Sample Testing

ELISA and other orthogonal sample testing for the analysis of assay dilution linearity, spike recovery, and anti-HCP antibody coverage, as well as the identification of downstream host cell proteins that might co-purify with your product.

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Sample Testing by Mass Spectrometry

Identification of host cell proteins by Antibody Affinity Extraction™ (AAE™) and mass spectrometry (MS)  is a highly valuable strategy to ensure that the HCP ELISA is fit for purpose. MS can be used to identify potentially enriched hitchhiker proteins, guide purification process development, and identify HCPs in the final drug substance.

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Sample Testing by ELISA

Demonstration of dilution linearity of samples containing the analyte of interest is a critical experiment to validate the specificity and accuracy of a given method.

Spike and recovery of known amounts of analyte into various sample types is necessary to validate the accuracy of a given method. In some cases, the product protein itself or certain components in the product formulation buffer may interfere in the ability of the assay to detect HCPs or other contaminants.

Sample Testing by AAE™

Antibody Affinity Extraction™ (AAE™) with 2D PAGE or Mass Spectrometry for anti-HCP antibody coverage analysis.

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Sample Testing for Viral Clearance

Gain actionable insights early in process development with Viral clearance validation by MockV® analysis

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Frequently Asked Questions

  • How do I Perform Spike & Recovery Studies?
  • What is "High Dose Hook Effect"?
  • What is Matrix Interference?
  • What is the difference in Sensitivity and Specificity of Western Blot vs ELISA?
  • Why is Dilution Linearity important?

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lf you have questions or would like a quote, a Cygnus Technologies expert is happy to help!

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