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DIA LC-MS in our opinion is the best approach for un-targeted ID and Quant of all HCPs in a sample. Ejvind Mørtz, PhD, Co-Founder & COO of Alpha...

For mAbs and some viral products there are native digest methods that partly remove the DS enabling HCP analysis with lower LOD. However, HCPs binding...

Quantitative bias is addressed by verification by alternative quantitation methods, for example quantitative amino acid analysis (AAA). Ejvind Mørtz...

LC-MS-based analysis of HCPs can be used in support of process development to provide insight into the population of HCPs in the product throughout pu...

When LC-MS is used to assess the coverage of a (kit) ELISA, an evaluation is made of the HCPs that are recognized by the polyclonals and the ones that...

LC-MS based coverage analysis of the ELISA antibody as well as characterization of the HCP standard fit to actual HCPs in process, are typically inclu...

In principle, it’s not, assuming an ELISA is (commercially) available to provide insight into the total levels of residual HCPs in the final product. ...

The ELISA should cover the majority of HCPs in the early process sample. There is no formal % coverage accepted as it depends on the coverage method, ...

See USP 1132.1 on best practices. And the publication “Host cell protein quantitation by LC-MS. Experimental demonstration, qualification, and compari...

The company I work for is not running LC-MS-based HCP analysis in a GMP environment, so I don’t have experience with the GMP aspects of data processin...

Yes, Alphalyse has many LC-MS projects in QC. See our webinar with BioQC for further in-depth information and discussions: ‘Moving HCP LC-MS analysis ...

Sometimes. The principles of the 2 methods are different, the calibration standards are different, the HCP coverage is different, and the individual q...

Personally, I have no experience with AAV gene therapy products. Generally speaking, residual HCPs can be monitored using an ELISA-based assay. The la...

Generally speaking, no MS data are required in the IND in the context of residual HCP analysis, assuming that an ELISA is available to evaluate the le...

Although no formal requirement exist to include mass spec data, it is becoming more frequent in regulatory filings. With the USP chapter 1132.1 it is ...