PERFORMANCE
OF
COMPLETED
PROJECTS
STATUS REPORT
NUMBER 1
NIST SPECIAL
PUBLICATION 950-1
Economic
Assessment Office
Advanced Technology Program
Gaithersburg, Maryland 20899
William
F. Long
Business Performance Research Associates, Inc.
Bethesda, Maryland 20814
March
1999
CONTENTS
Acknowledgements
Executive Summary
Introduction
CHAPTER
1 - Overview of Completed Projects
Characteristics
of the Projects
Timeline of Expected ATP Project
Activities and Impacts
Gains in Technical Knowledge
Dissemination of New Knowledge
Commercialization of the New Technology
Broad-Based Economic Benefits
CHAPTER 2 - Biotechnology
Aastrom Biosciences, Inc.
Aphios Corporation
Molecular Simulations, Inc.
Thermo Trilogy Corporation
Tissue Engineering, Inc.
CHAPTER 3 - Chemicals and Chemical Processing
BioTraces,
Inc.
CHAPTER 4 - Discrete Manufacturing
Auto
Body Consortium (Joint Venture)
HelpMate Robotics, Inc.
PreAmp Consortium (Joint Venture)
Saginaw Machine Systems, Inc.
CHAPTER 5 - Electronics
Accuwave
Corporation
AstroPower, Inc.
Cree Research, Inc.
Cynosure, Inc.
Diamond Semiconductor Group, LLC
FSI International, Inc.
Galileo Corporation
Hampshire Instruments, Inc. (Joint Venture)
Illinois Superconductor Corporation
Light Age, Inc.
Lucent Technologies, Inc.
Multi-Film Venture (Joint Venture)
Nonvolatile Electronics, Inc.
Spire Corporation
Thomas Electronics, Inc.
CHAPTER 6 - Energy and Environment
American
Superconductor Corporation
Armstrong World Industries, Inc.
E.I. duPont de Nemours & Company
Michigan Molecular Institute
CHAPTER 7 - Information, Computers, and Communications
Communication Intelligence
Corporation #1
Communication Intelligence Corporation #2
Engineering Animation, Inc.
ETOM Technologies, Inc.
Mathematical Technologies, Inc.
Torrent Systems, Inc.
CHAPTER 8 - Materials
AlliedSignal, Inc.
Geltech Incorporated
IBM Corporation
APPENDICES
Appendix
A: Development of New Knowledge and Early Commercial Products
and Processes
Appendix
B: Terminated Projects
END NOTES
End Notes
Click here
for PDF version of report.
Return to Main Page.
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Aphios Corporation
(formerly BioEng, Inc.)
Reducing Viral Contamination in Donated Blood
| 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. |
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.
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 |
67% |
| Company |
1,000 |
33% |
| Total |
$3,000 |
|
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 to 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.
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.
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 Top of Page
Go to other sections of Chapter 2:
BIOTECHNOLOGY
A Patient-Friendly Approach to Human Cell
Transplantation
Reducing Viral Contamination in Donated Blood
Powerful Software for Designing New Molecules
and Therapeutic Drugs
Bioengineering of a Safe, Organic/Chemical
Insecticide
Prostheses Made of Biomaterials That Regenerate
Body Parts
Date created:
March 1999
Last updated:
April 12, 2005
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