University of Massachusetts Amherst doctoral student in chemistry Khaja Muneeruddin is one of three promising young scientists to recently receive the 2014-15 Global Fellowship Award from the United States Pharmacopeial Convention (USP), dual publishers of the official pharmacopeia and National Formulary (NF), the book of directions for identifying compound medicines.
The award aims to advance research in quality standards that manufacturers must follow in making prescription and over-the-counter medicines and other health care products. This award will also help address specific scientific needs, USP points out. Its chief executive officer, Ronald T. Piervincenzi said, "I am very pleased that USP has a long-standing tradition of assisting future generations of researchers."
Muneeruddin and two other USP award winners will each receive $30,000 to support their research and study in the coming academic year. They will formally receive their awards next month at USP headquarters in Rockville, Md.
With his advisor, professor Igor Kaltashov, Muneeruddin develops new analytical methods using liquid chromatography and gas phase chemistry in mass spectrometry to characterize a group of pharmaceuticals known to be highly heterogeneous, that is, they have either intrinsic or induced variability, which must be fully described before they can be used.
He explains, "I develop assays for drug manufacturers that they can use for the development, and lot-to-lot quality control, of drugs, in this case protein-based samples. I have developed some methods for tracking changes in the assembly of protein structural units, for example the presence of aggregates or changes in structure from dimer to octamer, that pharmaceutical firms can use in future quality control."
"As drug patents begin to expire in the coming years, these methods will be important for creating monographs, that is the specifications which a new biosimilar drug must meet in order to be approved for use."
Muneeruddin adds, "Pharmaceuticals have gotten much, much more complex in recent years as disease targets have become more difficult to treat. To analyze these kinds of drugs we need to develop novel analytical methods that can provide more accurate information. To win this award is a huge honor, and unexpected because I believed that someone more experienced in standards would win. But it says how important it is becoming now to characterize heterogeneity, especially with all the new, very targeted drugs coming along."
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