By Gareth Macdonald

New mass spectrometry (MS) methods are changing how drug firms monitor quality. And, according to the author of a new study, collaboration between suppliers, software developers, and regulators will see use of the technique expand even further.

The study, published in the current edition of the Journal of Pharmaceutical and Biomedical Analysis, looked at industry use of MS and identified some major changes says author Xuanwen Li, PhD, principal scientist, analytical R&D at Merck & Co.

“We have seen increased use of MS in manufacturing moving from product and process characterization to GMP/QC release. As mentioned in the paper, the increased use of MS aligns with the quality by design (QbD) framework and realization. With older HPLC and CE based assays, the product quality is determined by the chosen method and not by the specific product quality attribute.

“Compared to traditional assays, MS-based methods have demonstrated the ability to overcome some of the limitations of traditional assays by enabling the quantification of multiple amino acid site-specific product quality attributes with high specificity and sensitivity.”

In the paper, Li cites root cause analysis as an area where quantitative MS is making a difference, explaining that when data from conventional quality characterization assays fall beyond specified limits, MS assays are increasingly used to find out exactly why.

Expansion

And Li expects biopharma use of MS in quality control and monitoring will increase as industry and technology developers work together to advance systems.

“Collaboration between the biopharma industry and instrument and software firms can drive advancements in mass spectrometry technology, customization for biopharma applications, regulatory compliance, training and support, and the development of application-specific solutions and standard workflow.

“These collaborative efforts can significantly increase the use of mass spectrometry in biopharma, enabling more efficient and accurate analysis of complex biomolecules and supporting drug discovery, development, and quality control processes,” he says.

Li also says regulatory support for advanced techniques will increase use of MS in QC, citing the U.S. FDA’s Emerging Technology Program (ETP)—which sees agency staff work with industry on the “development and implementation of a novel technology” as an example.

“Those innovations will lead to improved process efficiency and enhanced product quality, and potentially results in reduced production costs for broader global availability of innovative medicines.”

Training

For companies looking to switch to MS-based quality control planning is key. Making best use of these versatile yet complex systems will require companies to set up a robust and flexible data infrastructure and establish staff training programmes Li says.

“The investment in high-quality and user friendly mass spectrometry instruments and software and data storage that are suitable for the manufacturing needs are key to make the best use of MS in manufacturing. Instrument redundancy and cost are also important for implementing this new technology in manufacturing.”

“Proper training of personnel is crucial to utilize mass spectrometry effectively in manufacturing. Biopharmaceutical companies should invest in training programs for their scientists and technicians to ensure they have a solid understanding of mass spectrometry principles, instrument operation, data analysis techniques, and interpretation of results. Training should also cover good manufacturing practices, safety protocols, and compliance with regulatory requirements.”

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