Detection of leached Protein A, Protein G, BSA, anti-BSA or FCS and Host-Cell Proteins (HCPs) or anti-HCP… are considered as critical quality attributes (CQA) in industry and they have to be assessed prior to batch release.
The most popular method to acheive a sensitive detection is Immunoassays, started with ELISA (enzyme-linked immunosorbent assay) but other orthogonal methods (such as LC-MS) are appearing to help identifying individual HCPs and better understand their potential impacts. Please check below littérature describing analytical tool for HCP measurment.
Litterature : 1 Wang X, Hunter AK, Mozier NM. Host Cell Proteins in Biologics Development: Identification, Quantitation and Risk Assessment. Biotechnol. Bioeng. 103(3) 2009: 446–458; doi:10.1002/bit.22304. 2 Zhu-Shimoni J, et al. Host Cell Protein Testing By ELISAs and the Use of Orthogonal Methods. Biotechnol. Bioeng. 111(12) 2014: 2367–2379; doi:10.1002/bit.25327. 3 Eaton LC. Host Cell Contaminant Protein Assay Development for Recombinant Biopharmaceuticals. J. Chromatogr. A 705(1) 1995: 105–114. 4 Hogwood CE, Bracewell DG, Smales CM. Measurement and Control of Host Cell Proteins (HCPs) in CHO Cell Bioprocesses. Curr. Opin. Biotechnol. 30, December 2014: 153–160; doi:10.1016/j.copbio.2014.06.017.
You will find hereunder our current list of ELISA kits for bioprocess impurities testing.