Biotech & Pharma

One Standard, Multiple Platforms: ICH Q2(R2) Qualification of Host Cell Protein Analysis by LC-MS/MS

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USP and Alphalyse have qualified beta-lactoglobulin (LACB) as a cross-platform standard for LC-MS/MS analysis of Host Cell Proteins (HCPs), addressing inconsistencies in HCP quantitation across different labs. This development ensures more consistent and reliable results, crucial for regulatory compliance and quality control in biopharmaceutical production.

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