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Biotechnology-derived therapeutics including monoclonal antibodies, proteins, and peptides hold great promise for treating various diseases such as cancer and inflammatory diseases. They also represent an important class of therapeutic interventions. However, because of their large size, complex structure, and complicated manufacture process, biopharmaceutical products can lead to immunogenic responses, resulting in formation of anti-drug antibodies (ADAs). Immune responses to non-vaccine biologics have the potential to negatively affect both patient safety and product efficacy. For example, a neutralizing antibody is deleterious if it inhibits the efficacy of the product, and can be harmful when it cross-reacts with an endogenous counterpart of the therapeutic in patients. Non-neutralizing antibodies may affect the pharmacokinetic properties of the drug, thus may affect dosing regime. These immunologically-based consequences may cause drug developers to either terminate development or limit the use of otherwise effective therapies. Therefore, immunogenicity assessment is a key component of biopharmaceutical safety and efficacy evaluation, and a prerequsite for the successful development of biopharmaceuticals. Furthermore, immunogenicity is also a complex phenomenon, owing to myriad factors potentially affecting immunogenicity.
For the purposes of this book, these factors are grouped into two categories: product-specific factors such as product origin, glycosylation, aggregation, impurities and formulation, and patient-related characteristics such as genetic makeup and immune status and competency. These numerous and varied factors impose challenges to immunogenicity risk assessment and development of risk mitigation strategies. The intrinsic complexity of detection, quantification, characterization, and control or mitigation of ADA argues for advanced statistical methods in both study design and analysis. This book is intended to provide a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity.
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