Residual Host Protein Analysis

Host cell protein (HCP) constitute a major component of the impurities associated with the viral vector manufacturing process. The residual HCP content is often considered a critical quality attribute (CQA) of the product, as HCP has the potential to affect the safety and efficacy of the product. Creative Biogene has advanced analytical equipment and assays to comprehensively monitor the removal of residual HCP from products during bioprocess development, providing efficient HCP testing services to support the production of GMP viral vectors.

Why Should I Conduct Host Cell Protein Analysis Test?

The main risk associated with HCP is immunogenicity. HCPs are complex mixtures with multiple physiochemical and immunological properties. Because of the potential to trigger an immune response in the body, almost all HCPs present a clinical safety risk as foreign protein drug. In addition, some HCPs can act as adjuvants to enhance the immune response to biologic drug products. Certain HCPs with proteolytic activity, if not adequately removed or inactivated, can also affect the stability and efficacy of the drug product. Therefore, the fact that HCPs may affect the safety and efficacy of biologic drugs is the most important reason why we are concerned about HCPs.

Host Cell Protein Monitoring Strategy at Creative Biogene

Creative Biogene's quality control team has developed a comprehensive strategy for residual host cell protein monitoring. In light of these risks and regulatory requirements, our scientists have developed a comprehensive strategy for residual host cell protein detection, which allows for comprehensive analysis of HCPs during the production of viral vectors, taking into account the problems and current state of the art of residual detection methods for HCPs.

Product development is preceded by the use of HCP ELISA kits that have been validated for suitability, including analytical validation of specificity and antibody coverage.
Process-specific HCP services to speed up the product development process and ensure product quality.
Different combinations of methods were used to detect HCPs to make the test results more accurate and comprehensive.
Auxiliary use of proteomics techniques to analyze the residues and composition of HCPs in actual process samples, especially the specific possible high-risk HCPs in them, can effectively improve the accuracy of detection results and ensure product quality and safety.

Methods for Detecting Residual Host Cell Protein

Creative Biogene has developed a variety of methods for the detection of residual host cell protein, allowing for accurate host cell protein detection and analysis.

Method	Description
ELISA	Assays using common commercial ELISA kits eliminate lengthy assay development time and can be used accurately for qualitative detection of HCP.
LC-MS	LC-MS is a popular tool for HCP analysis and can provide direct information on HCP properties (pI, MW, abundance and identification) that can help improve HCP removal strategies in downstream process development.
2D-SDS-PAGE	Complements the HCP ELISA method by providing information on the characteristics of individual HCPs. Highly sensitive and can detect very low abundance proteins.

Creative Biogene is committed to using our advanced methods to test HCP to meet GMP requirements for viral vector release quality control, to facilitate process optimization and to provide our clients with high-quality products. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.

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