Cleaning Considerations for Antibody Drug Conjugate (ADC) Products: Poster Presented at PDA Week 2026.

Abstract

Novel drug products such as antibody drug conjugates (ADC) can present unique cleaning challenges based on the toxicity of the drug and degradation profile of the drug product. Equipment cleaning concerns are often overlooked during design, startup, and commissioning of biopharmaceutical facilities. Failures to understand cleaning agent selection, critical cleaning parameters, drug product degradation, analytical method recovery factors, and stainless-steel maintenance can lead to costly delays in the process. The cleaning validation strategy of ADC products can also encompass direct, indirect, and non-direct product contact surfaces.The roundtable discussion will be divided into four areas of focus: cleaning validation considerations for monoclonal antibody, attachment-linker assembly, highly potent drug, and antibody drug conjugate. The roundtable will engage the audience with a short description of the four areas of cleaning consideration followed by audience questions and possibly debate.