Multi-Attribute Method Implementation
Combining both in-depth characterization and automated critical quality attribute (CQA) monitoring in a single platform, Genedata Expressionist® provides the end-to-end solution for mass spectrometry (MS)-based multi-attribute method (MAM) implementations of a quality-by-design (QbD) framework in biotherapeutic development and production, with built-in compliance for regulated environments.
To use MAM throughout R&D as well as clinical and commercial QC, a harmonized workflow using a single software solution is of great benefit. Therefore, we set out to partner with Genedata to develop targeted attribute monitoring as well as new peak detection workflows.
A Central Knowledge Base.
Enable Quality-by-Design.
The enterprise nature of Genedata Expressionist enables full integration into and across existing data systems to provide a sophisticated and scalable MS data processing platform. It creates a centralized knowledge base, which allows product information generated during a drug’s life cycle to be used throughout organizations.
Experience and Expertise.
End-to-End MAM Implementation.
Genedata Expressionist is the software of choice for MAM implementation, thanks to the experience, domain knowledge, and expertise of our team. As a long-standing member of the MAM consortium, Genedata supports the biopharma community with robust MS-based methods for biotherapeutic research, development, and quality control.
Towards MAM in QC.
Product Purity Assured.
The New Peak Detection (NPD) workflow in Genedata Expressionist was developed in close partnership with Novartis . It enables reliable impurity detection and streamlines quality control by unifying MS across R&D and manufacturing. This breakthrough minimizes false positives and positions Genedata Expressionist as the go-to MS solution for regulated environments.
GMP-Ready. Simplified Validation and Regulatory Submissions.
The comprehensive GxP-ready MAM workflow is designed for both CQA monitoring and robust NPD. Users have successfully validated the workflow in accordance with ICH Q2 guidelines and applied it across development and MAM applications, achieving sensitive and accurate identification of new peaks with zero false positives. This streamlined solution enables efficient implementation of MAM while maintaining compliance and analytical rigor.
Customer Stories
Exploring Emerging Biotherapeutic Modalities
Validating Automated MAM Approaches in Biopharma
