Using Advanced Mass Spectrometry For Characterization And Quantitation Of APIs And Impurities In Complex Biotherapeutics

The rapid rise in both the number of vaccines and biotherapeutics being developed, as well as their overall sophistication and complexity, has expanded the role of Contract Development and Manufacturing Organizations (CDMOs) in supporting the development of these biologics, including analytical support from product development through to manufacturing. Impurities, which need to be identified, characterized, and assessed, are an inevitable part of developing these complex biotherapeutics.

Impurities are commonly found in the biomanufacturing process, and can negatively impact the quality, safety, and efficacy of the final product. Impurities can be process-related, like host cell DNA and proteins, or product-related, like degradants, precursors, and aggregates. Identifying, monitoring, and controlling impurities through advanced analytics, such as mass spectrometry, is a critical step in ensuring biotherapeutic product quality and safety.

High-resolution mass spectrometry is a powerful tool for analyzing complex samples and is an essential means of characterizing biotherapeutics ahead of regulatory submissions and development milestones. New analytical technologies are constantly enabling biotherapeutic developers to dig deeper and further characterize impurities. It is essential to stay abreast of these innovations to better align your services with evolving regulatory requirements, mitigate safety risks, and ensure product quality. Learn more about the growing role of CDMOs in supporting the development of complex biotherapeutic products and how to optimize the analyte life cycle.