Purity determination is an important detection index for recombinant protein drugs, which directly correlates to the performance of antibody purification processes and product quality. Antibody purity determination consists of two main aspects. First, the effective separation of antibody molecules from process-related impurities. In practice, there are many product-related impurities, such as truncated or extended forms, modified forms, dimers and multimers. These product-related impurities are often relatively close to the target species, so that selection of a suitable separation method may be difficult. The second is the detection and quantification of main protein and product-impurities. Due to the limitations of the sensitivity of various detectors, it can be a challenge to detect trace impurities introduced by some production purification processes.

Date: Wednesday, 30 December 2020, 19:30—20:15

Speaker: Mr Jason YANG

Speech abstract: Purity is a key quality attribute of antibody drugs. Accordingly, purity analysis in process development and quality control has important significance. This live online sharing focusses on the requirements of analytical methods for monoclonal antibody product purity and purity-related tests combined with relevant case-studies to illustrate the importance of purity analysis in process development.

Brief speaker bio

In-depth research and rich practical experience from many years working in the development and characterization of antibody drugs, evaluation of key quality properties of biological drugs, product comparability research, and development of physical and chemical analytical methods. Mr. Yang contributed to the development of more than 9 monoclonal antibody and ADC products, 6 of which are in clinical research. Mr Yang joined the Bioworkshops in 2019 and leads the Analytical Development team.