Host cell proteins (HCPs)

 

Host cell proteins (HCPs) are proteins that are produced by the cells that are used to produce biologics, such as vaccines and monoclonal antibodies.

HCPs can be present in the final product, even after purification, and can potentially have adverse effects on patients.

The amount of HCPs in a biologic product is regulated by the FDA and other regulatory agencies.

There are a number of methods used to control HCP levels in biologic products, including:

Choosing the right cell line for production

Using media and culture conditions that minimize HCP production

Applying purification steps that remove HCPs

The development of new technologies, such as single-cell analysis, is helping to improve the understanding and control of HCPs in biologic products.

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