Ensure the purity and safety of your biotherapeutics, from process development to clinical manufacturing to commercial product lot release. Produce your best with Cygnus, the leader in bioprocess impurity detection and analytics.
Detect and measure host cell proteins from 24 cell culture production platforms.
Detect and reproducibly quantify residual Protein A, Protein L and other process-related impurities.
Extract and quantify host cell DNA with your real-time PCR instrument of choice.
Assess viral clearance of downstream purification steps in your BSL-1 lab, on your own timeline.
Evaluate immunoreactive HCPs by Antibody Affinity Extraction (AAE™) combined with Mass Spectrometry (MS) or 2D-PAGE.
Assess DS purity and efficacy of your purification process with our MS-based HCP quantification platforms.
Process-specific HCP ELISA kits to meet your product release testing and regulatory guidelines.
Dilution linearity, spike and recovery, interference, precision, and antibody coverage studies to establish HCP ELISA fit for purpose.
RVLP or MVM spiking studies provide actionable insights early in process development.
Preclinical to phase 1 clinical
Demonstrating effective removal of impurities introduced during cell culture and downstream purification is required to ensure downstream process consistency and purity of the final drug substance.
Phase 1 & phase 2 clinical
Qualifying impurity detection methods for your purification process is required by regulatory agencies prior to clinical use. Our experienced team can provide support with antibody coverage analysis, assay qualification, and sample testing services to ensure your assay is fit-for-purpose.
Phase 3 to BLA
Decide whether developing a custom process-specific impurity detection assay will best meet your needs throughout the drug’s lifecycle. Validate your chosen assay using dilution linearity, spike & recovery, coverage analysis, robustness and repeatability. Our expert scientists can perform a variety of assessments to determine HCP antibody coverage and identify problematic HCPs that may co-purify with your product.
Commercial manufacturing
Decide whether developing a custom process-specific impurity detection assay will best meet your needs throughout the drug’s lifecycle. Validate your chosen assay using dilution linearity, spike & recovery, coverage analysis, robustness and repeatability.
in Host Cell Protein analytics. Our customers have been trusting their results from our HCP assays for over 25 years.
A reliable partner with HCP and other bioprocess impurity assays accepted by global regulatory agencies.
in developing advanced orthogonal HCP characterization methods: Antibody Affinity Extraction and Mass Spectrometry
