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.
Headquartered in Southport, North Carolina, and founded in 1997, 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 and 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 and assay development. Cygnus’ quality management program and processes are ISO-9001:2015 certified.
Product offering
HCP impurity ELISA kits Host cell DNA detection Custom services
HCP & bioprocess impurity ELISA kits
Use these highly sensitive ELISA kits to detect and measure host cell proteins and bioprocess impurities. The kits feature:
- 96-well removable strip microplate format - use only as many wells as you need at any one time
- All the ready-to-use materials you need, including calibrated standards, antibody-coated microplates, conjugate, substrate, and wash buffer
- Excellent precision of <10% CVs - be sure your results are consistent and dependable
- Minimal sample matrix interference from most bioprocess streams.
Cygnus offers ELISA Kits for detecting and measuring various impurities, such as
- Host cell proteins of mammalian, yeast, transgenic, bacterial and insect cell line expression systems
- Protein A
- Process-related impurities such as culture media components
- Species-specific Immunoglobulins
Host cell DNA detection
Benefit from the following features of Cygnus host cell DNA detection kits:
- High throughput: 96 deep-well format facilitates fast processing without having to juggle individual tubes
- Effective co-precipitating reagent: Recover DNA at <1 pg/ml and does not interfere with downstream detection or qPCR assays
- Convenience: 96 deep-well format increases efficiency while minimizing hands-on time
- Speed: Perform 96 individual extractions in under 90 minutes
- Cell line-specific calibrators: Improve host cell detection accuracy and specificity
- Reproducible results: Transfer procedures to other labs with consistent results
- Custom assays: Let Cygnus develop and qualify a residual host cell DNA kit specific to your expression system
Custom services
Tap into the proven antibody generation and purification technologies of Cygnus!
Custom Antibody & Assay Development
Let Cygnus help you develop a robust kit for your specific process, testing and regulatory needs. In order to meet global regulatory requirements, a comprehensive qualification of your custom assay is provided, as well as state-of-the-art orthogonal methods, including their advanced antibody affinity extraction (AAE) method.
Antibody Development
- Custom antigen production & preparation
- Antibody production
- Antibody purification & characterization
The development of poly- or monoclonal antibodies includes immunogen synthesis and conjugation, as well as identification and synthesis of peptide antigens.
Assay Qualification
Get a comprehensive qualification of your in-house assays or generic kits by standard FDA and ICH guidelines, and state-of-the-art orthogonal methods.
- Dilution linearity & spike recovery
- Orthogonal coverage analysis by AAE
- Orthogonal coverage analysis by 2D PAGE
- Orthogonal coverage analysis by mass spectrometry
Sample Testing
Get a sample testing by ELISA and other orthogonal methods for host cell proteins that might co-purify with your product
- by mass spectrometry
- by ELISA
- by AAE
Documentation
| Filename | Download |
|---|---|
| Cygnus - Protein A Mix-n-Go ELISA kit technical sheet |  |
| Cygnus - Multi-method analysis of HCP flyer | |
| Cygnus - Residual host cell DNA analysis tools brochure | |
| Cygnus - Vaccine purity flyer | |
| Cygnus - Antibody affinity extraction service flyer | |
| Cygnus - Products and services flyer | |
