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.
Host Cell Protein (HCP) Immunoassays And Role Of Mass Spectrometry In Identification Of HCP Impurities In Downstream Samples
How can you better identify those host cell proteins (HCPs) that might co-purify with your drug substance (DS) and elicit an undesired immune response, interfere with drug safety and efficacy, or impact DS stability? Cygnus Technologies VP of R&D, Eric Bishop, discusses powerful orthogonal methods such as immunoaffinity chromatography and mass spectrometry that enable full understanding of those HCPs that are present in the product and could potentially impact patient safety and drug stability.
A discussion on orthogonal AAE and Mass Spectrometry methods used to assess ELISA Ab coverage to HCPs present in a process, and identifying process-specific HCP that may co-purify with a drug substance.
A broadly reactive and well-qualified HCP ELISA is critical for monitoring purification process consistency and final drug substance purity. Here we present an overview of assay qualification steps.
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.