Assay - A laboratory test to find and measure the amount of a specific substance or
characteristic.
Bioactive Coatings - Coating technology containing properties that elicit a biological
response.
Biofilm - A layer of microoganisms on an aqueous surface protected within a matrix of polysaccharides
and glycoproteins secreted by the organisms. These microorganisms have distinct physiological properties
separate from free-floating microorganisms.
Biofilm Inhibition - The ability of an entrapped agent to resist or defeat biofilm formation.
Bone Morphogenic Protein (BMP) - Identified by Marshall Urist in the 1960's, these bone surface
proteins have been shown to initiate and accelerate bone healing. They occur naturally, but recently
have been synthesized in the laboratory and are now highly successful products, being marketed for
multiple orthopedic, spinal, and dental applications.
Center for Biofilm Engineering - Bacterin was founded in 1997 as a spin-off from the Center for
Biofilm Engineering (CBE) at Montana State University. CBE is a National Science Foundation
Engineering Research Center which has an 11-year mandate to concentrate on fundamental scientific
questions. The CBE's mission is to understand and control biofilm, and it has invested over
$80 million in the research and development of biofilm technology.
Coating Release Rates - The time it takes to release drugs, as well as the amount of drug,
into the body from a coated medical device.
Drug Eluting Coatings - Polymer coating technology with the ability to disperse drugs over
time at efficacious levels.
Entrapped Agent - A drug or other compound that impregnates the polymer coating found on a
medical device; the active molecule designed to be released by the coating.
High-burst Effect - A technique where a coated medical device releases over 30% of its
entrapped drug within a 24-hour period.
Hydrophilic Surface - A water soluble surface. A hydrophilic surface on a medical device allows
for easier insertion of the device into the body.
Inhibitory Release Profile - The ability of an entrapped agent to supress the undesired
biological response.
In Vitro - In the laboratory (outside the body). The opposite of in vivo (in the body).
Submission Process (520-K) - U.S. Food and Drug Administration submission for approval of a
medical device based on a predicated or existing medical device. The FDA takes 90 days to
either approve or comment on the submission. The 510 (k) submission process does not require
clinical trials.
Thrombus - The formation or presence of a blood clot inside a blood vessel.
Thrombus Formation - Clotting formation on a medical device or vessel wall that can interfere
with the device's ability to function properly and can lead to patient injury.
Glossary of terms was adapted from the National Cancer Institute Dictionary of Cancer Terms
located at www.cancer.gov and from data files at Bacterin International, Inc.
What is biofilm?
The plaque that forms on your teeth and causes tooth decay is a type of bacterial biofilm.
The "gunk" that clogs your drains is also biofilm. If you have ever walked in a stream or
river, you may have slipped on the biofilm-coated rocks.
Biofilms form when bacteria adhere to surfaces in aqueous environments and excrete a slimy,
glue-like substance that can anchor them to all kinds of material: metals, plastics, soil
particles, medical implant materials, and tissue. A biofilm can be formed by a single
bacterial species, but more often biofilms consist of many species of bacteria, fungi,
algae, protozoa, debris or corrosion products.
Essentially, a biofilm may form on any surface exposed to bacteria in the presence of
water. Once anchored to a surface, biofilm microorganisms carry out a variety of detrimental
or beneficial reactions (by human standards), depending on the surrounding environmental conditions.
What is important about biofilm?
You may not be familiar with the term "biofilm," however you encounter it on a regular basis.
Many bacteria are planktonic - they individually float around in water; microbiologists since
the time of Pasteur have conducted most of their bacterial studies using suspended bacterial
cultures. However, the bacteria that typically cause us problems are not planktonic, but
sessile - attached to a surface - and living in biofilms. Once bacteria attach to a surface,
they change. They begin to excrete a slimy material from which the word biofilm was coined.
Although invisible, other changes made by these attached, slimed bacteria are profound: they
"switch on" an entirely different set of genes and effectively make themselves into a different
organism. If researchers continue to study cells in suspended cultures when the actual problems
involve biofilm bacteria, the control strategies derived from those studies will target what,
phenotypically, amounts to the wrong organism. Biofilms are implicated in many human bacterial
infections. Bacterial biofilms cause fouling, product contamination, equipment failure, and
decreased productivity due to downtime for system cleaning and replacement. Substantial evidence
demonstrates that control strategies based on suspended cells are less effective against biofilm
cells. Antibiotic doses which kill suspended cells, for example, must be increased as much as 1,000
times to kill biofilm cells, the organisms most likely injure or kill an infected patient. Antimicrobial
disinfection and kill rates for biofilm cells lag far behind those for planktonic organisms.
Management strongly believes that a better understanding of biofilm science, cell characteristics
and behavior, will reap significant rewards for Bacterin as it designs new strategies, techniques
and products to better manage biofilm in multiple settings.
