In a previous post, we looked at innovative methods to assess immunogenicity in biotherapeutics and biosimilars.

The objective though, is to have the least immunogenicity possible (exception made for vaccines). Some factors, especially those which are patient-related, cannot be always controlled but some can definitely be monitored during the production processes of biotherapeutics and biosimilars. Let’s take the case of  Host Cell Proteins (HCPs).

Following on from my previous post on biosimilars and biotherapeutics (or biologics), let’s now take a look at some of the specific criteria for this kind of compound, which are not normally required for “classical” drugs. One of them is immunogenicity.

Immunogenicity is the ability of a given product to raise an immune response in an animal or a human. Biological products have this “tendency” to provoke this immune response, so this has to be carefully controlled. For vaccines, we are interested in getting high immunogenicity. For other biotherapies, though, immunogenicity should be as low as possible.