# CFI Pathogen Inactivation of Human Plasma Units

> **NIH NIH R44** · APHIOS CORPORATION · 2020 · $1,789,666

## Abstract

PROJECT SUMMARY
The rapid spread of the Zika virus, which can have a significant impact on neurological disorders in unborn
fetuses and potentially adults, the recent outbreak of the extremely virulent Ebola virus, periodic emergence of
SARS, recurrent outbreaks of potentially pandemic strains of influenza such as H5N1, the continuing epidemic
of MERS and the worldwide AIDS epidemic have highlighted a persistent concern in the health-care
community -- the need for effective pathogen inactivation and removal techniques for human blood plasma and
plasma-derived products. There is no commercially available, FDA-approved technology for the inactivation of
non-enveloped viruses in pooled human plasma and biologics, and only one approved method for units of
plasma, which can inactivate some, but not all known non-enveloped viruses. This dearth of FDA-approved
pathogen inactivation technologies could pose a significant future threat for known and new viruses in human
plasma and biologics. We propose to develop a physical pathogen inactivation technology, CFI™, for the
inactivation of both non-enveloped and enveloped viruses as well as pathogenic bacteria and parasites in
human plasma, plasma protein products and biologics. CFI™ technology is applicable to both pooled human
plasma and units of plasma, the more globally significant focus of the current application.
CFI™ (critical fluid inactivation) utilizes supercritical and near-critical fluids (SuperFluids™ or SFS).
SuperFluids™ are normally gases which, when compressed, exhibit enhanced thermodynamic properties of
solvation, penetration, selection and expansion. These gases are used to permeate and saturate virus and
pathogen particles. The SFS-saturated particles then undergo decompression and, as a result of rapid phase
conversion, virus inflation and rupture at their weakest points. We have demonstrated that the CFI™ (critical
fluid inactivation) process inactivates both enveloped viruses such as MuLV, VSV, Sindbis, HIV (all completely
inactivated), TGE, and BDVD, and the non-enveloped viruses Polio, Adeno, EMC (complete inactivation), Reo,
and Parvo viruses, while preserving biological activity of the CFI-treated product. In research collaboration
with the National Institute of Biological Standards and Control (NIBSC), London, England, our CFI inactivated
more than 4 logs of human Parvovirus B19 (one of the smallest and toughest viruses) in human plasma in a
two-stage CFI™ unit in less than 20 seconds. We have also demonstrated that SFS can disrupt and inactivate
microorganisms such as E. coli, thick-walled prokaryotes such as Bacillus subtilis and tough eukaryotes such
as Saccharomyces cerevisiae at viral inactivation SFS conditions. CFI can be used with viral reduction
methods such as nanofiltration as an orthogonal method of pathogen clearance, and is versatile for refinement
to treat cellular blood. The present data have been generated using prototypes of our pilot-scale CFI unit.
Our Phase I ...

## Key facts

- **NIH application ID:** 9963365
- **Project number:** 5R44HL137605-03
- **Recipient organization:** APHIOS CORPORATION
- **Principal Investigator:** TREVOR P. CASTOR
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,789,666
- **Award type:** 5
- **Project period:** 2019-07-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9963365

## Citation

> US National Institutes of Health, RePORTER application 9963365, CFI Pathogen Inactivation of Human Plasma Units (5R44HL137605-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9963365. Licensed CC0.

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