Host Cell Proteins (HCPs) analysis
Host Cell Proteins (HCPs) quantification after purification steps
Bio-therapeutics are generally produced in cells lines such as yeast, bacteria or mammalian cells or even directly in animals. One of the main challenges for Biopharmaceutical production is the purification steps. Contaminants coming from the host, such as Host Cell Proteins, may cause adverse effects in patients.
To avoid clinical failure, it is important to get as much information as possible about these proteins. For regulatory documents, LC-MS has been used as an orthogonal method to LBAs and ELISA.
Identification and quantification of HCPs can be set-up in your pre-clinical phases but also through your Upstream and Downstream step.
In ANAQUANT we offer customized assay development to identify and quantify HCPs to:
- Generate HCPs lists in pre-clinical and clinical batches
- Quantify and monitor HCPs of interest through every biomanufacturing step