BOZEMAN, MT – JUNE 14, 2017 – BioScience Laboratories (BSLI) is helping antimicrobial product development companies better illustrate their product efficacy by expanding its capabilities for anti-biofilm product testing services.
Biofilm, the build-up of bacteria within a matrix on surfaces, represents a substantial public health risk to individuals across health care, industrial, environmental, energy and agricultural sectors. When not addressed, biofilm can cause chronic infections and serious long-term health issues, leading to significant medical costs for treatment.
The concern is great enough that the U.S. EPA provided a Draft Guidance in 2016 for companies pursuing assessment of antimicrobial products intended to control biofilms on hard, non-porous surfaces. As these companies work to create the next generation of disinfectants, antiseptics, water treatment chemicals and sanitizers, there will be a need to submit data to support effectiveness claims through anti-biofilm substantiation testing.
“The list of potential products that could be eligible to make an anti-biofilm claim is enormous,” said Daryl S. Paulson, Ph.D, MBA, president and CEO of BSLI. “With increasing concerns over cleanliness, infection control, worker safety and consumer risk reduction, more companies are looking to create antimicrobial products. Products such as engineered surfaces, anti-biofilm chemicals, antibiotics, surface preparations, wound care materials, disinfectants and antiseptics are all potential customers for biofilm testing.”
Currently, the FDA does not recognize any assay to evaluate acceptable amounts of biofilm or what constitutes a clinically meaningful reduction in biofilm. In lieu of official guidance, the FDA asks companies to submit testing protocols for studies intended to support anti-biofilm indications. This happens via the pre-submission process which allows companies to receive preliminary feedback and help define a regulatory pathway.
Based on current and potential forthcoming guidance, BSLI expects an influx of testing requests, and has expanded its testing capacity and options accordingly. Each service is designed to evaluate product efficacy, prevention and/or removal of biofilms using in-vitro techniques.
BSLI designs and performs experiments tailored to the needs of each client to quantify biofilm growth and evaluate anti-biofilm treatments specific to industry concerns. Testing capabilities for biofilm evaluation include: