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Product Quality

A scalable enterprise solution enabling automated, knowledge-driven quality attribute monitoring that leverages insights gained throughout a molecule’s lifecycle. Built-in functionalities for data security, integrity, and traceability facilitate deployment in regulated environments.

Automate routine analysis. Safeguard product quality. Be GxP-ready.

Ensuring Data Quality. From the Get-Go.

The monitoring capabilities of Genedata Expressionist® extend beyond overseeing product quality. The platform‘s open and flexible nature enables automated, process-specific system suitability tests (SSTs), which are performed before data is analyzed to ensure instrumentation is performing properly. Monitoring deviations in instrument performance in this way minimizes process downtime and ensures the quality of acquired data and results.

Automatic generation and distribution of custom-built reports ensures that stakeholders quickly receive the information they need in a form that helps them make fast and informed decisions.

Reproducible. Robust Operation.

As a fully automated platform, Genedata Expressionist is ideally suited to data processing, analysis, and reporting in QC monitoring of biopharmaceuticals. Script-driven processing of raw data files delivers near-real-time MS-based monitoring and enables efficient 24/7 operation.

Learn how an automated Genedata Expressionist workflow enabled targeted, site-specific glycosylation monitoring of biopharmaceuticals at Merck Group.

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Enabling Solutions for GxP.

Built-in compliance functionalities of Genedata Expressionist—such as secure client-server communication, role-based access to projects and data, full audit trails, and locked-down workflows—can be leveraged together with custom processing solutions for GxP implementations in regulated environments.

Discover how Genedata Expressionist automation and compliance features supported Bayer in implementing mass-spec analytics in a regulated environment.

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Customer Stories

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Automating Therapeutic Oligonucleotide QC

"Genedata developed the end-to-end oligonucleotide QC data workflow and provided the consulting expertise throughout the entire project including the validation stage to help us achieve our goals on time and within budget."

Merck Logo

Monitoring Glycosylation of Biopharmaceuticals

"Fully accessible to non-MS experts once implemented, this automated glycopeptide mapping workflow allows confident,  faster, and more accessible data analysis."

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