Custom development services

Put decades of our technical expertise in Host Cell Protein analytical solutions on your team! Cygnus technical experts will qualify a generic HCP ELISA for your specific process according to standard FDA and ICH guidelines:

• HCP antibody coverage analysis services are performed in a state-of-the-art Chromatography and Mass Spectrometry Laboratory featuring our AAE™ method coupled with 2-dimensional polyacrylamide gel electrophoresis (2D-PAGE) or mass spectrometry (AAE-MS™) for identification of immunoreactive HCPs
• Qualification of a generic HCP ELISA for your specific process according to standard FDA and ICH guidelines, including dilution linearity, accuracy by spike and recovery analysis, assay precision, and range
• Custom HCP assay development: With over 200 process-specific and platform HCP Antibodies and HCP ELISA Kits developed for many top-tier biopharma companies, Cygnus custom assays support hundreds of biological drug development programs, commercialized biologics, and gene therapies. Cygnus’ experts will guide you through the decision process and work closely with your team during the development of your custom assay.

BSL-1-compatible viral clearance prediction studies

Cygnus MockV^® Viral Clearance Prediction Services help assess viral clearance early in process development. Through a unique solution that utilizes BSL-1 compatible virus-like particles, Cygnus MockV Team can ease the burden on your staff and perform analysis of samples generated by your in-house MockV spiking study (RVLP or MVM).