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Production

The Production module increases the efficiency of the entire protein production process, from the initial definition of the proteins to be produced, to the final, fully characterized high-quality samples. The platform tracks and validates individual steps including all protein expression and purification batches, as well as vector and cell line batches. Its built-in inventory management facilitates sample and aliquot tracking in the laboratory. Analytical characterization and QC data, such as LC-MS, SEC, HIC, endotoxin levels, glycosylation profiles, and functional data from in vivo assays, are aggregated and directly linked to their respective samples. Certificates of Analysis (CoA) and other relevant sample reports can be generated automatically using built-in tools. The platform also includes explicit data organization models for multi-vector expression systems, which is of critical importance when working with multi-chain proteins such as antibodies (e.g., IgGs and bispecifics).

Integrate

The system has been designed to support a division-of-labor work environment by integrating data from specialized groups focused on specific tasks covering the full production workflow, including molecular biology, expression, and purification as well as analytics and characterization.

Capture

The system captures all experimental data including host cell lines and expression protocols, process parameters, purification techniques, and product modifications such as conjugations, de-tagging, or buffer optimization.

Process

Out-of-the-box tools for laboratory operations include pooling, splitting, and complexation using both individual samples as well as bulk processing with high-throughput production and automation.

Interpret

The system enables a systematic assessment of a candidate’s developability and manufacturability risk profile by evaluating intrinsic molecular properties that may influence the technical development of the drug candidate.

Report

Single-point and automated generation of reports and Certificates of Analysis (CoAs) bolsters transparent handover of quality-checked samples among different groups in the protein production workflow.

Enable

The integration of all assay, analytics and QC data from different groups and sites allows for a one-click assessment of any sample and molecule in real time.

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