CTSB ELISA Kit
High-Risk HCP Detection in CHO-Derived Biologics
Even trace levels of active Cathepsin B (CTSB) can silently compromise biologics by driving product fragmentation, potency loss, and increased immunogenicity risk. The BioGenes CTSB ELISA kit enables sensitive, targeted detection of this high-risk host cell protein in CHO-based biopharmaceutical production, helping you protect stability, safety, and regulatory compliance.
Why Cathepsin B (CTSB) is a High-Risk HCP in Biologics Manufacturing
Cathepsin B (CTSB) is a lysosomal cysteine protease widely expressed across most cell types. It plays a central role in intracellular protein turnover, cellular stress response, and detoxification, and has been extensively studied as a biomarker in oncology and disease research.
In CHO-based biopharmaceutical manufacturing, lysosomal proteases such as CTSB are increasingly recognized as critical high-risk host cell proteins (HCPs):
Product degradation
Active CTSB can cleave therapeutic proteins during manufacturing and storage, eroding stability, potency, and shelf-life even at very low concentrations.
Immunogenicity risk
As an endogenous immune modulator, particularly in tumor-associated microenvironments, residual CTSB may exacerbate patient immune responses and contribute to unwanted immunogenicity.
Regulatory expectations
Because of its strong proteolytic activity and dual risk profile (degradation + immunogenicity), regulators increasingly expect targeted monitoring and quantification of high-risk proteases like CTSB, as a complement to generic HCP assays.
Targeted CTSB monitoring enables you to identify risk early, refine your process, and generate stronger data packages for regulatory submissions.
BioGenes CTSB ELISA Kit: Principle and Advantages
BioGenes offers a dedicated CTSB ELISA kit specifically designed for sensitive and reliable detection of Cathepsin B in CHO-derived biologics.
CHO-relevant antigen, minimized cross-reactivity
The assay is based on recombinant CHO-derived CTSB expressed in HEK293 cells, ensuring high antigen quality while minimizing the risk of cross-reactivity with other CHO host cell proteins. This makes the assay highly relevant for real-world CHO production processes.
Broad epitope coverage for robust detection
For detection, the kit employs high-affinity polyclonal antibodies. Unlike monoclonal antibodies, which bind a single epitope and may fail to recognize structurally altered native CTSB, polyclonal antibodies target multiple epitopes. This broader epitope coverage supports:
- Reliable recognition of native CHO CTSB
- Increased robustness against structural variants
- Consistent detection across different process conditions
This comprehensive binding profile contributes directly to the high sensitivity and robustness of the CTSB-HCP ELISA.
Assay performance tailored to high-risk HCP monitoring
- Limit of detection (LOD): ~0.039 ng/mL
- Working range: 0.3125 – 20 ng/mL
Method qualification: CTSB-HCP ELISA is qualified according to ICH guideline Q2(R2), providing a solid basis for further validation and regulatory use.
These performance characteristics make the BioGenes CTSB ELISA kit a powerful tool for high-risk HCP monitoring in process development, comparability studies, and routine QC.
Ready to get CTSB under control?
Order the CTSB ELISA kit or contact our experts to discuss integration into your high-risk HCP strategy.
