At-a-Glance:
| Company |
Cygnus Technologies, part of Maravai LifeSciences |
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| Specialties |
Proprietary immunoassays and orthogonal analytical methods for detecting and characterizing host cell protein and process-related impurities in biotherapeutics. |
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| Mission |
We empower accurate and economical impurity detection, supporting our customers at every stage of their journey toward delivering safe and effective biotherapeutics. |
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| Noteworthy |
Cygnus is an industry pioneer responsible for developing and commercializing the first generic assay kits for HCP detection. |
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| Location |
Leland, NC |
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| Leadership |
Ken Hoffman (Founder) / Christine Dolan (COO & General Manager) |
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Founded over 25 years ago, Cygnus Technologies, part of Maravai LifeSciences, has established itself as an expert in providing highly sensitive process-related impurity analysis tools and services for the biopharmaceutical industry. The company's primary focus is on developing and manufacturing products and analytical methods designed to accelerate the process development phase of biopharmaceuticals while improving their quality, purity, and safety.
Cygnus Technologies recognizes that the reduction of bioprocess impurities to the lowest practical levels requires both sensitive and robust analytical methods. To meet this need, Cygnus offers a full suite of ELISA kits and orthogonal testing services. These are applicable to all current host cell expression platforms and purification process leachates, such as Protein A. These products and services are utilized by many major biopharmaceutical companies, demonstrating their widespread acceptance and reliability as the industry gold standard. More recently, Cygnus’ solutions extend to innovative viral clearance prediction tools as well.
At the core of Cygnus Technologies' product portfolio is their microplate ELISA kits. These well-qualified and convenient-to-use assays are designed to detect host cell proteins from more than 25 recombinant expression systems as well as bioprocess impurities introduced by growth media and during downstream purification.
In addition to off-the-shelf products, Cygnus Technologies provides a broad range of services to help their clients meet regulatory guidelines. These services include process-specific antibody and assay development, leveraging the company's proven host cell protein antibody generation, purification, and assay development technologies. Cygnus works closely with clients to develop, qualify, and manufacture robust kits that meet specific process monitoring, release testing, and regulatory requirements.
Another key service offered by Cygnus Technologies is host cell protein assay qualification. Using state-of-the-art orthogonal methods, such as antibody affinity extraction (AAE), mass spectrometry, and 2D PAGE, the company provides comprehensive antibody coverage analysis in support of qualification of in-house assays or generic kits. This service helps clients meet the expectations of regulators worldwide, ensuring compliance and product safety.
Cygnus Technologies’ analytical tools and services are harnessed at various stages of biologic drug development and commercialization, including prior to human trials, during the regulatory approval process, and for commercial release of biopharmaceuticals. The company’s comprehensive solutions and services have supported the development of numerous commercially approved therapeutics, including therapeutic monoclonal antibodies, recombinant proteins, vaccines, plasma derivatives, and cell/gene therapies.