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

NIH RePORTER · NIH · R44 · $45,000 · view on reporter.nih.gov ↗

Abstract

The objective of this TABA 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 prototypes to sales. This objective is motivated by the needs of the growing protein-based biopharmaceutical therapeutics industry (with global market size over $100 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 TABA will address crucial gaps in QATCH’s current expertise and team and will advance commercialization. In this TABA work, QATCH’s sales consultant will assist QATCH for product sales through 1) developing marketing strategy, 2) preparing to execute marketing and sales, 3) executing the strategy and optimize it through feedback.

Key facts

NIH application ID
11093217
Project number
3R44GM151918-01S1
Recipient
QATCH TECHNOLOGIES, LLC
Principal Investigator
Zehra Parlak
Activity code
R44
Funding institute
NIH
Fiscal year
2024
Award amount
$45,000
Award type
3
Project period
2023-09-15 → 2025-09-14