Haiyan Jiang
Janssen BioTherapeutics, USA
Title: Purification and characterization of antibody therapeutics: Challenges and solutions during lead candidate selection
Biography
Biography: Haiyan Jiang
Abstract
Monoclonal antibody therapies continue to be the focus of biopharmaceutical industry. Hundreds of antibodies are in pre-clinical and clinical development. Purification and characterization of the lead molecules is vital during the lead optimization and candidate selection stage. Protein A affinity chromatography and additional polishing steps are used to purify panels of antibody hits against specific target. Throughout the process, biochemical and biophysical assessment for developability and manufacturability are applied to select lead candidate. This talk will review the methods, the challenges, and how the purification and characterization data contributes to lead selection. A case study will be discussed on a small scale purification method scouting for difficult proteins which facilitated the development of the large scale process and shortened development timeline.