Do you want to determine the process-related impurities in your biologic?
Alphalyse offers the most detailed HCP analysis on the market. Where most suppliers offer ELISA, 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:
- BIOPROCESS: Analysis for bioprocess optimization >
Identification of HCP 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. Than thus be used as documentation of HCP clearance for PAT and process validation,
- SPECIFIC HCPs: Quantification by MRM >
Identification and feature analysis of HCPs 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.
- COVERAGE ANALYSIS: Validate your 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 ELISA fits your drug product.
- RESIDUAL PROTEINS: Analysis of process-related residuals >
Evaluation of specific proteins added in the manufacturing process to produce the protein of interest.