In October, Chetan Goudar, PhD, vice president at Amgen process development, and his colleagues wrote in Current Opinion in Biotechnology: “Rapid technological advances have significantly improved the capability, versatility, and robustness of mass spectrometers which has led to them playing a central role in the development, characterization, and regulatory filings of biopharmaceuticals.” In fact, MS can be used in more areas of bioprocessing than ever.

This technology “was initially limited to protein characterization where no suitable alternate technologies were available,” Goudar says. “With improvements in equipment sensitivity coupled with reduction in size and complexity, applications have expanded exponentially and now include the entire spectrum of bioprocess development and molecule commercialization.”

According to Goudar, “protein characterization efforts have expanded and applications in bioprocess development—clone screening, medium formulation, proteomics, metabolomics, impuriomics, etc.—are seeing increasing use.” The advances in MS technology triggered one of Amgen’s recent MS-based improvements in bioprocessing, which is the “successful application of MS for release and stability testing in a GMP setting,” Goudar says.

Even more uses of MS in bioprocessing lie ahead. As Goudar and his colleagues concluded: “We anticipate rapid technological improvements to continue that will further accelerate widespread deployment of MS, thereby elevating our overall understanding of product quality and enabling attribute-focused product development.”

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