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.