Translating Innovation to Clinic: End-to-End Bioprocess Development and cGMP Manufacturing of N332-GT5 HIV Vaccine Candidate for First-in-Human Trials HVTN144
Sam Pallerla, Shaunak D. Uplekar, Ferenc L. Boldog, James C. Paulson, Sabyasachi Baboo, John R. Yates, Wen-Hsin Lee, Gabriel Ozorowski, Joel D. Allen, Max Crispin, Christopher A. Cottrell, Andrew B. Ward, Varsha Sitaraman, Tim Broderick, Amber Costakes, , William R. Schief
This paper describes the development and cGMP manufacturing of an HIV vaccine candidate for clinical trials, demonstrating scalable production and quality control.
bioRxiv · Jun 16, 2026 · PreprintBioengineering