The Innovation & Quality Consortium (IQ) Translational and ADME Sciences Leadership Group (TALG) working group for the ADME of therapeutic proteins evaluates the current practices, recent advances, and challenges in characterizing the PK and biodistribution of therapeutic proteins during drug development, and proposes recommendations to address these issues. Incorporating the in vitro, in vivo and in silico approaches discussed herein may provide a pragmatic framework to increase early understanding of PK/PD relationships, and aid translational modelling for first-in-human dose predictions.