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Custom Development Services

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Scientists at Cygnus Technologies have many years of experience in developing immunochemical reagents and methods for analytical research and human and animal diagnostic applications. Cygnus specializes in custom antibody and assay development for host cell protein detection in recombinant pharmaceuticals. Utilizing our proprietary technologies for the generation and affinity purification of sensitive and broadly reactive polyclonal antibodies, we have successfully developed ELISA to more than fifty different recombinant expression systems, including bacteria, various yeasts and human, mammalian cell lines as well as transgenic and plant expression systems. Through our extensive networking with other high quality special technology companies, we have the ability to integrate and manage projects requiring highly diverse technical inputs. Some of the specific services we offer are listed below.

  • Custom antibody development - of polyclonals or monoclonals to include synthesis and conjugation of immunogen and the identification and synthesis of peptides to serve as antigens.
  • Antibody Affinity Extraction (AAE) - AAE overcomes most of the limitations of 2D WB while enabling the determination of coverage to the most relevant host cell proteins (HCPs)—those that co-purify with your product. Traditional attempts to determine anti-HCP coverage by comparing a non-specifically stained 2D PAGE to WB provide very little predictive value in determining how the ELISA using that antibody, will quantitatively react to the more limited array of HCPs in downstream samples. We conduct AAE for antibody coverage analysis and AAE for Mass Spectrometry identification of individual HCPs.
  • Antibody purification and conjugation - Antisera can be bulk-purified to yield crude IgG fractions or affinity-purified to yield highly specific antibody activity. We also have extensive expertise in the development and manufacture of various conjugated forms of antibody such as intact and Fab2 antibody molecules to various labels such as Alkaline Phosphatase, Horseradish Peroxidase, and Biotin.
  • Custom assay development - We have successfully developed immunoassays on a wide range of assay formats from manual ELISA methods to high throughput automated immunoassay systems. Our current menu includes 25 assays for host cell protein analysis. These tests can be custom modified for your specific sample matrix and any special analytical requirements that you may have. Should our "generic" kits not fulfill all your analytical needs, we can custom affinity purify our broadly generic antisera against your process specific contaminants, recalibrate the test with those same process specific contaminants and in this way assure that you have a highly specific and sensitive assay, capable of meeting FDA and international regulatory body requirements for bioprocess contaminant testing.
  • Bioprocess development and quality control - Our expertise is designed to save time and money by avoiding needless duplication of these specialized skills within a biotechnology client company. We can advise you on the best scale-up process, as well recommend and develop analytical methods and tools to be used in the determination of product purity.

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