David Chimento (Rockland Immunochemicals, Inc., Limerick, PA 19468, LinkedIn)
What is a host cell protein and why is it important in biopharmaceutical manufacturing?
A host cell protein is a contaminant that comes from manufacturing of biopharmaceuticals. Biopharmaceuticals are made using an engineered cell line that produces a therapeutic protein. Often times that can be a therapeutic monoclonal antibody. One of the major issues in the purification of the therapeutic monoclonal are proteins that are contaminating coming from the host cell line.
What is a host cell protein immunoassay and what is it used to monitor?
A HCP immunoassay is a specialized assay that is against all of the proteins of the cell line that is used to manufacture the therapeutic biopharmaceutical. It is a very complicated assay where there is an antibody reagent generated against all of the proteins or as many of the proteins as can be generated against and it is used to monitor in-process consistency in the purification of that molecule. What will happen is during the bioprocessing with multiple different steps samples are be taken in this anti-host cell protein immunoassay will be used to measure the level of total HCP present and it is used to set specifications for that bioprocess.