Robust impurity testing for biotherapeutic development​

Host cell proteins​

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.

Ligand leakage testing

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.

Designing a comprehensive HCP risk mitigation strategy

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:

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Four key considerations to future-proof your HCP strategy​

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Confidence HCP coverage assays with differential gel approaches​

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The importance of validating your ELISAs with coverage assays​

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Answering top questions about challenging host cell protein assays

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How to design a comprehensive HCP risk mitigation strategy

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Coverage analysis without a mock cell line

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The analysis and validation of host cell protein kits
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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.

Solutions to support HCP risk mitigation​

Maximize the efficiency of your HCP management strategy with the Amersham™ HCP CHO solution
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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:​​
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  • The Amersham HCPQuant CHO (supernatant) Kit, an ELISA with broad sample compatibility and high sensitivity​
  • The Amersham Anti-CHO HCP (supernatant) Antibody, a flexible antibody reagent for orthogonal HCP quantification methods
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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.
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  • ​LLD = 1 ng/mL​
  • LLQ = 2 ng/mL
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Solutions for ligand leakage testing

PrismA ELISA™ kit

The only commercial ELISA kit specifically designed for use with Mab Select PrismA resins and resin and Fibro™ PrismA chromatography adsorbers

  • Matched PrismA protein A ligand included in the kit removes the need to separately source standard and create a custom protocol
  • High IgG tolerance simplifies sample preparation
  • Parts per billion sensitivity minimizes the risk of undetected residual PrismA ligand
  • Consistently low intra- and inter-plate variability ensures reproducible data
  • A robust assay with excellent buffer compatibility
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Avoid unexpected leached PrismA levels in later development
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‍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.

Find out more in this free download​

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