The FDA 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 the technology needed to accomplish this goal is currently not available, Dr. Laura Philips, founder, president and CEO of Spheryx said.
“Protein aggregation occurs in the biopharmaceutical pipeline, from development, formulation, and manufacturing to storage and point of use,” she told us, noting that Spheryx’s Total Holographic Characterization® can detect and characterize protein aggregates in pharmaceutical formulation and manufacturing.
As Phillips explained, the NIH grant will enable the analytical services and instruments company to adapt its current technology – which is available in a beta version instrument, xSight – to the needs of the biologics industry to detect, count, and characterize sub-visible protein aggregates in protein-based pharmaceuticals.
“Protein aggregates can induce an immunogenic response that can be dangerous and even fatal, which is why the FDA is so concerned about the presence of these aggregates in formulations of biologic drugs, particularly in the range of 500 nm to 10 micrometers,” she added.
The grant will enable modifications to various aspects of the technology to include high-volume sample handling and high-speed flow, among others.
“Biologics companies have emphasized the need for the ability to make measurements of many samples at a time without the need for an attendant to repeatedly load samples and monitor the process,” said Philips.
Additionally, xSight is able to distinguish potentially dangerous protein aggregates from harmless silicone oil droplets found throughout the industry, which has garnered attention from the biologics industry, Philips said.
“We plan to augment this capability by adding the ability to provide more detailed analyses of the 3-dimensional morphology of the particles we detect to enhance our ability to distinguish dangerous particles from harmless ones,” she added.
Spheryx was previously awarded an NSF SBIR grant to develop its Total Holographic Characterization for commercialization in May 2015.