The very forces critical to creating the three-dimensional structure of proteins are also responsible for unwanted and often dangerous protein aggregates in protein-based therapeutics. The presence of such aggregates can mean the discontinuation of potentially critical therapeutic products. The FDA has advised in its 2014 Guidance for Industry that "It is critical for manufacturers of therapeutic protein products to minimize protein aggregation to the extent possible,'' while acknowledging that the technology does not currently exist to accomplish this goal, particularly in the critical range from 500 nm to 10 microns.
Total Holographic Characterization® enables the detection and monitoring of protein aggregation.
Protein aggregation occurs at almost every stage in the biopharmaceutical pipeline, from development, formulation, and manufacturing to storage and point of use. Thus, there is a pressing and as-yet unmet need for instrumentation that can assess the size distribution and morphology of protein aggregates in this size range.
Total Holographic Characterization® has the ability to detect and characterize protein aggregates in pharmaceutical formulations. This transformative technology, originally invented to characterize the properties of spherical colloids and emulsion droplets, can measure single clusters rapidly enough to be used for in-line characterization of pharmaceutical samples, and offers unprecedented and independently verified precision and accuracy to monitor aggregation behavior and to distinguish aggregates from relevant similarly sized contaminants.
Total Holographic Characterization® of protein aggregation will provide the detailed data needed for product development, process control and quality assurance in the biopharmaceutical industry and will result in increased efficiency, safety and cost savings in the promising and rapidly growing area of protein-based therapeutics.
Contact us for more information on how Spheryx can help with your biologic products.