1. In cell and gene therapy, 13 novel kits and assays make it possible to measure the amount of remaining host cell DNA and the AAV virus titer.
2. Users of dPCR have access to customised multiplex assays for use outside of biopharma applications thanks to custom assay design.
3. Milestone reached with more than 1,000 total installations of the industry-leading QIAcuity systems
Today, QIAGEN unveiled a number of improvements for its QIAcuity line of digital PCR (dPCR) instruments that are intended to increase usage among clients, particularly those working in the biopharma sector:
Ten new QIAcuity Cell and Gene Therapy (CGT) dPCR Assays are now available for use in adeno-associated virus (AAV) titer measurement, and three new QIAcuity Residual DNA Quantification Kits are available to examine host cell DNA carryover.
In order to support GMP compliance, a new version of the QIAcuity Software Suite has been released with increased functionality.
The significant increase in QIAGEN’s dPCR assay options follows the achievement of a milestone with more than 1,000 total QIAcuity system installations since its launch in late 2020. Nanoplates are used by QIAcuity’s digital PCR method to partition the samples more quickly than other methods. The tools, which come in versions for one, four, and eight plates, combine partitioning, thermocycling, and imaging into a single workflow, reducing processing times from six hours to just two.
“We tested QIAGEN’s QIAcuity dPCR for quantification of viral titer, vector copy number and residual host cell DNA – all critical to in-process quality control in gene therapy. It is easy to use, fast, scalable and complies with requirements for GMP”, “The system is a great addition to our analytical development and testing services, process development and R&D platforms which is available to our clients now.”
Dana Cipriano, Senior Vice President, Testing and Analytical Services, Center for Breakthrough Medicines in King of Prussia, PA, in the U.S.
“The new cell and gene therapy applications will increase the utility of QIAcuity for biopharma customers, meeting their need for high-throughput analytical methods, rapid turnaround times, wet-lab verified catalog assays, multiplexing and more”, “Our custom assays for dPCR build on decades of expertise in assay design for traditional qPCR. The Expert Custom Assay Design Service will extend customer choice beyond the existing catalog of assays, especially in key application areas that require simultaneous detection of up to five molecular markers.”
Thomas Schweins, Senior Vice President and Head of QIAGEN’s Life Sciences Business Area
Ten QIAcuity Cell and Gene Therapy (CGT) Assays that can be designed with multiple fluorophores and quickly generate results of exceptional accuracy and reproducibility with a dynamic range of at least four orders of magnitude will be made available to biopharma customers. These assays have undergone wet-lab verification.
The QIAcuity Residual DNA Quantification Kits are aimed at the biopharmaceuticals industry and can detect residual host cell DNA (resDNA) of CHO, E. coli, and HEK293 cells used in CGT even in the presence of PCR contaminants and other inhibitory reagents in samples. Together, these three new kits plus the new QIAcuity UCP Probe PCR Kit, which features an ultra-clean master mix and enables residual DNA detection among other quality control applications, reduce contaminated DNA background.
When paired with the updated QIAcuity Software Suite, biopharma customers can benefit from a turnkey workflow for the development and manufacturing of cell and gene therapies. Version 2.1 of the software, among other things, includes client-defined user management with customized permissions, improved plate ownership, an electronic signature for reports (to meet the FDA 21 CFR Part 11 requirement), an audit trail status indicator and robust cybersecurity.
Complementing the menu expansion is the introduction of the Expert Custom Assay Design Service, to be made available globally from the end of July, allowing dPCR users to source custom multiplex assays – for detecting various pathogens, rare mutations, copy number variations and other molecular phenomena. From design freeze to assay shipment reduced to only two weeks, customers will save time and cost. Customers will be able to access, manage and order their assays through QIAGEN’s GeneGlobe Design & Analysis Hub. On top of that, they will have access to the QIAGEN Genomic Services Team for wet-lab assay verification.
To improve drug safety and efficacy, biopharmaceutical clients who are creating next-generation medicines are increasingly embracing dPCR. The dPCR technology, which offers a significantly greater level of sensitivity and accuracy than qPCR, can be used for a variety of applications in the drug development process, including drug discovery, clinical trials, and manufacturing. According to recent market research estimates, the dPCR market in the biopharma industry is now expanding at a healthy double-digit rate and will reach multi-billion dollar levels in the upcoming years.