HZSKBIO^® offers a variety of HCP detection and analysis service platforms:

HCP assay and analysis platform [ELISA, LC-MS, 2D with different staining]

HCP coverage assessment platform [IMBS-2D, IMBS-MS]

Anti-HCP polyclonal antibody preparation platform

Customized HCP ELISA kit development platform

1、HCP Assay and Analysis Service Platform (ELISA, LC-MS and 2D with different staining)

Process-specific SHENTEK^® HCP ELISA kits to ensure accurate and specific detection;

Traceability system for HCP ELISA standards to ensure assay accuracy and reliability;

Process-specific and high-risk HCP analysis, as well as lot-to-lot comparison for preclinical and clinical trial lots;

High-risk HCP identification by applying orthogonal methods to complement the limitations of HCP ELISA for bioprocess development.

Figure 1  Standard Method for HCP Monitoring - Sandwich ELISA Workflow

2、HCP Coverage Assessment Platform (IMBS-2D, IMBS-MS)

Proprietary IMBS (immunomagnetic bead separation) technology using antigen-specific antibody immunoaffinity-purification for rapid & specific HCP immunogen isolation;

Orthogonal proteomic methods of 2D & LC-MS to illustrate antibody coverage of HCPs with increased sensitivity and accuracy;

Antibody coverage analysis on the early process samples or mock samples to select suitable ELISA for the specific bioprocess;

Figure 2 IMBS-2D HCP-antibody Coverage Analysis

Figure 3  IMBS-LC/MS HCP-antibody Coverage Analysis

3、Anti-HCP Polyclonal Antibody Preparation Platform

Effective immunization strategies and antibody preparation for different antigen groups;

Characterization and quality control of antibodies to maximize quality, coverage, and speed;

Antibody generation, purification and screening with optimized processes;

Standard practice of HCP reference traceability to ensure the reliability of immunoassays;

Figure 4  HCP Antigen Preparation and Immunization for Capture Antibody Production

4、Customized HCP ELISA Kit Development Platform

Comprehensive studies of residual HCP (rHCP) standards to achieve excellent coverage and specificity;

Standard practice of HCP reference traceability to ensure the reliability of immunoassays;

Effective and intensive antigen and antibody preparation strategies for robust immune response and high-quality polyclonal antibodies;

Compliance with ISO13485 quality system to guarantee the high-quality HCP ELISA kit development;

Compliance with CNAS/ISO10725 and GMP quality standards to ensure the integrity of the service and products;

HZSKBIO^® Customized HCP ELISA Kit Development Workflow 

❶ Assay standard preparation  

Comprehensive studies (concentration, composition, stability, traceability, etc.) and production
❷ Antibody preparation
Effective immunization strategies, and antibody tier & coverage  validation
❸ Kit Development
Assay set-up and product specification setting
❹ Production Validation
Pilot scale test and process scale-up validation
❺ Method Transfer
Assay validation & transfer test

HZSKBIO^® Comprehensive and Customized Residual Host Cell Protein (rHCP) Analysis Service Platforms

Figure 5   HZSKBIO^® Residual Host Cell Protein Analysis Service Platforms

HZSKBIO has established a highly efficient HCP antigen and anti-HCP antibody preparation and analysis platform, which provides customized process or platform-specific HCP reference standard and diverse antibodies, ensuring the efficient development and consistent supply of high-quality HCP ELISA kits.