Do you want to determine the process-related impurities – or residuals – in your biologic?
Alphalyse offers the most detailed Host Cell Protein detection analysis on the market. Where most suppliers offer ELISA kits or ELISA antibodies, our services are based on SWATH LC-MS to provide total HCP content (ng HCP/mg DS) in each sample.
In addition, you get identification and quantification of each individual host cell protein. All in just 8-12 weeks!
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Our experts in HCP analysis by mass spectrometry can help you in the following areas:
- COVERAGE ANALYSIS: Validate your HCP ELISA assay >
Validation of HCP coverage of generic or process-specific ELISA polyclonal antibodies. Can thus help you evaluate how well a commercial kit or generic Host Cell Protein ELISA fits your drug product.
- BIOPROCESS: Analysis for bioprocess optimization >
Detection of Host Cell Protein in each process sample, and physical properties of each HCP (amino acid sequence, MW, pI, hydrophobicity). This enables a comparison of process steps.
- CLINICAL BATCH: Analysis of pre-clinical and clinical batches >
Identification of HCPs in GMP batches, as well as absolute Host Cell Protein quantification. Can thus be used as documentation of HCP clearance for PAT and process validation,
- SPECIFIC HCPs: Quantification by MRM >
Identification and feature analysis of Host Cell Protein in drug substance. Moreover, monitoring and quantification of specific HCPs of concern based on your risk assessment.
- BIOSIMILARS: Comparison of biosimilar and originator >
Quantification and identification of individual HCPs in biosimilar and originator products. It is also possible to look into multiple lots/batches of product to evaluate the production process.
- RESIDUAL PROTEINS: Analysis of process-related residuals >
Evaluation of specific proteins added in the manufacturing process to produce the protein of interest.
Click the links above for more information. You are also welcome to send us a request with a description of your HCP analysis project, so we can tailor your project proposal.
Convenience above all