Therapeutic protein products can elicit drug specific immune responses in people receiving the protein therapeutic. Antibodies against therapeutic protein products, aka anti-drug antibodies (ADA), are of concern because ADA can impact the safety and efficacy of protein therapeutics by inhibiting the function of endogenous proteins leading to deficiency syndromes, altering the pharmacokinetics and pharmacodynamics of drugs, and causing hypersensitivity responses. Because ADAs pose a risk to patients, ADA risk management programs are essential components of drug development. Immunogenicity risk management is a multifaceted process that includes immunogenicity risk assessment, ADA detection, assessing subjects for signs of harm from ADA, and implementing strategies for mitigating harm from ADA. In this presentation I will highlight immunogenicity risk considerations, discuss assays for anti-drug antibody detection, approaches to understanding the impact of ADA, and ADA risk mitigation.