Controlling Residual Host Cell Proteins (HCP) Impurities in Biopharmaceuticals
Biotherapeutics must be free of Bioprocess-related impurities, including protein contaminants derived from the Host Cell used as the expression system (bacterium, yeast, mammalian, insect or plant cells). HCP fit the definition of the Critical Quality Attribute (CQA) due to their potential to affect product safety (immunogenicity risk for patients) and efficacy. Regulatory guidelines therefore require manufacturers to monitor the removal of HCP impurities in order to manage these risks.
The challenges HCP pose is reflected in the growing number of publications and scientific conferences devoted to these impurities. The complexity of HCP analysis arises from their heterogeneity. Biopharma companies are therefore advised to manage this risk right from the early phases of the candidate biopharmaceuticals lifecycle development, and to generate a sufficient knowledge to demonstrate control before submitting regulatory filing.
SC8_AM_v1_12-06-2017 Flyer HCP-IDBiotech-EN
Our Custom Solutions
- Expertise for the selection of the commercial generic HCP ELISA kit that best suited to your process specific HCP:
- Evaluation of the dilution linearity with your process specific HCP
- Evaluation of the Limit of Detection and of the Limit of Quantification
- Evaluation of the cross-reaction of your drug substance with the antibodies of the generic ELISA kit
- HCP determination all over your DS purification process
- 2D-Western Blotting analysis for the determination of the coverage of the anti-HCP antibodies (see the article from GE : Coverage analysis to validate HCP ELISA assays)
- Analysis of your sample
- Custom development of HCP ELISA kit specific to your expression system and bioprocess
High Added Value Support for Your Project
- De-risking entry into the clinical phase (drug substance characterized, safety controlled)
- Ensuring compliance of your CMC documents with health authority requirements (FDA, EMA)
- Accelerating your pharmaceutical development stages by supporting the optimization of your bioprocesses
- Helping valorization of drug candidate at various steps (IP, fundraising, licensing)