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Host Cell Proteins (HCP) Detection
The removal of Host Cell Proteins (HCPs) is a critical component of any biopharmaceutical purification scheme as residual HCPs remaining in the final drug product can have significant adverse effects on the potency and safety of a biotherapeutic. Therefore, detection and quantification of residual HCPs is typically a Critical Quality Attribute (CQA) and one of the key Quality Control release measures for in-process samples and drug substance (DS). The WuXi Biologics Center of Excellence for Host Cell Proteins Detection provides full in-house HCP detection services for early and late-stage CMC projects, all supported by our state-of-the art analytical equipment and methods. We work together with our in-house QC team to support late-stage HCP removal process validation studies as well as assay validation, and have expertise developing process specific assays in addition to our highly-vetted WuXia CHO-K1 platform assay for DS release. Our HCP detection assays have gained regulatory agency approvals for a wide variety of marketed biotherapeutics and vaccines.
Our HCP-Related Services Include
- Platform CHO-K1 HCP ELISA for projects in early or late-stage projects
- Coverage evaluation of HCP antibodies for specific upstream process
- HCP characterization for in-process samples by Mass Spectrometry
- Process Specific HCP ELISA development
Platform HCP assays can be utilized and offer advantages when compared to process specific assays for both early- and late-stage programs as detailed in USP (U.S. Pharmacopeia National Formulary, USP 39 Published General Chapter, <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals, 2016). The WuXi Biologics Center of Excellence for HCP Detection originally developed a platform HCP assay for our WuXia CHO-K1 cell line. However, the breadth and depth of HCP antibodies coverage is so great that our platform assay is ideal for any CHO-K1 cell line used for biologics production. The performance our platform HCP assay is equal or greater than commercially available HCP detection kits. Our CHO-K1 platform HCP assay is ready-to-use and has gained FDA approvals for multiple commercially available biologics.
- We utilize 2D gel and 2D Western Blot methodologies for the evaluation of HCP antibody coverage in our platform HCP assays or for specific HCP assays we develop for our clients
- Null cells are typically used for HCP generation and subsequent harvest from a bioreactor run, although we have also used harvested cell culture fluid (HCCF) where and when applicable.
For in-process samples, we provide HCP identification by LC-MS as an orthogonal method.
We provide process specific HCP services to meet your project needs. All specific HCP method development (Figure 1) starts with null cell construction and finishes with ELISA assay development, qualification and validation (if required). HCP-specific assays also require newly generated HCP standards, HCP antibodies, and HRP-conjugated antibodies and our extensive in-house protein generation labs help support these efforts.
Contact us to learn more about our HCP detection services and our other Centers of Excellence.