Products
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
? Assay standard preparation
Comprehensive studies (concentration, composition, stability, traceability, etc.) and production
? Antibody preparation
Effective immunization strategies, and antibody tier & coverage validation
? Kit Development
Assay set-up and product specification setting
? Production Validation
Pilot scale test and process scale-up validation
? 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.
