QIAGEN expands range of digital PCR kits and services for the biopharma industry
18 Julho 2023 - 5:05PM
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.
More information on cell and gene therapy with digital PCR can
be found here:
https://www.qiagen.com/applications/pharma-biotech/applications/cell-and-gene-therapy
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. Our 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) and Life Sciences (academia, pharma
R&D and industrial applications, primarily forensics). As of
March 31, 2023, QIAGEN employed more than 6,200 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, including those
products used in the response to the COVID-19 pandemic, timing for
launch and development, marketing and/or regulatory approvals,
financial and operational outlook, growth and expansion,
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; actions of governments, global or
regional economic developments, weather or transportation delays,
natural disasters, political or public health crises, including the
breadth and duration of the COVID-19 pandemic and its impact on the
demand for our products and other aspects of our business, or other
force majeure events; as well as the possibility that expected
benefits related to recent or pending acquisitions may not
materialize as expected; and the other factors discussed under the
heading “Risk Factors” contained in Item 3 of our most recent
Annual Report on Form 20-F. 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.
Source: QIAGEN N.V.
Category: Corporate
John Gilardi
QIAGEN N.V.
+49 2103 29 11711
ir@qiagen.com
Phoebe Loh
QIAGEN N.V.
+49 2103 29 11457
Thomas Theuringer
QIAGEN N.V.
+49 2103 29 11826
Daniela Eltrop
QIAGEN N.V.
+49 2103 29 11676
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