What provokes an antibody response in patients upon exposure to a biopharmaceutical?
An immune response to a biopharmaceutical protein can be provoked by many different factors, regardless of whether the product is derived from human or animal plasma or is a recombinant protein.23,27 For example, the body can recognize a single difference between the amino acid sequence of the host protein and the human or nonhuman biopharmaceutical protein.23,24 This single difference can be sufficient to provoke an immune response and the generation of antibodies. Immunologic reactions to some biopharmaceuticals may be provoked by minor impurities or protein aggregates present in therapeutic biological preparations.23 ( In most cases, the more immunogenic the minor impurities present in the biopharmaceutical, the more robust the antibody response.