Do you want to analyze your biosimilars for process related impurities / HCPs?
FDA requirements include that for biosimilars, process related impurities “should be identified, characterized as appropriate, quantified, and compared with multiple lots of the proposed product to multiple lots of the reference products“.
For this purpose, we have developed a sensitive HCP analysis for mapping process related impurities. Based on mass spectrometry SWATH technology, the method is ideal for identification and quantification of host cell proteins down to the low ppm concentrations.
What is SWATH? >>
Current status for the Host Cell Protein assay:
- Individual HCP quantification down to 10 ppm
- Identification of single HCP < 1 ppm
- Assay setup 4-6 weeks
- Sample analysis 1-2 weeks
- Applicable for all types of expression systems – CHO, E.coli, HEK cells etc.
- All types of biologics incl. mAb, ADC, vaccines, small/large proteins …
Don’t risk your biosimilar project. Let us help you with an objective comparison of HCP in multiple lots of biosimilar and originator.