The two groups of applications we are working on implement a novel separation principle based on our shape-memory materials. The groups correspond to the two classes of smart materials we are developing. The lower selectivity, easier to manufacture material is primarily intended for large scale preparative applications. The precise material is intended for small scale analytical applications.
The large-scale application we are developing is a novel Biologics Extractor for Continuous Manufacturing (BECM). Biologics, such as monoclonal antibodies, have become a cornerstone of the healthcare revolution. The main strategy to make biologics more affordable and accessible for patients is replacement of currently dominant fed batch technology with continuous processing. In addition to reducing production costs, continuous manufacturing improves the quality of drugs, requires smaller facilities, is more amenable to scaling and automation, is better adaptable to innovative biologics, and helps to return offshored plants back to the US (e.g., see Publication).
The critical element of continuous manufacturing is the perfusion process to extract biologics from an operating bioreactor. BECM is an advanced perfusion system that addresses multiple challenges of current industrial perfusion processes enabling a new separation paradigm. BECM is expected to operate efficiently in highly concentrated cell-containing suspensions, even inside the bioreactor. Of the currently used perfusion technologies, none is completely satisfactory. BECM will provide a simpler, cheaper, and more eco-friendly solution that can catalyze the acceptance of continuous manufacturing. BECM is easier to manufacture, does not damage cells, exhibits no fouling, and cannot cause loss of product even if damaged. In preliminary experiments, the material used in this application efficiently separated IgG (immunoglobulin G) and virus-size particles from mammalian cell-size particles.
We plan to extend this disruptive technology to other areas where separation of nanosized objects is required from a suspension heavily loaded with large size particles. On the macroscale, those can be separators and concentrators for various steps of biologics preparation. On the microscale, our separators are perfect for the first-stage treatment of analytes such as blood (e.g., to extract cell-free DNA for cancer diagnostics) or sewage (e.g., to monitor for the presence of pathogens).
The second group of applications is for precise separation that implements the smart material with a sharp separation curve. These applications will be designed primarily as microfluidic or lab-on-chip (LOC) systems either standalone or as sample preparation parts of analytical systems. The material will be used for separating biological analytes such as biomolecules, exosomes, viruses, or mycoplasma from complex mixtures, replacing many expensive laboratory devices such as chromatographic systems or ultracentrifuges. These applications are intended for R&D and quality control laboratories in academia and industry as well as for diagnostics systems in healthcare.
Further down the road, we will advance the smart materials to serve as different LOC components such as valves, pumps, injectors, etc.
