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Multi-Attribute Method Approaches

Identify & monitor CQAs. Build your knowledge base. Embrace Quality-by-Design. | Genedata Expressionist

Corporate Knowledge Base Enabling Biopharmaceutical 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.

Just Biotherapeutics Case Study

Advanced, Signal-Driven, New-Peak Detection

Using Genedata Expressionist, new peaks are automatically identified and quantitated using dynamic peak detection and clustering algorithms. In contrast to approaches that rely solely on predefined peak lists, Genedata Expressionist takes all available MS data into account during MAM new-peak detection, significantly increasing the likelihood that unexpected contaminants and product variants are detected.

Easy Collaboration. Better Decision-Making.

As an enterprise platform, Genedata Expressionist facilitates knowledge transfer and harmonizes processes within and between labs. Every user has fast and easy access to all relevant knowledge on a given molecule, allowing full leveraging of content-rich MS data in decision-making.

Streamlined Processes. Automated Workflows. Increased Confidence.

Using optimized Genedata Expressionist workflows, data processing for MAM monitoring is fully automated to process hundreds of samples per week with little or no manual interaction. Eliminating error-prone manual steps significantly streamlines MAM monitoring and greatly increases productivity and confidence in data quality.

Experience and Expertise for MAM Implementations

Genedata is a long-standing member of the MAM consortium, whose goal is to enable the biopharma community to implement a robust MS-based method for biotherapeutic characterization and release of biotherapeutics from QC. The experience, domain knowledge, and expertise gained as a member of this consortium are integral to Genedata Expressionist, making it the software of choice for MAM implementations.

Identify & Monitor CQAs. Build Your Knowledge Base.
Embrace Quality-by-Design.

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