Immunogenicity testing is focused on the detection and characterization of anti-drug antibodies (ADAs) and the determination whether these ADAs are neutralizing antibodies(NABs), as NABs may affect the pharmacokinetics (PK) of the drug. It is clear however that animal studies are not considered relevant to predict immunogenicity in humans. Still, the selection of the mini-pig to explore their possibilities for immunogenicity testing of biopharmaceuticals, especially to assist in the interpretation of safety studies , is based on the improved knowledge that various physiological aspects of Göttingen Minipigs® resemble more the human situation than other animal species. It is expected therefore that in the near future the safety testing, including immunogenicity testing of biopharmaceuticals in mini-pigs will increase as an alternative for non human primate studies, which use will be limited or restricted. Immunogenicity Services Screening as...
Integrated Drug Discovery Services- Chemistry, Biology & Preclinical Services