Take Control of HCP Residues with High-Performance ELISA Kits

Overview

During the production of biologics such as recombinant proteins, monoclonal antibodies, and vaccines, host cell proteins (HCPs) are one of the main sources of process-related impurities. Residual HCPs may trigger immune responses and affect the stability and efficacy of drugs. Therefore, the detection and control of HCPs have become a key focus of global regulatory authorities.

Authoritative organizations such as the International Council for Harmonisation (ICH), United States Pharmacopeia (USP), and European Pharmacopoeia (EP) clearly require the use of highly sensitive and validated methods to monitor HCP residues and ensure drug safety and control.

How can HCP residues be detected efficiently and accurately? We present two high-performance ELISA kits—E. coli HCP and CHO HCP Residual Detection Kits—to help you easily address HCP testing challenges.

Why Is HCP Residue Detection Necessary?

HCPs originate from expression systems (such as E. coli and CHO cells) and may remain in the final product during cell disruption and purification processes. Their presence poses potential risks to drug safety and quality, making HCP control a mandatory requirement by global regulatory authorities.

01 Immunogenicity Risk

HCPs are a mixture of various proteins that may induce anti-HCP antibodies, triggering immune responses in the human body such as fever, edema, or even shock. In addition, HCPs may act as adjuvants, promoting the formation of anti-drug antibodies and enhancing the immunogenicity of biologics.

02 Product Aggregation or Degradation

Proteolytic HCPs (such as cathepsins, serine proteases, and metalloproteinases) may hydrolyze or degrade target recombinant proteins, leading to product degradation or aggregation. Lipase-family HCPs can degrade commonly used stabilizers such as polysorbates, thereby affecting drug stability and safety.

03 Regulatory Requirements

Major global pharmacopoeias and regulatory agencies have established clear requirements for HCP residues:

United States Pharmacopeia (USP): Chapter <1132> states that HCP levels in drug products should be below the detection limit of a sensitive method (typically <100 ppm, i.e., less than 100 ng HCP per 1 mg total protein, or <0.01%).

ICH Q6B: The guideline requires the use of sensitive and validated methods to monitor residual HCPs, with typical limits below 100 ppm.

European Pharmacopoeia (EP): EP 2.6.34 specifies that HCP content in biologics should be less than 0.1%.

Chinese Pharmacopoeia: For CHO cells, HCP residues must be <0.05% (equivalent to <500 ppm); for E. coli, <0.01% (equivalent to <100 ppm).

E. coli HCP Residual Detection Kit (ELISA) (Cat. No. HBP003907)

01 Product Overview

Developed in-house by Hzymes, this kit uses a double-antibody sandwich method combined with a biotin-streptavidin signal amplification system to enable one-step quantitative detection of E. coli HCP in samples. It offers high sensitivity and a wide linear range (3–300 ng/mL).

02 Key Advantages

High Coverage: Identified by LC-MS/MS and AAE-MS™, with antibody coverage exceeding 85%.

High Sensitivity: Limit of detection (LOD) < 0.5 ng/mL; limit of quantification (LOQ) 3 ng/mL.

Accurate and Reliable: Coefficient of variation (CV) < 10%; recovery rate 80%–120%.

Easy Operation: Simple workflow and straightforward standard curve generation.

High Specificity: No cross-reactivity with HCPs from other cell types and no interference in E. coli HCP detection.

Good Compatibility: Optimized formulation ensures excellent compatibility with various sample matrices, with good linearity and spike recovery rates of 80%–120%.

Hzymes E. coli HCP Residual Detection Kit (ELISA)

Other Similar Products

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CHO HCP Residual Detection Kit (ELISA) (Cat. No. HBP003905)

01 Product Overview

Developed in-house by Hzymes, this kit uses a double-antibody sandwich one-step method to detect CHO HCP levels with high sensitivity and accuracy across different stages of biologics manufacturing.