# Instrument for Holographic Characterization of Protein Aggregates

> **NIH NIH R44** · SPHERYX, INC. · 2020 · $1,003,165

## Abstract

Project(Summary(
!
The very forces critical to creating the three-dimensional structure of proteins are
also responsible for unwanted and often dangerous protein aggregates in
protein-based therapeutics. Protein aggregation occurs at every stage in the
pipeline, from development, formulation, and manufacturing to shipping, storage
and point of use. The FDA advised in its 2014 Guidance for Industry that “It is
critical for manufacturers of therapeutic protein products to minimize protein
aggregation to the extent possible'', while acknowledging that technology does
not currently exist to accomplish this goal, particularly in the critical sub-visible
range from 100 nm to 10 microns. Thus, there is a pressing and unmet need for
instrumentation that can assess the size distribution and morphology of protein
aggregates in this size range. The parent SBIR Phase II program is meeting this
need by developing an instrument based on holographic video microscopy
(HVM) to detect and count protein aggregates rapidly and reliably enough for
monitoring pharmaceutical formulations. Results from the Phase II work has
resulted in sales of instruments to major pharmaceutical companies and
universities. Early adopters and prospective customers have identified key
additional capabilities that would enable them to deploy this technique at all
stages of their process from formulation development and metrology into quality
assessment and manufacturing process control where Spheryx’s technology has
the potential to improve product quality and reduce manufacturing costs. This
Phase IIB work will extend Spheryx’s capabilities to meet their needs. The
specific aims of this work are: (1) detect and distinguish contaminants currently
challenging biologics manufacturing including air bubbles and metal particles; (2)
diagnosing handling-induced composition changes including changes caused by
shear forces and by viscosity and temperature variation during processing. Both
hardware and software innovations will be needed to accomplish these additional
capabilities. The results of this work will be a powerful new manufacturing tool
with unique capabilities to meeting critical needs for the biologics industry.
!
!

## Key facts

- **NIH application ID:** 10004914
- **Project number:** 2R44TR001590-04A1
- **Recipient organization:** SPHERYX, INC.
- **Principal Investigator:** Laura A Philips
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,003,165
- **Award type:** 2
- **Project period:** 2016-04-01 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10004914

## Citation

> US National Institutes of Health, RePORTER application 10004914, Instrument for Holographic Characterization of Protein Aggregates (2R44TR001590-04A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10004914. Licensed CC0.

---

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