Award Abstract # 2025974
SBIR Phase I: High-throughput injectability screening of high concentration protein formulations by multiplexed microfluidic quartz resonators

NSF Org: TI
Translational Impacts
Recipient: QATCH TECHNOLOGIES LLC
Initial Amendment Date: August 26, 2020
Latest Amendment Date: October 13, 2020
Award Number: 2025974
Award Instrument: Standard Grant
Program Manager: Erik Pierstorff
epiersto@nsf.gov
 (703)292-0000
TI
 Translational Impacts
TIP
 Directorate for Technology, Innovation, and Partnerships
Start Date: September 1, 2020
End Date: August 31, 2021 (Estimated)
Total Intended Award Amount: $255,748.00
Total Awarded Amount to Date: $255,748.00
Funds Obligated to Date: FY 2020 = $255,748.00
History of Investigator:
  • Zehra Parlak (Principal Investigator)
    zehra.parlak@gmail.com
Recipient Sponsored Research Office: Qatch Technologies LLC
551 DAIRY GLEN RD
CHAPEL HILL
NC  US  27516-4386
(678)908-3112
Sponsor Congressional District: 04
Primary Place of Performance: Duke University c/o Office of Research Support
2200 W. Main St Ste#710
Durham
NC  US  27705-4677
Primary Place of Performance
Congressional District:
04
Unique Entity Identifier (UEI): D5FFZ7RBVYH7
Parent UEI: D5FFZ7RBVYH7
NSF Program(s): SBIR Phase I
Primary Program Source: 01002021DB NSF RESEARCH & RELATED ACTIVIT
Program Reference Code(s): 008E, 8038
Program Element Code(s): 537100
Award Agency Code: 4900
Fund Agency Code: 4900
Assistance Listing Number(s): 47.084

ABSTRACT

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project advances a new type of drug delivery. Protein-based drugs (biologics) have become more popular due to their high specificity of activity and generally low level of side effects. Biologics treat many conditions, impact lives of millions of patients, and have a global revenue of over $100 B. Patients prefer and comply with injectable versions of biologics because injections are rapid and make home-administration possible, unlike IV infusions that require clinic visits lasting several hours. However, the development and utility of many biologics is hampered by their inability to be used via injections because they are thick liquids. The technology developed in this project will act as an early-stage screening to determined the suitability of potential drug formulation for injection, enabling delivery of new drugs.

This SBIR Phase I project will increase the number of injectable protein-based therapeutics by providing early screening of protein formulation viscosity. Viscosity measurements early in formulation development are currently not possible because the existing viscometers require high material volumes. Therefore, injectability of new protein-based formulations cannot be tested until significant amounts of material are developed, typically at late stages of preclinical research. This project will create a high-throughput viscometer that requires only drops for each test, for formulation optimization; it will determine the feasibility of multiplexing microfluidic quartz sensors on the same substrate to achieve simultaneous viscosity measurements. Specifically, in this project, 1) the electronics for the multiplexed sensors will be developed, 2) the multiplexed sensors will be designed using analytical and finite element models, and 3) these designs will be executed by microfabrication. Finally, the multiplexed microfluidic quartz sensors will be tested by analyzing relevant formulations simultaneously.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

PROJECT OUTCOMES REPORT

Disclaimer

This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.

This SBIR Phase I project had proposed to determine the feasibility of parallel viscosity testing using multiplexed microfluidic quartz resonator sensors on the same quartz blank. The feasibility of parallel viscosity testing of multiple fluids on one quartz blank was the first step toward achieving high-throughput viscosity measurements by these sensors. The high-throughput viscosity testing capability is especially important while optimizing protein-based therapeutics formulations during drug discovery, as the manufacturability and injectability of the formulations depend on viscosity response to a wide range of shear-rates. A truly high-throughput system is rapid and consumes low sample volumes, which are both possible by QATCH?s microfluidic quartz sensor technology, also known as the nanovisQ?.

The core technology behind this research is the innovation of combining quartz acoustic sensors with microfluidics. The technology underlying quartz resonators is well established, simple and robust, and amenable to provide compact instrumentation. Integrating microfluidics to the quartz sensors brings the benefits of extremely low liquid volume requirements, control over how liquid is observed by the sensor, and high position and time resolution measurement capability of fluids motion inside the microfluidics. The research in Phase I project demonstrated that multiplexed microfluidic quartz sensors can measure viscosity of 4 samples at a wide range of shear-rates by using only 5 microliters of each sample in less than 5 minutes of total experimental time. Significant research outcomes of this research included, 1) electrode spacing and design to prevent crosstalk between sensors, 2) instrument development to achieve parallel viscosity measurement, 3) testing of Newtonian and non-Newtonian solutions.

At the end of this SBIR Phase I project, we determined that multiplexed microfluidic quartz sensors can measure viscosity of 4 solutions in parallel in 5 minutes by consuming only 5 microliters of each solution. The viscosity measurement was observed at a wide range of shear-rates and can be used to determine injectability and manufacturability of formulations. By building on this outcome, QATCH determined that 24-well microfluidic quartz sensors can be constructed towards high-throughput manufacturability and injectability testing.


Last Modified: 09/02/2021
Modified by: Zehra Parlak

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