Genedata Bioprocess

Formulation Development

Fragile proteins and other biologically sourced macromolecules need protection to achieve product stability in final formulations. Only the correct formulation can turn a therapeutic protein into a safe, ready-to-use drug product that can be appropriately dosed. New molecule formats and increasing formulation challenges associated with drug substance stabilization, high-concentration or high-volume self-administration, together with injection pain mitigation, make formulation screening approaches and extensive monitoring of the product’s critical quality attributes (CQAs) necessary. The data coming from such systematic studies analyzing formulation under various stress conditions, both in low- and high-throughput, need to be captured, adequately processed, curated, and analyzed for the establishment of stable, easy to handle formulations.

Genedata Bioprocess® improves the efficiency of formulation development by providing a fully-integrated tracking infrastructure for all formulation samples and related formulation parameters. In addition, the system enables standardization and automation of formulation screens, thereby dramatically reducing costs and timelines.

Integrate

Integrates with laboratory and automation equipment and enables processing and structured capturing of in-process control and physico-chemical characterization methods; molecule views and drug substance production information enable tracking of Critical Quality Attributes

Capture

Captures and monitors the molecule’s Critical Quality Attributes; standardizes formulation screening by systematic tracking of formulation procedures, buffers, and ingredients, together with related samples; stress test and stability assessments (developability assessment)

Process

Processes all information for various formulation tests and screens (e.g., pH screening, composition screening, robustness screening), in the context of the preceding production history of each batch in a formulation study (downstream process, upstream process, cell line)

Interpret

Interprets and identifies the best formulation through multi-criteria decision views, identifying the optimal combination and interaction of input variables, such as material attributes and process parameters

Report

Reports all relevant formulation data and results, such as the effect of different formulation conditions (e.g., exposure time, storage time) on CQAs

Enable

Enables standardized, miniaturized and fully automated formulation screens, increasing throughput and quality of formulation testing