Host Cell Protein analysis

Get full identification and quantification of your HCP without limitation due to the use of antibodies

Generic immunoassay does not suit to your project
You work with "exotic" cell lines
Optimise your Down Stream Process (DSP)
Individual amount of all Identified HCP

The coverage you obtain does not meet your expectation or major HCPs are not quantified with commercial kits. With LC-MS approach, you obtain full identification of HCPs independently of antibody reagents.
No commercial kits are available. Database we use allow us to work on the cell line of your choice.
With the list of identified HCPs, we give you information of physicochemical properties to help you understand each step of your DSP.
Our proprietary technology allows a relative quantification of all identified HCPs to reinforce consistency study and improvement of DSP.

Host cell proteins (HCPs) are common impurities in biologic drug products and are an obligatory critical quality attribute (CQA). The individual protein contaminants that make up the HCP profile, however, may vary significantly among individual biologic products and expression systems. As such, the HCP profile must be analyzed to identify even low levels of potentially concerning species in a biologic drug to ensure safety and efficacy.
Impurities coming from the host, such as Host Cell Proteins (HCPs), may cause immunogenicity and affect drug safety, efficacy and stability. To avoid clinical validation failure, most pharmaceutical companies focus on these host cell proteins impurities for preclinical and clinical batches every biomanufacturing step. Another main challenge for biopharmaceutical drug development is to provide a final top-quality marketed dosage form based on the whole purity of drug substance (therapeutic substance combined with API) as well as the drug product containing excipients.
For regulatory documents, LC-MS has been an orthogonal method to corroborate and supplement Ligand Binding Assays (LBAs) like ELISA. Therefore, ANAQUANT offers innovative and powerful LC-MS expertise and software tools for characterizing your host cells proteins impurities.

Get full identification and quantification of your HCP without limitation due to the use of antibodies

Generic immunoassay does not suit to your project

You work with "exotic" cell lines

Optimise your Down Stream Process (DSP)

Individual amount of all Identified HCP

Batch to batch comparison

Cell line Comparison

Monitoring of Purification steps during DSP

Quantification of specific HCPs

More information about HCPs analysis