Formulation and Quality
2019 PharmSci 360
Drug product development for highly potent APIs (HPAPIs) can be quite challenging across drug substance, particle engineering and drug product perspectives. Complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. Crossing the boundary from small molecule to biologics into antibody drug conjugates (ADC) adds additional levels of complexity, especially when combined with accelerated development timeline requirements.
In this presentation, we will present best practices, infrastructure requirements and demonstrative case studies for effective development and manufacturing of HPAPI and conjugation with monoclonal antibodies.