Biopharmaceuticals are protein based products made in either prokaryotic or eukaryotic cells. The term “biologics” is often used to cover a wide variety of product classes from vaccines, protein replacement products (such as insulin, erythropoietin and blood clotting factors to name a few), gene therapies, or gene silencing products such as siRNAs and oligos (actually non-proteinacious products and may be chemically synthesised) and of course monoclonal antibodies (mAbs).
For vaccines, immunogenicity is an intended component of the pharmacology. This brief review will focus, not on intended or expected immunogenicity (as is seen with vaccine products) but rather unintended immunogenicity that can occur with other classes of biological products.
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