Background: Host Cell Proteins (HCPs) are impurities that originate from the host organism / cell lines (e.g., E. coli, CHO, HEK293) used to express recombinant therapeutic proteins, monoclonal antibodies, vaccines, or enzymes. These proteins are produced along with the target biologic and must be efficiently removed during downstream purification to ensure product safety, efficacy, and regulatory compliance.
The KRIBIOLISA Bioprocess Assay Kits available enable researchers to estimate and measure the amount of residual analyte left post downstream purification process. These assays can help identify or characterize the residual analyte which is important in early process and final product release.
This Assay kit is designed to facilitate the identification and characterization of bioprocess analytes used in production and purification.
Assay Features include:
– Ready to use protocol with pre-coated breakapart wells for ease of use
– Standardisation and High Reproducibility
– Lot to Lot Consistency
– Accuracy and Precision
Validated against seven points for a Gold Ring Standard Quality – the benchmark sign for Krishgen quality.
The kits are used for assessing the specific biomarker in samples analyte which may be cell culture supernatant and other biological preparations.
Unlike competitor assays available, we offer pre-coated ready-to-use assays to ensure high level of reproducibility and accuracy and also offer custom assay development which is process specific to comply with FDA needs from our ISO13485 certified factory and labs.
