QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today the expansion of its digital PCR (dPCR) offering for the development of cell and gene therapies in the biopharma industry.

The company has partnered with Niba Labs to offer customized digital PCR assay design services to biopharma customers and 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 between QIAGEN and Niba Labs, an analytical laboratory with extensive expertise in digital PCR assay development and sample testing, 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). With their combined products and services, QIAGEN and Niba Labs can help cell and gene therapy developers to overcome potential resource constraints and meet demanding project timelines.

“QIAGEN is committed to providing innovative solutions that meet the evolving needs of the biopharma industry,” said Michael Scheffler, Vice President, Head of Life Sciences PCR business at QIAGEN. “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.”

“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,” said David Dobnik, PhD, Chief Scientific Officer at Niba Labs. “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.”

The new CGT Viral Vector Lysis Kit launched for the QIAcuity digital PCR instrument adds to QIAGEN’s rapidly growing digital PCR portfolio for the biopharma industry that includes ten QIAcuity Cell and Gene Therapy (CGT) dPCR Assays for use in adeno-associated virus (AAV) titer quantification and three QIAcuity Residual DNA Quantification Kits for checking carryover of host cell DNA. The new kit provides high repeatability and is capable of determining viral genome titers in single- and multiplex reactions, as well as quantification over a broad dynamic range with high accuracy when combined with the QIAcuity CGT dPCR Assays, making it ideal for drug development and quality control in manufacturing.

“With the introduction of our CGT Viral Vector Lysis Kit, we aim to provide a streamlined protocol for AAV lysis that will bring standardization to bioprocessing workflows and enhance Standard Operating Procedures, quality control and safety. In conjunction with our QIAcuity CGT assays, this kit allows for vector genome titration with remarkable accuracy, repeatability and robustness compared to current workflows,” stated Scheffler.

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.

QIAGEN’s digital PCR platform QIAcuity is based on using nanoplates dispersing a sample over thousands of tiny partitions and then simultaneously reading the reaction in each one, enabling it to quantify even the faintest signals from DNA and RNA. The instruments integrate partitioning, thermocycling, and imaging into one workflow, cutting processing times to only two hours from six. The QIAcuity system is available in one, four, and eight-plate versions – with the four-plate version processing up to 500 samples in an eight-hour shift and the eight-plate version processing more than 850 samples in that time frame.