Joseph R Cohen, Stephen R Brych, Siddharth Prabhu, Vivian Bi, Ahmed Elbaradei, Joshua M Tokuda, Cathie Xiang, Martha Hokom, Xiaohong Cui, Claudia Ly, Nathan Amos, Jilin Sun, Dominador Calamba, Jonathan Herskovitz, Allyson Capili, Kimya Nourbakhsh, Anthony Merlo, Julia Carreon, Jette Wypych, Linda O Narhi, Vibha Jawa, Marisa K Joubert
BACKGROUND AND PURPOSE: There is concern that subvisible aggregates in biotherapeutic drug products pose a risk to patient safety. We investigated the threshold of biotherapeutic aggregates needed to induce immunogenic responses. METHODS AND RESULTS: Highly aggregated samples were tested in cell-based assays and induced cellular responses in a manner that depended on the number of particles. The threshold of immune activation varied by disease state (cancer, rheumatoid arthritis, allergy), concomitant therapies, and particle number...
March 22, 2024: Pharmaceutical Research