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. https://pharmaceutical.report/Resources/Whitepapers/49f3b47b-98cd-4625-bb6b-b0e187fff415_pharmaceutical_development_adcs_whitepaper.pdf
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PHARMACEUTICAL DEVELOPMENT FOR ADCS: NOT AS SIMPLE AS ABC
Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution and a freeze-dried solid presentation, ultimately choosing the most successful candidate for final development. An antibody-drug conjugate, or ADC, consists of a monoclonal antibody (mAb) joined to a highly potent or cytotoxic drug by a stable, chemical linker with labile bonds. The antibody is targeted to attach to an antigen on the surface of a tumor cell. Once the connection is made between surface antigen and antibody, the antibody and linked drug are incorporated into the tumor cell. The drug is then cleaved from the antibody, and goes to work to destroy the tumor cell. Once internalized, the amount of “payload drug” required to cause cell death is relatively small. For that reason, ADC’s are generally better tolerated by patients than more traditional forms of chemotherapy. DOWNLOAD