NMR Spectroscopy for Robust Assessment of the Higher Order Structure of Biologics
Biopharmaceuticals are the fastest growing segment of the pharmaceutical industry. Similar to the concept of generic drugs, innovator biologics are also re-produced upon patent cliffs and marketed as “Biosimilars”. Clinical trials play a crucial role for the approval of biosimilars. Therefore, biosimilar drug products must demonstrate structural and functional similarity to the innovator’s molecules in order to ensure both the effectiveness of the drug and the patients’ safety. Traditional higher order structure (HOS) characterisation techniques, though routine, provide information on global picture of a biological product. For ‘biosimilars’ any subtle differences in the protein structure especially in the vicinity of its binding partners could be alarming. Therefore, robust methods are needed for the precise measurement of biopharmaceuticals structure and aggregation states for drug quality assessment and comparability. NMR offers a highly sensitive fingerprinting approach for assessing conformational changes of biomolecules. NMR diffusion data together with Analytical Ultracentrifugation data can provide precise insight into aggregation states of the Biopharmaceutical product. During this talk, Dr. Ashutosh Kumar, Associate Professor from the Department of Biosciences and Bioengineering, IIT Bombay, Mumbai, will cover the importance of high-resolution NMR techniques, which need to be implemented at an early stages of thedrug development to circumvent future manufacturing challenges.