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BioGenes Is Your Partner for Routine and Sophisticated Projects

Read our latest article on reliable HCP monitoring during biomanufacturing

The determination of host-cell-related impurities is one of the major concerns during biopharmaceutical drug manufacturing. To ensure high-level patient safety during clinical trials and upon drug product release, a multitude of regulations have been authored by different regulatory bodies, such as the US FDA and the EMA.

In our latest article, published in the Pharma Focus Asia magazine, we discuss the implementation of regulatory recommendations into the process of reliable Host Cell Protein (HCP) detection and how to address critical steps along the way of an HCP ELISA setup.

Follow the link to reading the article:
www.pharmafocusasia.com/strategy/challenges-and-solutions-hcp-elisa-development