Monoclonal antibodies (MAbs) are rapidly growing class of therapeutic molecules in biopharmaceuticals. More than 80 therapeutic antibodies have been approved by the FDA in the last 30 years for different indications ranging from oncology to autoimmune diseases to respiratory diseases and the number is increasing year by year. Most of the current therapeutic antibodies are immunoglobulin G (IgG) with glycosylation constituting around 3% of the total mass of the molecule. Understanding the impact of glycosylation and close monitoring is critical for monoclonal antibodies and fusion proteins development as therapeutic molecule. Different forms of glycan including sialic acid (NANA/NGNA), galactose, mannose and fucose influence safety, efficacy and pharmacodynamics/pharmacokinetic property (PD/PK) of the therapeutic monoclonal antibodies and fusion proteins. This presentation will highlight the influence of different glycan variants on the drug’s behaviour in the body and draw attention to commonly employed analytical techniques to analyse therapeutic molecules and determine and quantify glycan composition, structure and glycosylation site in them.
Dr Harleen Kaur has been in the pharmaceutical industry for almost 8 years and most recently led the analytics and drug product tech transfer projects for two biologics products while working at AstraZeneca, USA. Prior to this, she worked in R&D division of Fujitsu Asia Pte Ltd in Singapore where she worked on aptamer development and played an integral role in identifying and purifying aptamers against different protein targets in collaboration with National University of Singapore, Agency of Science Technology and Research Singapore, and Japanese diagnostic enterprise Sysmex. In her current role, she is leading a team of analytical scientists at Aurobindo Biologics and her responsibilities include the method development, method qualification and method transfer for different biosimilar products. she completed her PhD in chemical and biomolecular engineering department at National University of Singapore.