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Performance
of 50 Completed ATP Projects
Status
Report - Number 2
NIST SP 950-2
Chapter
3 - Biotechnology
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Aphios
Corporation
(formerly BioEng, Inc.)
Reducing Viral Contamination
in Donated Blood
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| This
ATP project with Aphios Corporation, a small Massachusetts company
founded in 1988 as BioEng, developed technology to improve the quality
of donated blood in the United States. If the technology is fully
developed and widely applied, substantial benefits would accrue to
patients. The transfused blood or other therapeutic substances they
receive would essentially be free of hepatitis virus, human immunodeficiency
virus (HIV, which causes acquired immunodeficiency syndrome, or AIDS),
and other viruses that may contaminate vaccines, donated blood, blood-related
products, medical instruments, and recombinant-DNA proteins. |
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COMPOSITE
PERFORMANCE SCORE
(Based on a four star rating.)
No Stars
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Solving the Problem
of Contaminated Blood
Several sterilization procedures using heat, a chemical, or ultraviolet
radiation are already in use, but each method has drawbacks: it may leave
unsafe levels of some viruses, be very costly, or damage the blood or
plasma. The Aphios sterilization technology, called critical-fluid inactivation
(CFI), uses a fluid such as carbon dioxide that is raised above its critical
temperature and pressure. Above these levels, the substance cannot be
liquefied. In laboratory tests, such fluids exhibit a combination of liquid
and gaseous properties, and they have been found to effectively inactivate
prototypical viruses. Critical-fluid viral inactivation uses low temperatures
and short process times, so it has a minimal impact on blood and blood-related
products. And, at an estimated cost of about $1 per liter, it is much
less expensive than existing technology.
Overcoming Parvovirus
The procedure Aphios developed during the ATP project has been able to
achieve 99.9999 percent inactivation or more for most viruses in 20 seconds
(99.99 percent inactivation by an individual viral inactivation technique
is considered acceptable). The most difficult challenge has been parvovirus.
Parvovirus B19 in
blood and blood products has proven difficult to inactivate, not only
by the CFI process but by others as well. The virus is relatively benign
for patients with healthy immune systems. But it can have serious consequences
for those with weakened immune systems, as well as for pregnant women
and persons with sickle cell anemia. The current Aphios procedure has
achieved 90 percent inactivation of this virus. The company is working
on a five-step procedure that is expected to achieve better than 99.99
percent inactivation.
The blood industry
has established an extremely high standard for new technologies. Therefore,
commercial deployment of the Aphios technology will be much easier if
the company can demonstrate that its technology can inactivate parvovirus
to an acceptable degree. If it succeeds with this task, Aphios will seek
to join a larger pharmaceutical company or consortium to further develop
and commercialize the process, with substantial investment coming from
these sources. In 1998, Aphios sought an arrangement with a consortium
of five pharmaceutical companies to complete development of the CFI process.
If a company wishes to commercialize a product for use with donated human
blood, it must deal with the American Red Cross (ARC), the source of most
blood products used in clinics and hospitals in the United States. Aphios
has signed a letter of intent with the Northeast Region of the ARC to
develop and field-test a viral inactivation prototype for individual units
of blood and is seeking funding for the project.
Health Benefits to
Patients and Those Close to Them
If the technology is fully developed and commercialized, benefits are
expected to accrue to users of blood and blood-derived products that can
be made virus-free with the Aphios technology. Reducing the spread of
viral disease is expected to generate large health-cost savings and related
benefits to the United States. Users will also benefit if the process
based on the new technology is, as expected, less costly than current
decontamination procedures. Economic benefits might also extend to people
who avoid viral disease because users of blood or blood-derived products
decontaminated with the Aphios technology do not become infected and spread
the disease.
Without the ATP funds,
Aphios officials say, the company would not have conducted the project.
Moreover, it would have been impossible for this small company to attract
the interest of the health care company or the American Red Cross.
As this report was
going to press in late 1998, it was learned that the company had reduced
staff and was experiencing financial distress.
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Project
Highlights
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PROJECT:
To develop a critical-fluid viral inactivation process to protect
the nation’s supply of donated blood and blood-related products
from contamination by AIDS, hepatitis, and other viral diseases.
Duration: 7/1/1992 — 6/30/1995
ATP Number: 91-01-0135
FUNDING (in
thousands):
| ATP |
$2,000
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67%
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| Company |
1,000
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33%
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| Total |
$3,000
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ACCOMPLISHMENTS:
Aphios developed a procedure using critical fluids to inactivate
viruses in blood and established that the process is applicable
to a large number of viruses, although with different levels of
effectiveness. The following achievements indicate technical progress
by the company, which:
- applied for
a patent (“Viral Inactivation Method and Apparatus”)
on technology related to the ATP project;
- presented
two papers at conferences on blood-safety issues;
- executed
a letter of intent with the Northeast Region of the American Red
Cross to develop and field-test a virus inactivation prototype
for individual units of blood; and
- submitted
a proposal to a consortium of companies to evaluate the viral
inactivation technology for use in developing products and processes.
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COMMERCIALIZATION
STATUS:
Aphios has not commercialized the process yet. The firm has been
negotiating with a health care company interested in sponsoring
further development and commercialization of the technology. Some
early knowledge benefits have emerged from the project via patent
disclosures and scientific papers.
OUTLOOK:
Commercialization may occur after more R&D work, primarily on
the inactivation of parvovirus. There has been evidence of interest
in the technology by the health-care community in general and by
the American Red Cross in particular. Benefits are expected to accrue
to society if the development of the technology can be completed
successfully. However, given the company’s financial difficulties,
the outlook at this time is uncertain.
Composite
Performance Score:
No Stars
COMPANY:
Aphios Corporation
(formerly BioEng, Inc.)
3-E Gill St.
Woburn, MA 01801
Contact: Trevor P. Castor
Phone: (781) 932-6933
Number of employees: 3 at project start, 17 at the end of
1997
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Return to Table
of Contents or go to next section.
Date created: April
2002
Last updated:
April 12, 2005
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