Host cell proteins (HCPs) are contaminants found in biopharmaceuticals expressed in bacterial, yeast or mammalian production cell lines. Among protein expression cell lines, Chinese hamster ovary (CHO) cells are the most commonly used mammalian hosts for industrial production of recombinant protein therapeutics. However, manufacturing and production processes of biopharmaceuticals often leave behind contaminating HCPs from CHO cells. These residual HCPs carry substantial risk of decreasing efficacy of the drug and causing adverse immunogenic reactions in patients. Hence, detecting residual HCP contaminants and methods to reduce them to the lowest acceptable levels are critical aspects of drug safety and qualification.
ForteBio LLC and Cygnus Technologies have jointly developed the Anti-CHO HCP Detection Kit for quantitation of residual HCPs. The Octet® platform's rapid high-throughput protein analysis combined with the broad HCP recognition and sensitivity of the industry-standard Cygnus 3G anti-CHO HCP antibody bring scientists the best of both worlds for HCP analysis.
Key Kit Benefits
- Completely hands-off, walk-away HCP analysis
- Fully analyzed HCP results for 96 samples in one hour
- High precision assays with 5-10% CVs
- Detection sensitivity as low as 0.5 ng/mL
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Among current HCP analytical methods, ELISA is the most commonly used. However, ELISA's highly manual processing steps introduce data variability and multiple time-consuming incubation steps are required. Octet systems automate the entire process to drastically improve assay precision and need minimal user intervention. A completely hands-off, walk-away HCP assay run on the Octet HTX system provides fully analyzed results for 96 samples in one hour, compared to three with ELISA. Assays run on other Octet systems with the Sidekick Station provide time to results of 75 and 90 minutes, respectively.
| Assay Parameter |
Cygnus 3G ELISA Kit |
ForteBio-Cygnus Anti-CHO HCP Kit |
| Time-to-Result |
210 min |
- 62 min on Octet HTX system
- 75 min on Octet RED384 system with Sidekick Station
- 90 min on Octet RED96 system with Sidekick Station
|
| Dynamic Range |
1-100 ng/mL |
0.5-200 ng/mL |
| Precision |
15-25% |
5-10% |
|
Table 1: Comparison of overall assay performance for HCP analysis on Octet systems and ELISA for 96 samples.
Figure 1: HCP quantitation on the Octet QKe system. Example data from the duplicate analysis of three unknown samples run in serial dilution (top). Calculated concentrations and %CV values are shown in the accompanying table (bottom). The dilution linearity graphs for Sample 1 and Sample 2 are shown (middle).
Figure 2: Sample data from a major US pharmaceutical company, in which the results from Anti-CHO HCP Kit confirmed prior sample data obtained from SDS-PAGE showing the near complete removal of HCP from a process sample. Lane 5 data represents the sample before it was run through a purification column, lane 6 is the sample data post-purification.