Within biopharma industry there is a lot of regulation required to ensure the safety of biopharmaceuticals prior to human use. Cygnus Technology is a pioneer in developing Host Cell Protein and other process-related impurity assays for the fields of cell and gene therapy and vaccine development. They have also developed mock virus particles for checking viral clearance. HCP kits from Cygnus are an industry standard recognized by the global regulatory authorities.
Cygnus has developed ELISA kits for over 50 different expression systems, for mammalian, yeast, transgenics, insect and bacterial cells. Host cell protein and bioprocess impurity ELISA kits contain 96-well strip format plate and all the materials needed for ELISA testing, in ready-to-use format.
Host Cell DNA Kits
Cygnus host cell DNA detection kits utilize PicoGreen® DNA binding dye and proprietary DNA extraction reagents and cell-line specific DNA calibrators. The PCR amplification kits contain DNA extraction reagents, DNA calibrators, and validated specific primers, but not the PCR master mix for qPCR.
Viral Clearance Kits
Viral vectors are often used in production of various cell and gene therapy products. Viral clearance validation before clinical trials can be assessed through spiking studies with model viruses and viral quantity is then checked pre and post-purification. This work requires higher biosafety laboratories and specialized personnel. MockV-kits contain non-infectious virus-like particles, which can be handled in BSL-1 level laboratories for easy and economical viral clearance studies.