A Case Study of the Development, Technical Transfer, and Scale-Up of a Lyophilized Antibody-Drug Conjugate Formulation

Antibody-drug conjugates (ADCs) were developed to target the delivery of chemotherapeutic agents and greatly reduce the quantity of chemotherapeutic agent delivered to the patient. These two advantages have increased the interest of the medical community in their use and have greatly increased the number of molecules being investigated. The challenges include aggregation and loss of the chemotherapeutic agent due to the processing conditions.This presentation is a case study in the formulation and process development, technical transfer, and scale-up of a lyophilized ADC.