2023 FDA Science Forum
Evaluating Traditional Mass Spectrometry Against the New Generation of Emerging Analytical Technology
- Authors:
- Center:
-
Contributing OfficeCenter for Drug Evaluation and Research
Abstract
Analytical instrumentation is essential to evaluate product quality and for the development of process controls in biopharmaceutical drug product manufacturing. Liquid chromatography mass spectrometry (LC-MS) is used in a wide range of various applications across the manufacturing platform from methods related to drug product quality, such as glycans in monoclonal antibodies, to the process development of cell culture to monitor amino acid and metabolite concentrations in a cell culture feed. Due to LC-MS capacity to address complex questions with flexible application, LC-MS instrumentation requires a user with a high level of technical experience for experimental development and is generally more time-consuming than other analytical methods. Recently, new analytical equipment such as 908 Devices’ REBEL attempts to address the complexity of LC-MS by creating an instrument with simple procedures while retaining the traditional LC-MS ability to specifically identify and quantitate amino acids and several other important metabolites. REBEL allows for comprehensive analysis and high throughput sample testing with the advantage of minimal method development and sample preparation. There is a growing interest to implement these simplified user-friendly approaches instead of the labor-intensive traditional LC-MS methods. Our study aims to compare this new generation of LC-MS analytical platform, 908 Devices’ REBEL, against traditional LC-MS methods and evaluate the quality of data with respect to the trade-offs in operation and resourcefulness between these analytical instrument types.
