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Product Name: Mirasol Pathogen Reduction Technology
Product Description
Navigant Biotechnologies is developing techniques that improve the safety of
blood by reducing the pathogens found in collected blood. The unique Mirasol
Pathogen Reduction Technology from Navigant Biotechnologies, applies light and
riboflavin to alter the nucleic acids of pathogens, rendering them inactive.
This is the first single technology that has been shown to inactivate pathogens
in all three major blood components: red blood cells, platelets and plasma.
Riboflavin, a non-toxic and non-mutagenic compound, is ingested in normal
diets. In fact, riboflavin is considered essential for human health. Navigant
Biotechnologies\' primary goal is to use this technology to improve the safety of
the world\'s blood supply.
Benefits of Mirasol PRT
Mirasol Pathogen Reduction Technology offers several key benefits to blood
centers and patients needing blood:
- Simplicity – no removal of residual compounds is required and complex
personnel training is avoided
- Cost effectiveness – because it is an inherently simple process, labor
and overhead costs are minimized
- Natural compound – considered essential for human health, riboflavin is
non-toxic, non-mutagenic and ingested in normal diets
- Inactivation - we have completed a number of studies demonstrating the
ability of riboflavin and light to significantly reduce pathogen
contamination in blood components.
Mirasol PRT System
The Mirasol PRT system from Navigant Biotechnologies is relatively simple.
Riboflavin is mixed into a blood product, which is then exposed to light for a
short period of time – typically less than 10 minutes. This illumination
causes a chemical reaction that prevents the DNA and RNA of the pathogen from
replicating.
The nucleic acids DNA and RNA provide the instructions for copying and
reproducing the pathogen. Viruses, bacteria and other cells with nuclei (e.g.,
white blood cells) are thus inactivated because they are unable to replicate and
spread through the body. Red blood cells, platelets, and plasma, which lack
nucleic acids, are not harmed.
When taken orally, riboflavin is generally regarded as safe (GRAS).
This designation, recognized by the U.S. Food and Drug Administration (FDA),
means a qualified scientific expert has deemed a substance safe for consumption.
Riboflavin is a water-soluble vitamin and is easily broken down and eliminated
by the body. The by-product of riboflavin is lumichrome. Studies have shown that
exposure to lumichrome via blood does not present a risk to transfusion
patients.
The Mirasol PRT system currently does not require removal of residual
riboflavin or photo products. This aspect of Mirasol PRT makes the process
simple to perform. Following treatment, blood components are immediately ready
to use.
Mirasol PRT Equipment and Disposables
Because Mirasol PRT is very simple, the only additional equipment required is
an illuminator. No other equipment is needed for storage or cell washing.
Currently, the Mirasol PRT illuminator in development requires less than three
linear feet of counter space. Navigant is working closely with blood centers to
design a PRT system that meets the size and process requirements of the blood
collection locations.
The disposable sets for Mirasol PRT will vary somewhat depending on the blood
component. However the basic disposable sets will consist of a bag containing
the riboflavin solution, a standard bag for component
collection/mixing/illumination/storage, and (for red blood cells) a bag
containing a nutrient solution to maintain cell quality.
Inactivation Results
Mirasol PRT has been tested on a variety of pathogens implicated in
transfusion transmitted diseases and has demonstrated significant pathogen load
reduction. Pathogens that have been reported to be inactivated include:
Viruses
Enveloped
- Bovine Viral Diarrhea Virus (BVDV)
- Human Immunodeficiency Virus–1 (HIV-1) – Extracellular and Cell
Associated
- Human Immunodeficiency Virus–1 (HIV-1) – Intracellular, Proviral
- Pseudorabies
- Vesicular Stomatitis Virus (VSV)
Non-enveloped
- Hepatitis A
- Porcine Parvovirus
- Canine Parvovirus
Bacteria
Gram Positive
- B. cereus
- S. aureus
- S. epidermidis
Gram Negative
- E. coli
- K. pneumoniae
- P. aeruginosa
Parasites
- Plasmodium Falciparum (Malaria)
Other
- Graft versus Host Disease (GvHD)
- Jurkat Cells
Company Details
Founded in 2002, Navigant Biotechnologies is a wholly owned subsidiary of
Gambro, Inc., global leader in renal care, healthcare services, and
blood-component technologies. In 1998, Gambro subsidiary, Gambro BCT, started a
research program... more
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