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Platform CHO HCP ELISA with Superior Performance Characteristics

Our CHO HCP ELISA method can be used to support robust monitoring of HCP clearance through the purification process and quantify CHO host cell proteins (HCP) in purified bulk drug substance samples representing both monoclonal antibodies (mAb) and non-mAb products purified via downstream processes that may or may not include an affinity chromatography step.

Demonstrating process clearance of HCPs is oftentimes challenging for recombinant non-mAb products owing to issues of dilutional non-linearity limitations encountered with HCP ELISA methods. KBI’s unique strategy for pAb generation and detection reagent optimization can alleviate these technical challenges.


Custom HCP ELISA Method Development

We have developed a proprietary library of high-affinity polyclonal antibody (pAb) reagents directed against discrete populations of HCPs derived from a variety of CHO cell lines and fractionated on the basis of molecular mass, charge and hydrophobicity. This pAb library can be customized to generate a CHO HCP ELISA method for addressing molecule-specific process and product-related challenges for HCP clearance.

Customization will include DoE methodologies to optimize HCP coverage analysis and establish acceptable method performance. KBI can also support identification (ID) of HCP species in bulk drug substance (BDS) upon client request, using antibody affinity extraction (AAE) methodology and LC-MS/MS.


HCP Diagnostic Tools to Support Purification Process Development

KBI can also format a CHO HCP ELISA method for diagnostic use to categorize in-process CHO HCPs associated with a downstream process. This diagnostic kit will leverage KBI’s library of proprietary CHO HCP pAb reagents, and can be used to guide optimization of the purification process for HCP clearance capability.

If HCP clearance remains problematic, KBI can assist with identification of CHO HCP populations among in-process samples from specific chromatography unit operations by LC-MS/MS analysis, which can be performed using either neat samples or samples. Identification of problematic host cell protein(s) can assist with chromatography resin selection and support development of optimized column loading, wash, and elution conditions for HCP clearance.