Dyadic International Inc. (“Dyadic”, or the “Company”) (Nasdaq:
DYAI) and Cygnus Technologies®, part of Maravai LifeSciences®
(Nasdaq: MRVI), announced today a strategic partnership for the
quantification of Host Cell Proteins (“HCP”) from the proprietary
and patented C1-cells filamentous fungus Thermothelomyces
heterothallica, (formerly Myceliophthora thermophila). Under the
terms of the partnership agreement, Cygnus has developed the C1 HCP
ELISA Kit, which will be made available to Dyadic and Cygnus
customers.
HCP measurements are critical quality-control
steps in biopharmaceutical development because the presence of
these impurities in the final product can potentially interfere
with drug efficacy, induce an undesired immune response, or impact
drug stability. Biopharmaceutical manufacturers monitor HCPs to
demonstrate reproducibility of their purification process, ensure
HCP clearance and perform product lot release testing. The
development of the C1 HCP ELISA Kit further demonstrates that
Dyadic’s C1 protein expression platform is keeping pace with
industry standards for HCP analysis in biopharmaceutical
manufacturing.
Cygnus Technologies is an industry pioneer
responsible for developing and commercializing the first generic
assay kits for HCP detection. Cygnus Technologies’ HCP ELISA Kits
have long been considered the gold standard in HCP impurity
quantification, and its reputation for quality is recognized by
industry and global regulatory agencies. The antibody used in the
kit has been evaluated for reactivity to more than 1,000 individual
HCPs present in C1 strains by state-of-the-art antibody affinity
extraction and mass spectrometry methods. The kit has been
qualified with many drug substances and in-process samples,
providing the specificity and sensitivity to detect C1-HCP
impurities with reproducibility that supports downstream
purification monitoring, product lot release and regulatory
compliance.
Mark Emalfarb, CEO of Dyadic, commented, “I
can’t stress enough the significance of our partnership with
Cygnus, the C1 HCP assay provides adopters of our C1 microbial
production platform a solution for testing C1 HCP impurity during
product lot release testing, thereby enhancing the quality
assurance process in biomanufacturing. The biopharmaceutical
industry demands a fast, efficient, and reliable method for
monitoring HCPs during manufacturing to ensure the delivery of safe
and efficacious products in a cost-effective manner. Our
collaboration with Cygnus resulted in the development of a
first-in-class C1 HCP ELISA assay, making a significant step toward
greater adoption of the C1 technology globally.”
Christine Dolan, Cygnus Technologies Chief
Operating Officer, stated, “We are very excited about the launch of
the highly anticipated C1 HCP ELISA Assay. The assay is expected to
play an important role in facilitating the broad adoption of
Dyadic's C1 protein production platform which enables rapid and
efficient low-cost production of antigens, monoclonal antibodies,
and other therapeutic proteins. We are proud to partner with Dyadic
to help accelerate the adoption of their C1 platform, ultimately
aiming to enhance access and affordability of healthcare for
patients in developed and developing countries.”
About Cygnus Technologies,
LLC
Cygnus Technologies, part of Maravai
LifeSciences, is the biopharmaceutical industry’s partner in host
cell protein (HCP) and other process-related impurity detection and
analytics as well as in innovative viral clearance solutions.
Cygnus helps companies developing therapeutic proteins, vaccines,
antibodies, plasma derivatives and gene therapies to ensure the
safety of biotherapeutics prior to human trials, regulatory
approval and commercial release. For more information on Cygnus
Technologies, please visit www.cygnustechnologies.com.
About Maravai
Maravai is a leading life sciences company
providing critical products to enable the development of drug
therapies, diagnostics and novel vaccines. Maravai’s companies are
leaders in providing products and services in the fields of nucleic
acid synthesis and biologics safety testing to many of the world's
leading biopharmaceutical, vaccine, diagnostics, and cell and gene
therapy companies. For more information about Maravai LifeSciences,
visit www.maravai.com.
Media Contact:Deb Hart Maravai LifeSciences+ 1
858-988-5917ir@maravai.com
About Dyadic International,
Inc.
Dyadic International, Inc. is a global
biotechnology company focused on building innovative microbial
platforms to address the growing demand for global protein
bioproduction and unmet clinical needs for effective, affordable,
and accessible biopharmaceutical products and alternative proteins
for human and animal health.
Dyadic’s gene expression and protein production
platforms are based on the highly productive and scalable
fungus Thermothelomyces heterothallica (formerly
Myceliophthora thermophila). Our lead technology, C1-cell
protein production platform, is based on an industrially proven
microorganism (named C1), which is currently used to speed
development, lower production costs, and improve performance of
biologic vaccines and drugs at flexible commercial scales for the
human and animal health markets. Dyadic has also developed the
Dapibus™ filamentous fungal based microbial protein production
platform to enable the rapid development and large-scale
manufacture of low-cost proteins, metabolites, and other biologic
products for use in non-pharmaceutical applications, such as food,
nutrition, and wellness.
With a passion to enable our partners and
collaborators to develop effective preventative and therapeutic
treatments in both developed and emerging countries, Dyadic is
building an active pipeline by advancing its proprietary microbial
platform technologies, including our lead asset DYAI-100 COVID-19
vaccine candidate, as well as other biologic vaccines, antibodies,
and other biological products.
To learn more about Dyadic and our commitment to
helping bring vaccines and other biologic products to market
faster, in greater volumes and at lower cost, please
visit https://www.dyadic.com.
Safe Harbor Regarding Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934,
including those regarding Dyadic International’s expectations,
intentions, strategies, and beliefs pertaining to future events or
future financial performance, such as the success of our clinical
trial and interest in our protein production platforms, our
research projects and third-party collaborations, as well as the
availability of necessary funding. Actual events or results may
differ materially from those in the forward-looking statements
because of various important factors, including those described in
the Company’s most recent filings with the SEC. Dyadic assumes no
obligation to update publicly any such forward-looking statements,
whether because of new information, future events or otherwise. For
a more complete description of the risks that could cause our
actual results to differ from our current expectations, please see
the section entitled “Risk Factors” in Dyadic’s annual reports on
Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as
such factors may be updated from time to time in Dyadic’s periodic
filings with the SEC, which are accessible on the SEC’s website and
at www.dyadic.com.
Contact:Dyadic International, Inc.Ping W.
RawsonChief Financial OfficerPhone: (561)
743-8333Email: ir@dyadic.com
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