Identification and quantitation of HCPs in biopharmaceuticals
Do you want to determine the process-related impurities in your biologic?
Alphalyse offers a range of unique Host Cell Protein analysis services, and the most detailed HCP analysis on the market today. The services are based on SWATH LC-MS that provides identification and quantification of each individual protein, as well as the total HCP content (ng HCP/mg DS) in each sample.
Do you know the HCPs in your biopharmaceutical? Read below, the services tailored for specific purposes and in addition this brochure >
We are experts in HCP analysis by mass spectrometry in the following areas:
- BIOPROCESS: Analysis for bioprocess optimization >
Identification of HCP in each process sample, physical properties of each HCP (amino acid sequence, MW, pI, hydrophobicity) and comparison between process steps. - CLINICAL BATCH: Analysis of pre-clinical and clinical batches >
Identification of HCPs in GMP batches, documentation of HCP clearance for PAT and process validation, as well as absolute Host Cell Protein quantification. - 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. Also possible to look into multiple lots/batches of product to evaluate the production process. - COVERAGE ANALYSIS: Evaluation of your ELISA assay >
Validation of HCP coverage of generic or process-specific ELISA polyclonal antibodies. - RESIDUAL PROTEINS: Analysis of process-related residuals >
Evaluation of specific proteins added in the manufacturing process to produce the protein of interest.