Overview
Enabling better Protein Therapeutics – enhancing speed to market & minimizing risk
Protein aggregation is a problem that impacts biopharmaceutical development from candidate selection through to formulation and delivery. Mechanisms of aggregation are not conclusively known but the developability implications are severe. A fragmented analytical understanding of biologics manifests in product safety, efficacy and immunogenicity risks, contributing to biopharma pipeline failures and resulting in significant cost burden.
Protein Dynamic Solutions (PDS) has developed a High-Throughput Developability and Comparability Assessment Platform (HT-DCA) that allows biopharmaceutical companies to understand stability within the protein regions and mechanisms involved in aggregation – allowing re-engineering or improved formulation.
Protein aggregation is assessed in the presence of various excipients under different stressor conditions. Amino acid side chains serve as probes, meaning the analysis can be carried out in a label-free manner, and in solution at any drug concentration, regardless of its stage in the pipeline.
Improved Biologic Comparability Testing
Comprehensive characterization of protein therapeutics is important for evaluating batch-to-batch comparability during process-, site- or manufacturing changes. Equivalence testing of biosimilars with innovator products in real-time under the same stressor conditions provides statistically robust data to establish analytical biosimilarity.
HT-DCA provides a unique and higher-order structure characterization of drug molecules and provides crucial molecular dynamic information for in silico simulations and protein design. The platform can be used by biosimilar manufacturers to demonstrate similarity or by innovator organizations to provide valuable added patent protection.
Market Opportunity
70% of average biologics R&D costs come from analytical characterization and development, process development and formulation. The instruments available for this purpose today provide insufficient information to meet regulatory Chemistry, Manufacturing and Controls (CMC) requirements and make informed decisions on candidate developability.
PDS’ HT-DCA platform technology will provide essential information across the biopharma value chain, critical to the development of the $190 BN biologic's market.
Unique Capabilties
The HT-DCA is a real-time Hyperspectral Imaging Tool that provides multivariate analysis of critical quality attributes (CQA) necessary for biotherapeutics candidate assessment and re-engineering.
The platform utilizes a first-in-class quantum cascade laser microscope to deliver high-throughput and label-free analysis of liquid samples over an array of formulations and concentrations. Analysis is executed at room temperature or under thermal stress from volumes of 1 microliter or less.
Enhanced productivity is assured through a purpose-built user interface with fully automated data acquisition and analysis.