TIDMONT
Oxford Nanopore Technologies plc
12 May 2023
Oxford Nanopore and PathoQuest announce next step of strategic
collaboration to bring to market the first sequencing-based quality
control test for biopharma genetic characterisation and safety
Nanopore sequencing combined with PathoQuest expertise offers a
new approach for biologics manufacturing with real-time, accurate
testing for genetic characterisation, cutting months off
traditional methods and providing more complete data.
OXFORD, England and PARIS, France, 12 May 2023: Oxford Nanopore
Technologies plc (LSE: ONT) ("Oxford Nanopore") and PathoQuest SAS
today announce the signing of a definitive agreement to co-develop
a transformational Integration Site Analysis (ISA) test to provide
a Good Manufacturing Practice (GMP) validated nanopore
sequencing-based commercial testing service to the biopharma
industry. This is designed to address the needs of industrial
developers and manufacturers of biological products, for example
monoclonal antibodies or novel proteins that may be used across the
life sciences/healthcare industry.
Oxford Nanopore's technology can read any length of native DNA
with high accuracy, meaning that the technology can identify and
comprehensively sequence gene insertion sites without the risk of
missing off target integrations. In addition, the PathoQuest ISA
test will leverage real-time data streaming, enabling rapid and
accurate clone identification, with the potential to speed up
biopharma manufacturing Quality Control (QC) testing by months over
traditional methods and therefore to support faster or more
effective outcomes for biopharma.
Biologics manufacturing
Most biologics, including monoclonal antibodies (mAbs) and
recombinant proteins, are manufactured using genetically modified
cell lines. For many cell therapies, the product itself is a
genetically modified cell line. Throughout the development of these
products, it is important to characterise and monitor the genetic
modification(s) that have been made and assure the quality and
safety of the product. Classical tests for this application have
limitations in terms of scalability, speed and the completeness of
data provided.
This brand-new test will allow sequencing of both the transgene
and the genomic insertion site, overcoming the limitations of
existing methodologies and delivering an accurate and rapid QC test
for modified cell lines.
Oxford Nanopore and PathoQuest intend the ISA test to be the
first in a line of sequencing-based QC test solutions targeting the
biopharma genetic characterisation and safety market.
Genetic characterisation for monoclonal antibodies
mAbs and their derivatives are transformative drugs that have
enabled the treatment of complex indications in oncology,
immunology and other therapeutic areas. There are now more than 170
mAbs and antibody derivatives designated as drugs with new
approvals increasing yearly.
To develop a manufacturing cell line for mAbs, antibody encoding
genes (transgenes) need to be stably integrated into mammalian
cells, generally Chinese Hamster Ovary (CHO) cells, to develop both
Master and Working Cell Banks for future commercial manufacturing
batches. However, the identification of a CHO cell line which
produces high amounts of the mAb is extremely challenging and
resource intensive using current gold standard methods.
To make situations more complex, the transgene encoding for the
antibody may not always integrate correctly and can be truncated,
rearranged, duplicated and/or integrate in unwanted locations. With
classical methods, identifying an optimal cell line clone requires
screening using a multitude of different tests to detect stable and
correct integration sites before the mAb's desired mode of action
can be explored and a high producing cell can be identified.
Current gold standard methods for the characterisation of the
mAb cell banks are slow and error prone, with random off target
integrations potentially missed. Long nanopore reads allow for
sequencing the vector and the transgene - as opposed to only
focusing on the transgene with short-reads - giving a broader
picture on what has been developed and a stronger guarantee of
accuracy, expediting the development process.
The PathoQuest validated ISA test will allow for rapid initial
clone selection and subsequently will provide assurance that the
desired high production mAb cell bank is maintained throughout the
entire development and manufacturing life cycle, thus significantly
reducing production risks.
Genetic characterisation for cell therapy
Cell therapy is a rapidly growing field. Pharmaceutical
companies have invested significantly in this area and an
increasing number of products are now licensed in regenerative
medicine, immune diseases, and cancer.
ISA is also important in cell therapy, where genetically
modified cells are often the product itself. A comprehensive and
thorough understanding of the integration locations and frequency
is important to ensure the safety and quality of these
products.
Gordon Sanghera, CEO, Oxford Nanopore Technologies,
commented:
"We are pleased to announce the next step of our partnership
with PathoQuest, and we are excited to start on the development of
this breakthrough test for biologics manufacturing. Nanopore
sequencing offers a transformational new approach for robust and
accurate genetic characterisation of biological materials, which we
believe will enable the release of novel therapeutics with more
certainty and safety assurance than ever before."
Jean-François Brepson, CEO, PathoQuest commented:
"We are excited to be selected as the partner of choice in
biologics Quality Control services by Oxford Nanopore Technologies.
We will use our know how and expertise to optimise and validate
this Integration Site Analysis test, bringing it to market as a GMP
service from our facilities in Paris France and Wayne PA. It will
enable our customers to understand their cell lines more
comprehensively and more quickly so they can proceed with more
certainty."
-ENDS-
About Oxford Nanopore Technologies
Oxford Nanopore Technologies' goal is to bring the widest
benefits to society through enabling the analysis of anything, by
anyone, anywhere. The company has developed a new generation of
nanopore-based sensing technology for real-time, high-performance,
accessible and scalable analysis of DNA and RNA. The technology is
used in more than 120 countries to understand the biology of humans
and diseases such as cancer, plants, animals, bacteria, viruses and
whole environments. Oxford Nanopore Technologies products are
intended for molecular biology applications and are not intended
for diagnostic purposes. www.nanoporetech.com
Forward-looking statements This announcement contains certain
forward-looking statements. Phrases such as "potential", "expect",
"intend", "believe we can", "working to", "anticipate", "when
validated", and similar expressions of a future or forward-looking
nature should also be considered forward-looking statements.
Forward-looking statements address our expected future business,
and by definition address matters that are, to different degrees,
uncertain and may involve factors beyond our control.
About PathoQuest
With over 20 peer reviewed publications on NGS applications in
biosafety testing, PathoQuest is a leading expert in the
application of Good Manufacturing Practices (GMP)-compliant next
generation sequencing (NGS)-based biosafety testing. PathoQuest
offers biopharmaceutical companies a game-changing genomic approach
to ensuring the safety of biologics such as cell and gene therapy
products, vaccines, and recombinant drugs, ultimately enabling a
reduction in the time to market for these innovative treatments.
PathoQuest's technology combines NGS platforms with proprietary
sample preparation and data analysis processes to bring novel
solutions to the industry. PathoQuest, headquartered in Paris,
France, with a US based site in Wayne (PA) has worked with over 100
of the leading biopharmaceutical companies globally.
www.pathoquest.com/
CONTACTS
Oxford Nanopore
Media Relations Teneo (communication adviser to the
Company)
media@nanoporetech.com Tom Murray, Olivia Peters
Tel.: +44 (0) 20 7353 4200
Investor Relations
ir@nanoporetech.com OxfordNanoporeTechnologies@teneo.com
PathoQuest
contact@pathoquest.com
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