Cambridge Healthtech Institute Inaugural CMC Strategies for Antibody-Drug Conjugates

Antibody-Drug Conjugates are, as experts put it, “conceptually very simple, but in practice, extremely complicated.” The complexity of the ADC, which combines an antibody and a drug via a linker, means that it requires triple the amount of control and characterization to achieve the right formulation, stability and consistency for effective scale up and manufacturing that meets the regulatory requirements.

As more and more ADCs come down the pipeline, it becomes imperative for companies to consider the manufacturability of the ADCs, and to incorporate process design and CMC strategies early on in the development stage.

CHI’s CMC Strategies for Antibody-Drug Conjugates conference offers a platform for scientists and engineers to come together to outline the challenges, share creative strategies, methods and solutions for the safe and efficient manufacture of these highly potent and complex molecules.