This volume provides a comprehensive recapitulation of structure-activity relationship (SAR) from a mechanism of action point of view for this unique therapeutic modality, in a largely disease agnostic manner. From a disease biology and pharmacology perspective, the cellular target and drug-conjugate selection, considerations on liker -chemistry and -antibody ratio, and formulation science and technology, to get from bench to bedside (i.e. from a laboratory to the systemic circulation in a patient). The book also provides an understanding around target binding and drug/"payload" release mechanisms. Furthermore, pharmacokinetic and safety pharmacological aspects from a regulatory and clinical perspective are discussed, along with current chemistry, manufacturing, controls guidance and emerging novel delivery devices or technologies.

The key differentiation in Antibody Drug Conjugates is the clinical and development discussion, that offers pragmatic considerations in medical product development, IP, regulatory considerations, among others. Furthermore, we discuss the topic as a platform, in a disease agnostic manner.

Offers a clinical and developmental discussion for pragmatic medical product development Unique presentation from a disease agnostic view Includes novel delivery devices and technologies

Inhalt

Commercialized ADCs: A Market Snapshot for Exemplification.- Application of ADCs to Therapeutic Areas Outside of Oncology.- Regulatory framework for the manufacturing and marketing of ADCs.- Conjugation Chemistry and Chemical Design for the Discovery and Development of Antibody Drug Conjugates.- Clinical Pharmacology Considerations in Antibody-Drug Conjugates Development.- Bioanalytical Methodologies for Pharmacokinetic Characterization of Antibody Drug Conjugates.- Toxicology Considerations on Antibody-Drug Conjugate Discovery and Development.- Considerations for Antibody Drug Conjugate Design Stability and Formulation.