Case Study: AOC GMP Manufacture For A FIH Study

Explore the development and GMP manufacture of an antibody–oligonucleotide conjugate designed for first-in-human clinical evaluation. It highlights the end-to-end workflow, beginning with early process development and progressing through scale-up, analytical characterization, and final GMP production. Central to the approach is the integration of conjugation chemistry, purification techniques such as ion exchange chromatography, and robust in-process controls to ensure product quality and consistency. The study emphasizes the importance of selecting suitable intermediates, including a functional antibody fragment and modified oligonucleotide, as well as optimizing reaction conditions to maximize yield and efficiency. Consideration is also given to manufacturing timelines, material stability, and process scalability from laboratory to larger production volumes. 

Gain insights into how coordinated development, analytical rigor, and flexible manufacturing capabilities enable timely delivery of high-quality material for early clinical studies.