ABOUT CYGNUS TECHNOLOGIES
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. In addition, Cygnus now provides innovative viral clearance solutions as well.
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. Cygnus provides analytical tools and solutions delivering insights to improve bioprocess development for faster regulatory approval and better clinical outcomes.
Cygnus is an industry pioneer responsible for developing and commercializing the first generic assay kits for HCP detection. Its reputation for quality is recognized by the industry and global regulatory agencies. It continues to advance the science of bioprocess impurity detection with new breakthroughs, including its Antibody Affinity Extraction™ (AAE) technology and orthogonal methods of HCP analysis that integrate Mass Spectrometry, AAE and ELISA. To reduce the cost and risk associated with viral clearance studies, Cygnus also offers a unique approach that utilizes non-infectious mock virus particles through its MockV™ virus clearance kits.
Cygnus’ proprietary technology, available through its off-the-shelf and custom analytics programs, sets the gold standard for enabling HCP and other bioprocess impurity antibody assays. Cygnus delivers best-in-class customer service and technical expertise, operational excellence and ISO-9001:2015 certified quality management systems.
Founded by Ken Hoffman in 1997, Cygnus continues to support and advance technology in order to improve biotherapeutic safety and accelerate the movement of new therapeutics through the development and regulatory approval process.
Located in Southport, North Carolina, Cygnus Technologies is online at www.cygnustechnologies.com.
This video explains the two different types of HCP ELISA - generic and process specific.
This video explains dilution linearity and spike recovery which are two critical experiments in assessing assay accuracy and specificity.
This video provides an explanation of Host Cell Protein (HCP) ELISA and HCP antibody coverage analysis.
In this video we explain Host Cell Proteins (HCPs) and why they are significant to the development of biopharmaceuticals.
This expert discussion focuses on residual impurities for gene therapy drug products, risk assessment, and characterization of product-related impurities in LVV based gene therapy products.
Explore a case study using a specific HCP immunoassay and advanced orthogonal Antibody Affinity Extraction and Mass Spectrometry methods for assay qualification.
Learn the best practices in HCP immunoassay development, common mistakes and misconceptions , and advanced orthogonal methods of immunoaffinity chromatography and mass spectrometry.
A duscussion on orthogonal methods such as immunoaffinity chromatography and mass spectrometry that enable full understanding of HCPs that could impact patient safety and drug stability.
Discussed here are results from studies that utilized a non-infectious Mock Virus Particle as an MVM surrogate, demonstrating the value to be gained from a QbD approach during process optimization.