This STTR Phase I projects aims to address major limitations in the analysis of pharmaceuticals that are based on proteins, a group of therapeutics known as biologics. Current methods for sample preparation and analysis of these drugs require highly trained staff and expensive equipment to execute the multitude of different analytical approaches that are employed to characterize these molecules. Both personnel and equipment costs combine to limit the number of drug candidates evaluated by pharma companies, makes it more difficult for regulatory agencies to reproduce data provided in applications and makes it difficult to identify counterfeit drugs. The company aims to address this issue by creating a highly flexible sample preparation device based on a fluidic channel that operates at reduced pressure. Proteins trapped within the channel can undergo digestion, reduction, alkylation and other common sample preparation procedures in an unattended and automated fashion. Subsequently, prepared samples may be eluted at high concentration, ready for downstream analysis. By dramatically reducing the equipment costs and reducing the required expertise for sample preparation, the company?s technology will have a large impact on the number of drug candidates that are evaluated by pharma companies, it will make it easier for regulatory agencies to reproduce data provided by manufacturers, and it will improve their ability to detect counterfeit drugs. All of these benefits will result in more and cheaper biologics making it to the market, ultimately improving the health and wellness of the populace.
The company?s device combines concepts of diafiltration, asymmetric flow field flow fractionation and filter assisted sample preparation to create an automated sample preparation platform that avoids the use of robotics. By avoiding robotics and high pressure, the platform can operate with increased robustness and dramatically reduced cost. The proposed research aims to demonstrate the ability of the device to perform common sample preparation steps, such as reduction/denaturation, digestion, and deglycosylation and assess issues of reproducibility, reliability and carryover. While many of the workflows described herein have been demonstrated in molecular weight cutoff filters, implementation of these within a fluidic channel will directly advance the company?s understanding of the mechanisms of loss in sample preparation, provide a refined estimate of the cost savings that might be achieved in real world applications, and improve our understanding of transport for small molecules across these membranes.
