kits for cell and gene therapy applications for the QIAcuity. Our partnership with Niba Labs will help us to further strengthen our biopharma offering and provide customers with customized solutions that address their unique challenges.”

David Dobnik, chief scientific officer at Niba Labs, added: “Niba Labs is committed to developing innovative analytical solutions for the biopharma industry focused on cell and gene therapies, thoroughly investigating quality attributes such as vector genome titer and genome integrity.”

“We have addressed the issue of AAV vector genome integrity by developing an advanced dPCR multiplex approach. We trust that our partnership with QIAGEN will provide the biopharma industry with most advanced analytical solutions to meet the evolving industry requirements and further advance their cell and gene therapy products.”

Biopharmaceutical customers developing next-generation therapies are increasingly adopting dPCR to enhance drug safety and efficacy.

Compared to qPCR, dPCR technology provides a much higher level of sensitivity and accuracy that can be leveraged for multiple applications in the drug development process – from drug discovery and clinical trials to manufacturing.