# High-throughput injectability screening of high concentration protein formulations by microfluidic quartz resonators

> **NIH NIH R44** · QATCH TECHNOLOGIES, LLC · 2024 · $886,907

## Abstract

The objective of this SBIR Direct Phase II proposal is to carry QATCH’s nanovisQ™ technology, which is a
wide-shear-rate range and low volume viscometer for determining developability and injectability of
biopharmaceutical formulations, from single-test sensors to high-throughput and automated format. This
objective is motivated by the needs of the growing protein-based biopharmaceutical therapeutics industry (with
global market size over $300 billion). Protein-based therapeutics are administered as high concentration
formulations due to the volume constraints of subcutaneous injections. However, increased protein-protein
interactions at these high concentrations can cause high viscosity and prevent injectability and manufacturability.
Existing viscometers consume high volumes of sample, which prevents early-stage assessment and still have
high protein and time costs at later stages. By developing a high-throughput, automated, wide shear rate range,
low volume viscometer, protein molecules and formulations can be optimized for injectability/manufacturability
earlier with less cost and risk. This proposal is significant because the proposed device can start assessing
injectability of protein formulations earlier in drug development, perform this test in a higher number of
formulations faster and with less material than existing technologies and consequently reduce the time and cost
of R&D spent in developing new, injectable protein-based therapeutics considerably. As preliminary studies,
QATCH demonstrated wide-shear-rate and low sample volume viscometers for protein formulations in single-
test format. In addition, QATCH showed that 4 simultaneous measurements from 4 sensors with 9 mm spacing
on the same quartz blank can be achieved accurately. As a result, the nanovisQ™ is now positioned to be a 6x4
sensor matrix and automated viscometer for high concentration protein formulations. In SBIR Phase II QATCH
is proposing to 1) develop 4-sensor arrays with extended shear-rate viscosity measurements to serve high-
concentration protein formulations 2) develop 6x4 sensor matrix for the high-throughput system with
environmental control and the automated sample delivery capability. Developing a high-throughput and
automated low-sample volume viscometer is a key step towards commercialization since low-sample volume
and high-throughput are two most important parameters for drug development groups.

## Key facts

- **NIH application ID:** 10916434
- **Project number:** 5R44GM151918-02
- **Recipient organization:** QATCH TECHNOLOGIES, LLC
- **Principal Investigator:** Zehra Parlak
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $886,907
- **Award type:** 5
- **Project period:** 2023-09-15 → 2026-09-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10916434

## Citation

> US National Institutes of Health, RePORTER application 10916434, High-throughput injectability screening of high concentration protein formulations by microfluidic quartz resonators (5R44GM151918-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10916434. Licensed CC0.

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