Biologics are a group of medicinal products that are playing increasingly important roles in combating life-threatening diseases where there are no current treatments. Biological products include vaccines, cells and tissues, gene therapies, and recombinant proteins. In contrast to most conventional drugs which have a precise chemical structure and the chemical synthesis is well-defined, most biologics are complex mixtures that are not easily identified or characterized and where production requires cutting-edge technology.
This presentation will focus on the most active industrial product development activities of Biologics: monoclonal antibody-based therapeutics. Dr. Fubao Wang will describe the processes for how to manufacture, characterize, release monoclonal antibody products and how to gain health authority’s approval for the use in patients, and the challenges during development and the strategies to overcome issues such as yield, purity and stability. The goal is to develop safe and effective therapeutics to treat complex diseases such as immunological disorders and cancer.