BioGenes Launches Ultra-Sensitive CHO CTSB ELISA Kit

Precise Detection for High-Risk Host Cell Proteins

BioGenes has introduced a new CHO CTSB ELISA Kit designed for ultra-sensitive detection of Cathepsin B (CTSB), a high-risk host cell protein (HCP) commonly encountered in CHO-based biopharmaceutical production. This targeted ELISA assay enhances monitoring precision, enabling tighter control over product stability and quality.

Critical Monitoring of High-Risk HCPs

In CHO bioprocessing, certain proteases like CTSB can degrade therapeutic proteins, compromise potency, and increase immunogenicity risk even at very low concentrations. Generic HCP assays may fail to detect such high-risk proteins with sufficient sensitivity, creating gaps in process monitoring. The new BioGenes CTSB ELISA Kit addresses this by delivering highly specific and reliable CTSB quantification.

Ultra-Sensitive ELISA Performance

The BioGenes CHO CTSB ELISA Kit offers performance tailored to modern biopharmaceutical workflows:

• Ultra-sensitive detection with a limit of detection around ~0.039 ng/mL.

• Broad dynamic range spanning ~0.3125 – 20 ng/mL for thorough sample analysis.

• Regulatory-aligned qualification according to ICH Q2(R2) guidelines for dependable data.

• High specificity with minimal cross-reactivity, enabling clearer interpretation of HCP profiles.

Enhanced Process Understanding

Built with high-quality polyclonal antibodies, the CTSB ELISA Kit integrates seamlessly into existing quality control workflows, supporting detection in both in-process samples and final drug substances through standard ELISA readers. This precision tool empowers manufacturers to detect and manage high-risk HCPs more effectively, reducing regulatory challenges and strengthening product safety.

Key Features

• Dedicated CHO CTSB ELISA for high-risk HCP monitoring

• Ultra-sensitive detection down to ~0.039 ng/mL

• Wide quantification range for versatile sample analysis

• ICH Q2(R2) compliant method qualification

Applications

• CHO bioprocess host cell protein monitoring

• Process development and optimization

• Quality control in biologics manufacturing

• Regulatory submission support

• High-risk HCP tracking in upstream and downstream workflows

Strengthening Bioprocess Analytics

BioGenes’ new CHO CTSB ELISA Kit reinforces the company’s commitment to specialized HCP detection solutions, enabling biopharmaceutical producers to enhance both process robustness and product quality. By offering targeted analysis of critical HCPs, the assay supports deeper understanding and risk control throughout the biologics lifecycle.