# Injectability analysis of high concentration protein formulations by extending shear-rate range in microfluidic quartz viscometers

> **NIH NIH R43** · QATCH TECHNOLOGIES, LLC · 2020 · $250,000

## Abstract

The objective of this SBIR Phase I proposal is to expand the viscosity measurement range of QATCH’s
innovative nanovisQTM technology for accurate injectability and manufacturability screening of protein-based
therapeutics. This objective is motivated by the needs of the growing protein-based biopharmaceutical
therapeutics industry (with global market size over $80 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 injectability and manufacturability issues,
which cannot be determined at early stages of drug development due to the high sample volume requirements
of conventional rheology techniques. By developing a wide shear rate range, low volume viscometer, protein
molecules can be optimized for injectability/manufacturability and candidates with better developability can be
selected for scaling-up. This proposal is significant because the proposed device can assess injectability of
protein formulations earlier in drug development than existing technology and consequently reduce the time and
cost of R&D spent in developing new, injectable protein-based therapeutics considerably. In preliminary studies,
nanovisQTM, which is a microfluidic capillary viscometer with acoustic sensing, has been shown successful in
measuring viscosity at low and very high shear-rates simultaneously using less than 10 microliters in 2 minutes.
QATCH is proposing to 1) expand the low shear-rate range of nanovisQTM by improving the time-resolution and
the minimum detectable flow length, 2) increase the detectable viscosity range of high shear-rates by developing
a post-processing algorithm, and 3) compare injection forces calculated by nanovisQTM results and injection force
measurements. With the expanded shear-rate and viscosity range, nanovisQTM should be able to identify critical
shear-rates, power-law coefficients, and high and low plateau viscosities of protein-based therapeutics.

## Key facts

- **NIH application ID:** 10080997
- **Project number:** 1R43GM139438-01
- **Recipient organization:** QATCH TECHNOLOGIES, LLC
- **Principal Investigator:** Zehra Parlak
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $250,000
- **Award type:** 1
- **Project period:** 2020-08-01 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080997

## Citation

> US National Institutes of Health, RePORTER application 10080997, Injectability analysis of high concentration protein formulations by extending shear-rate range in microfluidic quartz viscometers (1R43GM139438-01). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10080997. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*