Considerations for Implementation of Multi-Attribute Methods for Biotherapeutics

Description:
Considerations for Implementation of Multi-Attribute Methods for Biotherapeutics

Annu Uppal, PhD, Associate Director, Scientific Affairs & Strategy, US Pharmacopeia  

Multi-attribute Methods (MAM) for analytical testing of biotherapeutics are gaining traction due to their potential to improve efficiency and provide more detailed information on quality attributes as compared to conventional methods. The most common form of MAM analysis digests the protein therapeutics into peptides which are then analyzed by mass spectrometry, enabling the assessment of multiple product quality attributes (PQAs) in a single assay. While this approach has been used routinely in product development and characterization, many organizations are now extending its use to the QC environment. However, MAM analysis can be highly variable across laboratories due, in part, to differences in sample preparation, instrumentation, data analysis and software. In addition, USP established MAM Exchange, an online platform to facilitate MAM adoption by sharing knowledge, discussions and learning through peers. This presentation will discuss considerations that can impact the quality and consistency of MAM and approaches to enhance the robustness of this emerging technique.

Speaker: Annu Uppal - USP