Accelerated Formulation Development for Antibody-Drug Conjugates (ADCs)

Knowledge gained during development of the first antibody-drug conjugates (ADCs) to enter development has enabled the identification of a base or “platform” formulation for this new class of potential anti-cancer molecules. From this acquired knowledge, a formulation, Formulation A, has been selected which is suitable for use in pre-clinical toxicology studies. With only minor modifications for some ADCs, this platform formulation has also been shown to provide adequate shelf life to support early clinical trials. Additional challenges have resulted in a standardized approach to clinical administration. Utilizing this formulation development strategy, six additional ADCs have initiated human clinical trials within a period of two years.