We offer unique mass spectrometry services for host cell protein (HCP) analysis of drug samples
Host cell proteins (HCP’s) are the most important process-related impurity in recombinant biopharmaceuticals. Consequently, residual HCP’s may effect drug safety and efficacy, and some HCPs may cause adverse effects in patients. Furthermore, they can impact the stability of the drug substance by proteolytic activity.
Avoid clinical failures of your drug product – identify your host cell proteins
It is important to gain detailed information about the host cell proteins in your sample, because this can help you avoid clinical failures of your drug product. Identification of host cell proteins allows risk evaluation of each individual host cell protein. Hence it can be used in the development of the manufacturing process 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. At Alphalyse, mass spectrometry is used for host cell protein analysis as described in the European and US Pharmacopeia.
Why use host cell protein analysis in early up- and down-stream process development?
Alphalyse recommends mass spectrometry analysis of host cell proteins early in your up- and down-stream process development for:
- Identification of individual HCPs in pre-clinical and clinical batches.
- Monitoring of HCP clearance between process steps.
- For quantification and monitoring of specific HCPs of particular concern.
- For regulatory documentation to FDA, EMA with supplementary documentation of HCP content in clinical batches.
- When applying for marketing approval of your biopharmaceutical.
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.