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Graduate School of Engineering, The University of Osaka, Shimadzu Corporation, and U-Medico Inc. have developed a method to identify serotypes of recombinant adeno-associated virus (rAAV)—viral vectors used in gene therapy— with high accuracy using MALDI mass spectrometry. Although enzyme-linked immunosorbent assay (ELISA) has conventionally been used for serotype identification, variability in measurement results has sometimes posed a challenge.

Feasibility studies of this method were conducted using Shimadzu’s MALDI-TOFMS (matrix-assisted laser desorption/ionization time-of-flight mass spectrometer) "MALDI-8020" to analyze rAAVs representing seven serotypes, including variants that are considered difficult to distinguish. The work was supported by the Shimadzu Analytical Innovation Collaborative Research Center (Suita Campus), and a Shimadzu employee (enrolled in a doctoral program) dispatched by the company played a central role in the research. Shimadzu Corporation and U-Medico plan to pursue development of a MALDI-TOFMS system that adopts this method. The research findings were published in the American journal Analytical Chemistry and made available on March 1 (Japan time).

• Notes:
• 1. MALDI (matrix-assisted laser desorption/ionization) is the technique for which Koichi Tanaka, an Executive Research Fellow at our company, was awarded the Nobel Prize in Chemistry. In this method, a laser is applied to a sample mixed with a matrix (a small organic compound that facilitates desorption and ionization), ionizing large molecules such as proteins without destroying them.
• 2. The employee mentioned above was part of the "REACH Project," which dispatches employees to doctoral programs for two to three years to engage in joint research with universities. In some cases, students hired by the company after completing a master's program are dispatched directly into this program.

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