Production Overview

Hzymes’ CHO Host Cell Protein (HCP) ELISA kit uses a double-antibody sandwich enzyme-linked immunosorbent assay (one-step method) to quantitatively detect residual CHO HCP impurities in recombinant proteins, monoclonal antibodies, vaccines, and other biotherapeutics.

Key Features

• Ready-to-use plates & standards for easy use.

• One-step assay: only one sample addition and one plate wash before color development.

• Total incubation time: 2 h 15 min.

Product Highlights

• High coverage: >80% coverage confirmed by 2D-WB and AAE-MS™.

• High sensitivity: LOD ≤ 1 ng/mL; LOQ = 3 ng/mL.

• Wide linear range: 3-100 ng/mL (R² ≥ 0.99).

• High accuracy: recovery between 80%-120%.

• High precision: intra-assay CV < 10%; inter-assay CV < 15%.

• High specificity: no cross reactivity with Vero, E. coli, or Pichia pastoris HCPs.

Applications

Assay to accurately measure CHO HCP residues in process intermediates and final products, supporting process development, purification monitoring, and quality control.

Performance Data

High Coverage

>80% coverage confirmed by 2D-WB and AAE-MS™

The blue boxes indicate HCP spots recognized by both kits, while the red boxes indicate spots additionally detected by Hzymes.

Limit of Detection (LOD)

As low as 1 ng/mL and Limit of Quantification (LOQ) as low as 3 ng/mL.

High accuracy and repeatability

CV<10% with spike recovery in the range of 80-120%.

Good data and batch repeatability.

Four samples were tested using kits of three batches.

Good comparability with Cygnus.

Six CHO cell-expressed samples were diluted to the same concentration and tested with Hzymes HBP003905 and CYGNUS F550-1 kits, following respective instructions.

Customer Cases

We have supported numerous customers in their research and development programs across a wide range of biopharmaceutical fields, including monoclonal antibodies, recombinant proteins, vaccines.

FAQ

Is this kit GMP grade or for research use only?

This kit is for research use only, but has successfully been used for several IND application cases in both China and United States.

Does this kit detect HCPs from all CHO cell lines?

The kit has been validated against a broad range of CHO-derived samples. For a new cell line or proprietary process, we recommend performing a spike-recovery test to confirm compatibility.

Can this kit be used for other host cell proteins (e.g., E. coli, HEK293)?

The kit is specific for CHO HCPs. No cross-reactivity was observed with Vero, E. coli, or Pichia pastoris HCPs. For other hosts, please contact us for a suitable kit.