We offer unique mass spectrometry services for host cell protein (HCP) analysis
Host cell proteins (HCP’s) are the most important process-related impurity in recombinant biopharmaceuticals. HCP’s may effect drug safety and efficacy, and some HCPs may cause adverse effects in patients. HCPs can impact the drug stability by proteolytic and lipase activity. Alphalyse offers identification and quantification of each individual host cell protein, and quantitation of the total HCP content (ng HCP/mg DS).
Avoid clinical failures of your drug product – identify your host cell proteins
Detailed information about the host cell proteins can help to avoid clinical failures and regulatory concerns of your drug product. Identification and quantification of host cell proteins allows risk evaluation of each individual host cell protein and can aid process development to remove HCP’s of concern.
Both FDA and EMA are increasingly aware of the importance of mass spectrometry (MS) as an orthogonal method to ELISA. For biosimilars, the regulatory agencies require that process-related impurities are included in comparability analysis between biosimilar candidate and originator reference product. Alphalyse performs host cell protein analysis as described in the European and US Pharmacopeia.
Use host cell protein analysis early in development of new biologics
LC MS analysis can be applied directly to biopharmaceutical samples and does not require long-term development of ELISA antibodies. HCP analysis by LC MS can be used immediately for development of your novel biologic for:
- Early up- and down-stream process development.
- Monitoring of HCP clearance between process steps to aid process improvement.
- Batch-to-batch comparison of HCP content in pre-clinical and clinical batches.
- For quantification and monitoring of specific HCPs of particular concern.
- For regulatory documentation to FDA, EMA with supplementary documentation of HCP identity and quantity.
Alphalyse develops and provides host cell protein analysis services in the following areas:
- Identification of host cell proteins in each process sample.
- Physical properties of each host cell protein (aa sequence, Mw, pI, hydrophobicity).
- Comparison of host cell proteins between process steps and host cell protein clearance.
- Identification of host cell protein in GMP batches.
- Documentation of host cell protein clearance for PAT and process validation.
- Absolute quantification of specific host cell proteins.
- Identification of host cell proteins of potential concern in drug substance.
- Feature analysis of identified host cell proteins.
- Monitoring and quantification of specific host cell protein of concern based on your risk assessment.
You are welcome to send us a request with your project description. We will then quickly propose an analysis for your project.