Protein Dynamic Solutions’ technology allows biopharmaceutical companies to simultaneously evaluate critical quality attributes (CQAs), essential to optimized drug candidate selection, formulation and release testing.
The ProteinMentor™ platform is a quantum cascade laser microscope with enhanced signal-to-noise ratio allowing for fast hyperspectral (HS) image acquisition. Application modules offer simplified workflows for sample analysis and the results can be used to determine:
● Formation of aggregates
● Extent and mechanism of aggregation
● Local and global stability of the protein
● Charge Variants (Asn/Gln deamidation sites)
● Protein Identity
● Binding Interface of Protein-Protein Interactions
● Impact of Formulation on Protein Stability
These evaluations can be performed for both the drug substance and drug product. In addition, ProteinMentor has proven capabilities for the detection of bacteria and endotoxin.
Equivalence testing of biosimilars with innovator products in real-time under the same stressor conditions provides statistically robust data to establish analytical biosimilarity.
PDS provides a unique and higher-order structure characterization of drug molecules and provides crucial molecular dynamic information for in silico simulations and protein design.
ProteinMentor can be used by biosimilar manufacturers to demonstrate similarity and by all manufacturers to evaluate batch-to-batch comparability during process-, site- or manufacturing changes.
For all biotherapeutic testing, the ProteinMentor platform is specifically designed for CQA analysis and is 21 CFR Part 11 compliant, ensuring data integrity. In addition, when used for release testing, the analysis times and product inventory can be significantly reduced. ProteinMentor also offers enhanced protein forensics to gain further insight into aggregation and stability issues for both the drug substance and drug product.