- 13 new kits and assays allow for quantification of AAV viral
titer and residual host cell DNA in cell and gene therapy
- Custom assay design provides dPCR users with access to
tailored multiplex assays for use beyond biopharma
applications
- Milestone achieved with over 1,000 cumulative placements of
the standard-setting QIAcuity systems
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced
today a series of enhancements for its QIAcuity series of digital
PCR (dPCR) instruments designed to drive greater use among
customers, particularly those involved in the biopharma
industry:
- New solutions are now available with ten new QIAcuity Cell and
Gene Therapy (CGT) dPCR Assays for use in adeno-associated virus
(AAV) titer quantification and three new QIAcuity Residual DNA
Quantification Kits for checking carryover of host cell DNA.
- A new version of the QIAcuity Software Suite has been released
with expanded functionality to support good manufacturing practice
(GMP) compliance.
The major expansion of QIAGEN’s dPCR assay offerings comes after
a milestone was achieved with more than 1,000 cumulative placements
of the QIAcuity system since launch in late 2020. QIAcuity’s
approach to digital PCR is based on using nanoplates to partition
the samples more quickly than other systems. The instruments –
available in one, four and eight-plate versions – integrate
partitioning, thermocycling and imaging into one workflow, cutting
processing times to only two hours from six.
“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,” said Dana
Cipriano, Senior Vice President, Testing and Analytical Services,
Center for Breakthrough Medicines in King of Prussia, PA, in the
U.S. “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.”
“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,” said Thomas
Schweins, Senior Vice President and Head of QIAGEN’s Life Sciences
Business Area. “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.”
Biopharma customers will benefit from the launch of ten wet-lab
verified QIAcuity Cell and Gene Therapy (CGT) Assays which can be
designed with multiple fluorophores, and quickly produce results of
superior accuracy and reproducibility, with a dynamic range of at
least four orders of magnitude.
The biopharmaceuticals sector is also the target group for the
QIAcuity Residual DNA Quantification Kits for detecting residual
host cell DNA (resDNA) of CHO, E. coli and HEK293 cells used in
CGT, even when PCR contaminants and other inhibitory reagents are
present in samples. These three new kits work in conjunction with
the new QIAcuity UCP Probe PCR Kit that has an ultra-clean master
mix to minimize contaminating DNA background and enable residual
DNA testing among other quality control applications.
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.
Biopharmaceutical customers developing next-generation therapies
are increasingly adopting dPCR to enhance drug safety and efficacy.
Compared to qPCR, the 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. The market for dPCR in
biopharma is currently growing at a solid double-digit pace and
becoming a multi-billion dollar market in the coming years,
according to recent market research reports.
For more information, please visit
https://www.qiagen.com/applications/pharma-biotech.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading
global provider of Sample to Insight solutions that enable
customers to gain valuable molecular insights from samples
containing the building blocks of life. Ouar sample technologies
isolate and process DNA, RNA and proteins from blood, tissue and
other materials. Assay technologies make these biomolecules visible
and ready for analysis. Bioinformatics software and knowledge bases
interpret data to report relevant, actionable insights. Automation
solutions tie these together in seamless and cost-effective
workflows. QIAGEN provides solutions to more than 500,000 customers
around the world in Molecular Diagnostics (human healthcare),
Applied Testing (primarily forensics), Pharma (pharma and biotech
companies) and Academia (life sciences research). As of March 31,
2021, QIAGEN employed more than 6,000 people in over 35 locations
worldwide. Further information can be found at
http://www.qiagen.com.
Forward-Looking Statement
Certain statements contained in this press release may be
considered forward-looking statements within the meaning of Section
27A of the U.S. Securities Act of 1933, as amended, and Section 21E
of the U.S. Securities Exchange Act of 1934, as amended. To the
extent that any of the statements contained herein relating to
QIAGEN's products, collaborations markets, strategy or operating
results, including without limitation its expected adjusted net
sales and adjusted diluted earnings results, are forward-looking,
such statements are based on current expectations and assumptions
that involve a number of uncertainties and risks. Such
uncertainties and risks include, but are not limited to, risks
associated with management of growth and international operations
(including the effects of currency fluctuations, regulatory
processes and dependence on logistics), variability of operating
results and allocations between customer classes, the commercial
development of markets for our products to customers in academia,
pharma, applied testing and molecular diagnostics; changing
relationships with customers, suppliers and strategic partners;
competition; rapid or unexpected changes in technologies;
fluctuations in demand for QIAGEN's products (including
fluctuations due to general economic conditions, the level and
timing of customers' funding, budgets and other factors); our
ability to obtain regulatory approval of our products; difficulties
in successfully adapting QIAGEN's products to integrated solutions
and producing such products; the ability of QIAGEN to identify and
develop new products and to differentiate and protect our products
from competitors' products; market acceptance of QIAGEN's new
products and the integration of acquired technologies and
businesses. For further information, please refer to the
discussions in reports that QIAGEN has filed with, or furnished to,
the U.S. Securities and Exchange Commission (SEC).
Source: QIAGEN N.V. Category: Corporate
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version on businesswire.com: https://www.businesswire.com/news/home/20220726006212/en/
QIAGEN: Investor Relations John Gilardi +49 2103
29 11711 Phoebe Loh +49 2103 29 11457 e-mail: ir@QIAGEN.com
Public Relations Thomas Theuringer +49 2103 29 11826
e-mail: pr@QIAGEN.com
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