Dyadic and Cygnus Technologies Announce Partnership To Provide C1 HCP ELISA Assay to Enhance Quality Assurance in Biomanufacturing
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The strategic partnership between Dyadic International and Cygnus Technologies to develop the C1 HCP ELISA Kit is a significant advancement for biopharmaceutical manufacturing quality control. Host Cell Proteins (HCPs) are impurities that can affect the safety and efficacy of biologic drugs. The presence of HCPs is a critical concern, as they can provoke immune responses or affect the stability of the drug. The ability to accurately quantify HCPs is therefore essential for ensuring the consistency and purity of biopharmaceutical products.
The C1 HCP ELISA Kit, designed for the proprietary C1-cells filamentous fungus, represents a tailored solution for those utilizing Dyadic's C1 protein expression platform. This specificity could lead to improved efficiency in the biomanufacturing process, potentially reducing costs and time-to-market for new therapeutics. The partnership leverages Cygnus Technologies' expertise in HCP detection, aiming to set a new standard within the industry. As biopharmaceutical companies are under constant pressure to maintain high-quality standards while managing costs, this collaboration could provide a competitive advantage to early adopters of the C1 technology.
The announcement of this partnership may influence investor sentiment towards both Dyadic International and Maravai LifeSciences. The development of the C1 HCP ELISA Kit is poised to enhance Dyadic's value proposition in the biopharmaceutical industry. By offering a more streamlined quality-control process, Dyadic could see an increase in adoption of its C1 technology platform, which in turn may lead to an uptick in revenue.
For Maravai LifeSciences, the collaboration with Dyadic allows Cygnus Technologies to expand its product portfolio and solidify its position as a leader in HCP detection. Given the importance of HCP quantification in regulatory compliance and product lot release, this partnership could result in increased demand for Cygnus's services and products. Investors should monitor the market's reception of the C1 HCP ELISA Kit and any subsequent financial performance indicators from both companies.
Regulatory compliance is a cornerstone in the biopharmaceutical industry. The introduction of the C1 HCP ELISA Kit is a strategic move that aligns with global regulatory expectations for drug purity and safety. Regulatory agencies, such as the FDA and EMA, mandate strict monitoring of HCP levels in biopharmaceuticals. A kit that offers high specificity, sensitivity and reproducibility is essential for meeting these stringent requirements.
The partnership's emphasis on regulatory compliance is not just about meeting current standards but also about anticipating future regulatory scrutiny. As biopharmaceuticals continue to evolve, so too will the regulatory landscape and companies that invest in robust quality-control measures may find themselves better positioned to navigate this changing environment. The collaboration between Dyadic and Cygnus could serve as a model for how companies can proactively address regulatory demands through strategic partnerships and innovative solutions.
JUPITER, Fla. and LELAND, N.C., Feb. 13, 2024 (GLOBE NEWSWIRE) -- 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
+ 1 858-988-5917
ir@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. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: ir@dyadic.com
