Author Archives: Helena Nilshans

Rapid HCP Immunoassay Kit Selection: One HCP Kit Does Not Cover All Possible HCP Mixtures

Host cell protein (HCP) levels in biologics are on the critical path for assessing product quality, and they pose a serious risk to drug safety. The challenge is to accurately quantify a complex mixture of HCP impurities, which vary in properties and abundance depending on cell line, media, and process parameters. HCP immunoassay analysis is based on polyclonal antibodies raised against HCPs from nontransfected cell lines. How well a particular HCP assay recognizes all proteins depends on how well the…

Data-Driven Decisions to Maximize Productivity Using Automated Immunoassays in Clone and Bioprocess Development

High productivity in bioprocess development demands efficient bioanalytical procedures to measure clone expression, product titer, and process impurities. Commonly used methods such as enzyme-linked immunosorbent assay (ELISA) or high-performance liquid chromatography (HPLC) can create bottlenecks in critical workflows due to limitations in throughput, performance, and time to results. Read the full text of this application note in the PDF (Login required).