Host cell proteins (HCPs) produced or encoded by the organisms are unique to their respective hosts (types and strains) used for biologics production. Due to their potential impact on product quality and efficacy as well as patient safety, the total amount of residual HCP in a biological drug substance generally is considered a critical quality attribute (CQA) that usually needs to be tested for during batch release. Commonly HCP presents in small quantities (parts per million expressed as nano grams per milligrams of the intended recombinant protein). The sandwich immunoassay, designed with polyclonal antibodies, is the workhorse of HCP monitoring and quantitation. This assay format offers a combination of high sensitivity, specificity, throughput, automation potential, rapid turnaround, quantitative results, and low cost per assay that is unmatched by any other currently available assay technology. HCP quantitation kits produced by ExCellBio are type of generic assays using the combination of upstream isolates and corresponding polyclonal antibodies as the major ELISA assay components.
The ResiQuant® CHO HCP ELISA KIT-FAST is a simple-to-use and quantitative ELISA kit for CHO HCP. The limit of detection (LOD) for this kit is 0.5 ng/mL, and the limit of quantitation (LLOQ) is 1.0 ng/mL.
The ResiQuant® HEK 293 HCP ELISA Kit is a simple-to-use and quantitative ELISA kit for HEK 293 HCP. The limit of detection (LOD) for this kit is 5 ng/mL, and the limit of quantitation (LLOQ) is 10 ng/mL
The ResiQuant® E. coli HCP ELISA Kit-Plasmid is a simple-to-use and semi-quantitative ELISA kit for E. coli HCP in plasmid using the alkaline lysis process. The limit of detection (LOD) for this kit is 0.5 ng/mL, and the limit of quantitation (LLOQ) is 1.0 ng/mL
| Item No. | Product | Site | Term of validity |
|---|---|---|---|
| CRH00-3051/3052 | ResiQuant® CHO HCP ELISA Kit -FAST | 48T/96T | 12 months |
| CRH00-3031/3032 | ResiQuant® Ready-to-use CHO HCP ELISA Kit 2G | 48T/96T | 18 months |
| CRH00-3041/3042 | ResiQuant® E.coli HCP ELISA Kit-Plasmid | 48T/96T | 18 months |
| CRH00-3061/3062 | ResiQuant® HEK 293 HCP ELISA kit | 48T/96T | 12 months |
Double quality checks before being released to the market
| Performance | CHO | E．coli | HEK293 |
|---|---|---|---|
| Range | 1-250 ng/mL | 1-250 ng/mL | 10-1000 ng/mL |
| Linearity (R2) | ≥0.99 | ≥0.99 | ≥0.99 |
| Accuracy | ±20% | ±20% | ±20% |
| Repeatability | ≤15% | ≤15% | ≤20% |
| Intermediate Precision | ≤20% | ≤20% | ≤25% |
| Spike Recovery | 70%-130% | 70%-130% | 70%-130% |
| Method | One-step | Two-step | Two-step |
| Calibrators | Ready-to-use | Lyophilized powder | Lyophilized powder |
A: CHO HCP pre-AAE and post-AAE Wayne chart
B: CHO HCP Virtual 2D-PAGE based on mass spectrometry identification (MW vs. pl)
Polyclonal antibodies were characterized by Affinity Extraction (AAE) and Mass Spectrometry
(See the picture above for specific data↑)
AAE-MS analysis revealed that the CHO HCP impurities captured by the corresponding antibodies of CHO HCP ELISA kit included 69 widely existing host cell protein groups, among which 22 groups were identified as highly risk impurities.
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