Cygnus Technologies

Your trusted resource for bioprocess impurity analysis

Cygnus Technologies is the leading provider of assays and services for the detection and characterization of impurities, such as host cell proteins (HCP), in biopharmaceuticals. They have an extensive choice of detection solutions for HCP and DNA impurities including ELISA kits, immunoassay reagents and custom development services.

Cygnus builds on innovative, proprietary technology and develops highly specialized analytical products that meet the unique needs of the pharmaceutical, vaccine, gene therapy, and biotechnology industries.

Product offering

  • Highly sensitive ELISA kits for measurement of HCP, Protein A, species-specific immunoglobulin & process-related impurities
  • Reliable and easy-to-use kits and reagents for host cell DNA detection
  • Immunoassay reagents like high-affinity antibodies in various formats (affinity-purified, IgG fractions, neat serum), buffers etc.
  • Western blot kits
  • Immunogenicity analysis kits (research use only)
  • 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