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A robust Approach to cGMP productionFrom the 1960s when monomeric pyrrolobenzodiazepines (PBDs) such as anthramycin were isolated and characterized, to the dramatic increase of potency induced by dimerization in the 2000s, PBD dimers have evolved as one of the leading classes of antibody drug conjugate (ADC) payloads. Currently, 17 ADCs are in clinical trials involving PBD-dimers. Four different PBD-dimer ADC payloads are in clinical trials: Talirine (SGD-1910) from Seattle Genetics; Tesirine (SG3249) from Spirogen, MedImmune, ADC Therapeutics, and Abbvie; and DGN462 and DGN549 from Immunogen. With the most advanced PBD-ADC program, Abbvie- StemCentrx’ Rovalpituzumab-tesirine (Rova-T) closing to commercial launch, this technical report summarizes the production challenges and solutions presented by the PBD-dimer platform. What you will learn : > The Specific Challenges of PBD Synthesis and Purification |