In biopharmaceutic manufacturing the term host cell proteins (HCPs) clusters proteins derived from the host organism. Host cells are manipulated to express the protein of interest however they still pursue their normal endogenous expression pattern, resulting in a heterogeneous protein mixture.
HCPs are regarded as process related impurities for monoclonal antibodies, antibody-drug-conjugates, therapeutic proteins, and other protein-based biopharmaceuticals.
Consequently, quantitation and removal of HCPs in the final drug product to acceptable low levels is essential. Purification of the drug from HCP contaminants presents a demanding challenge, especially with low-level contamination remaining after purification. Remaining impurities accompanied with recombinant biotherapeutics can significantly affect drug efficacy and cause immunogenicity.
This site provides an overview for scientists and manufacturers of HCP in recombinant protein production with strategies for detection quantification and removal of HCP impurities. An overview presents the most important host species and their respective perks. Different approaches for detection and their orthogonal interplay are outlined in order to obtain the highest HCP coverage rate possible. In addition, the advantages and limitations of commonly applied methods will be discussed.
Here you will find information on what HCPs are and what problems they may cause in biopharmaceutical processes.More
An important point in biopharmaceutical development processes is regulation. Here we present the most important regulatory authorities.More
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