Host cell proteins (HCPs) are process-related impurities that are produced by the host organism during biotherapeutic production. Confident removal of HCPs is a key challenge in biotherapeutic development. Read on for expert resources to help support your impurity detection and purification processes.
MAb drugs purification process using resins can lead to ligand leakage although leached protein A concentration in downstream materials is usually very low. It is good practice to therefore demonstrate clearance of leached PrismA in the compound and across each process step to avoid adverse patient reaction to drugs.
Host cell proteins (HCP) are critical to quality control in biologics development. If left unremoved, they can cause immunogenic responses and reduce drug efficacy.
Challenging your assays early can help ensure accurate measurements, build confidence in your results, and reduce the risk of unexpected HCP levels. Explore the comprehensive HCP resources below for further information:
Cytiva and Rockland Immunochemicals, Inc. have collaborated to bring to you robust host cell protein (HCP) assays with a strong security of supply so you can build a foolproof HCP risk mitigation strategy. In this video, Dr. Joe Hirano, Product Manager, Imaging and Western Blotting at Cytiva, and Dr. David Chimento, VP of Custom Services at Rockland, discuss the security of supply for reagents used in HCP analysis.
Maximize the efficiency of your HCP management strategy with the Amersham™ HCP CHO solution
This complete solution is designed to sensitively and robustly quantify and characterize HCP contamination within therapeutics manufactured in Chinese hamster ovary (CHO) cell lines. The solution includes:
Achieve high sensitivity and avoid unexpected HCP levels in later development
The lower limit of detection (LLD) – the lowest concentration that can be distinguished from the background – and the lower limit of quantitation (LLQ) – the lowest concentration that can be measured reliably and reproducibly – have been determined from eight replicates across two plates.
PrismA ELISA™ kit
The only commercial ELISA kit specifically designed for use with Mab Select PrismA resins and resin and Fibro™ PrismA chromatography adsorbers
Avoid unexpected leached PrismA levels in later development
The PrismA ELISA™ kit is capable of detecting low amounts of ligand especially at the final stages of purification. Leached protein A concentration in downstream materials is usually very low. The lower limit of detection (LLD) is the lowest concentration that can be distinguished from the assay background. The lower limit of quantitation (LLQ) is the lowest concentration that can be measured reliable and reproducibly.
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