Custom HCP and Other Process Impurity Antibody & Assay Development
Trust our decades of experience to develop your process-specific HCP assay
Cygnus Technologies has a proven track record developing and purifying broadly reactive antibodies to detect HCPs from a range of production platforms, as well as antibodies that detect a variety of chromatography media leachates. With decades of experience and over 150 process-specific and platform HCP Antibodies and HCP ELISA Kits developed for many top-tier biopharma companies, our custom assays support hundreds of biological drug development programs, commercialized biologics, and gene therapies.
25+ Years of HCP Experience
Cygnus rolled out the first HCP kit in 1997, and has continuously built upon that expertise to help deliver gold standard solutions.
200+ Custom HCP Antibodies & Kits
Cygnus has generated process-specific and platform kits/antibodies to support numerous drug development programs
25+ Expression Platforms Supported
From yeast to human, we have the expertise to support your drug manufacturing process.
Our HCP Antibody and Assay Development Capabilities include:
- Proprietary Host Cell Protein antigen processing method combined with optimized animal immunization protocol to ensure broad immune response to all types of Host Cell Proteins
- Choice of animal species to generate best HCP antibody for a given expression platform (mammalian, yeast, insect, bacterial, plant, transgenic animal)
- Consistent and reproducible HCP antibody quality as evident from the coverage analysis by Antibody Affinity Extraction combined with Mass Spectrometry - demonstrating broad reactivity of HCP antibodies and high percentage overlap in identified immunoreactive proteins between different antibody pools.
- Proprietary HCP antibody purification process ensures unmatched antibody specificity and enables development of highly sensitive and specific HCP immunoassays
- Custom assay development and manufacturing according to ISO 9001-2015 quality standards
View our coverage analysis case studies demonstrating:
96% Similarity for two generations of CHO HCP Antibodies
Antibody coverage comparison of polyclonal antibodies supporting the original CHO HCP ELISA Kit, 3G (F550) vs. the resupply CHO HCP ELISA Kit, 3G (F550-1)
91% similarity for two generations of HEK 293 HCP Antibodies
Coverage analysis of anti-HEK 293 HCP antibodies (F650S) to HCPs found in HEK 293 null cell lysate.
82% similarity for two generations of E. coli HCP Antibodies
Coverage comparison of polyclonal antibodies supporting qualification of the 2nd generation E. coli HCP ELISA Kit, 2G (F1020) vs the E. coli HCP ELISA Kit (F410)
Antibody and Assay Development Timeline
With you all the way
Cygnus’ experts will guide you through the decision process and provide regular updates during the development of your custom assay. At the conclusion of your Process-Specific Ab and Assay Development Project, Cygnus Technologies will provide an “Assay Qualification Report” that will serve as the starting point for your follow-on internal validation or CDMO-outsourced assay validation.
Custom Residual DNA Assays
Ensuring elimination of residual Host Cell DNA during biotherapeutic production is another critical step prior to regulatory approval of your drug. Cygnus Technologies uses state-of-the-art real-time PCR assays to detect and quantify femtogram levels of DNA with our off-the-shelf AccuRes™ kits. These high-quality reagents can be built into a customized, sensitive DNA assay for your host cell expression system.
