In the past years biopharmaceutical companies have searched for new biological entities (NBE’s) as a follow-up of the very successful monoclonal antibodies. One of the most promising new lines of NBE’s are the Antibody Drug Conjugates. Antibody Drug Conjugates (ADC’s) are new biotherapeutic medicines consisting of a drug (chemotherapeutic agent), a (non-)cleavable linker and a monoclonal antibody. The mechanism of action consists of the recognition of a specific receptor on the cells by monoclonal antibodies, the complete ADC is internalized into the cell and the cytotoxic agent is released in the cell by cleaving the linker and the monoclonal antibody from the ADC so that the cytotoxic agent is able to block cellular processes followed by cell death. Recently the first new ADC variant brentuximab vedotin (Adcetris®) from Seattle Genetics received FDA approval as a new treatment for U.S. patients with a pair of rare lymphomas—Hodgkin’s disease and anaplastic large-cell lymphoma. As second product T-DM1 (Kadcyla®) from Roche received FDA approval as improved treatment for HER2-breast cancer. In this presentation we will show the current progress on the development of purification processes for Antibody Drug Conjugates using duocarmycins as Linker Drug technology with a cleavable linker. Characterization of the ADC’s with physicochemical/biochemical studies and the precautions taken to perform conjugations and purifications of the ADC’s to final drug substance are being discussed.

Antibody drug conjugates: A new platform of protein therapeutic molecules with duocarmycins as cytotoxic agents

249th National Meeting (2015)

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