Novel Analytical Technologies for Biopharmaceutical Products

Novel Analytical Technologies for Biopharmaceutical Products

Novel technologies and methods are enhancing analytical processes in vaccines and biologics space that is critical to the biopharmaceutical industry.    

FREMONT, CA: Researchers at the Institute for Bioscience and Biotechnology Research (IBBR) has secured $1.1 million from the Food and Drug Administration (FDA) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). This funding will be used to advance the development of analytical methods for characterizing complex drugs and vaccines. Antibodies, vaccines, and other top-selling therapeutics are made up of sophisticated biomolecules like proteins and nucleic acids. Biomanufacturing such products involve lengthy and costly production, along with purification, and packaging processes. Not only are the final products complicated, but the complete biomanufacturing process is complex and sensitive, all of which necessitates the use of advanced instrumentation proficient of sophisticated measurements to monitor the process and validate the ultimate product.

Current measurements necessitate contact with the biomanufacturing solution that introduces additional sampling steps and risks of contamination. Ongoing quality control practices also require opening a subset of vials from each batch, making conclusions about complete batches based on those measurements. Yu's lab is pioneering the usage of water proton nuclear magnetic resonance (wNMR) spectroscopy for biomanufacturing applications. With NIIMBL' s support, Yu's group, along with scientists from vaccine teams at Merck & Co. Inc. and Pfizer Inc., is adapting their flow wNMR methods for monitoring the production and stability of vaccine-adjuvant complexes during biomanufacturing. 

IBBR is a joint research enterprise that is financially backed in part by the University of Maryland Strategic Partnership: MPowering the State, an action designed to deliver innovation and impact via collaboration. The Institute remains at the nexus of academic research plus commercial application that brings crucial elements together necessitated to spur transformative discoveries in the field of biotechnology. This field provides innovative solutions to significant scientific and engineering difficulties important to society. IBBR researchers endeavor to advance the areas of disease pathways and biomolecular measurement sciences, biomolecular targets, and biomolecular engineering, including structure-based design of therapeutics and vaccines.

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