Genedata Biologics® enables the systematic assessment of a candidate’s developability risk profile and critical quality attributes (CQA) to decide on the most promising development candidates. Common problems identified include aggregation issues, formulation instability, and reduced pharmacological activity.
Developability & Manufacturability
Genedata Biologics systematically assesses a drug’s developability and manufacturability by evaluating a comprehensive set of molecular attributes. The platform assesses identity through sequence, structure and glycosylation profiling, pharmacology through specificity and potency, and safety (off-target interactions and Fc receptor binding). It also evaluates stability and viscosity (e.g., pH, freeze-thaw, high- and low-temperature stability testing), degradation (e.g., due to extreme pH values, UV, oxidation), and formulation. Integrated tools enable a data-driven and holistic assessment (or characterization) of all drug candidates, reducing the risk of downstream development and manufacturing challenges.
Genedata Biologics will be our central repository for mission-critical data on therapeutic candidates such as bioactivity, developability, and manufacturability, and will enable transparent decision-making on candidates to move forward with.
Bjoern Hock, Ph.D.
Director, Global Head Protein Engineering and Antibody Technologies
Streamlining Antibody Discovery Processes
“Genedata Biologics will be our central repository for mission-critical data on therapeutic candidates such as bioactivity, developability, and manufacturability, and will enable transparent decision-making on candidates to move forward with.”
Managing Developability & Manufacturability Risks
We present a scalable, off-the-self enterprise workflow system that enables systematic developability and manufacturability assessments from the very early stage to the later stages of the biopharma R&D process.