Development and Characterisation of Antimicrobial Blue Light for Safe Decontamination of Blood Transfusion Products
Lead Research Organisation:
University of Strathclyde
Department Name: Electronic and Electrical Engineering
Abstract
Bacterial contamination of blood components is a major complication for transfusion medicine, resulting in wasteful discarding of products, and health-risks for recipients of contaminated blood (with up to 20% of all donor blood being contaminated in developing countries). Current pathogen reduction technologies (PRT) use UV-light and/or chemicals, however these can be detrimental and cause adverse effects. In the UK, concerns are mainly associated with wasteful discarding of contaminated blood components (particularly platelets due to their storage at 20-24C), and also the compatibility of imported PRT-treated plasma products.
Antimicrobial 405-nm violet-blue light has great potential as a novel alternative PRT. The low energy 405-nm photons are particularly suited to decontamination of sensitive blood components, and their higher penetrability facilitates decontamination of pre-bagged transfusion products - a highly desirable feature unable to be achieved using existing PRTs.
This project will develop this antimicrobial technology for pathogen reduction of blood transfusion products. Collaborative work between the supervisor and the US Food and Drug Administration (US FDA) has resulted in the first known publication documenting the antimicrobial efficacy of 405-nm light for decontamination of blood plasma, and the filing of joint IP between the University and US FDA. This project will significantly advance the fundamental findings of the earlier work, and will focus on the optical and engineering design and compatibility of 405-nm light for decontamination of pre-bagged blood transfusion products, with particular focus on blood plasma and platelets.
The project aims and objectives will include the following:
- An in-depth scientific and technical literature review to establish the standard treatment and storage procedures for blood transfusion products, including an evaluation of the advantages and limitations of currently used technologies/protocols.
- Small scale testing to characterise the in vitro quality of light-treated plasma and platelets, with the aim of establishing 'safe' upper and lower exposure limits which can be used for decontamination whilst retaining blood functionality. These limits are important to ensure compatible treatment of the blood products (high enough to ensure antimicrobial efficacy whilst low enough to ensure retention of haematological structural and functional capability). Tests will include antimicrobial efficacy testing, through generation of inactivation kinetics, and assessment of protein stability, through western blotting, gel electrophoresis and ELISA techniques.
- Design and build of a treatment cabinet suitable for uniform exposure of blood transfusion bags. Considerations for investigation will include: appropriate LED sources and optical components; cooling/thermal management; irradiance profiling; bag treatment configurations (single bag, multi- bag options); operational settings (programmable selection of differing treatment options); and operator and blood product safety considerations.
- Irradiance profiling, using COMSOL Multiphysics software, within the designed cabinet will be conducted in order to optimise LED configurations and exposure of single and multiple transfusion bags.
- Prototype systems will be designed to investigate various treatment options for plasma and platelets, e.g. short duration, high intensity treatment of platelets prior to storage versus continuous, low irradiance treatment as part of standard storage prior to use. Upper and lower irradiance limits for treatment of blood components will be used for guidance of the compatible operating ranges.
- Investigations to ensure that light exposure does not cause degradation of blood storage bags. The surface morphology, gas permeability, breakage rates, and potential for plasticizer leeching, using HPLC, will be evaluated pre- and post-exposure.
Antimicrobial 405-nm violet-blue light has great potential as a novel alternative PRT. The low energy 405-nm photons are particularly suited to decontamination of sensitive blood components, and their higher penetrability facilitates decontamination of pre-bagged transfusion products - a highly desirable feature unable to be achieved using existing PRTs.
This project will develop this antimicrobial technology for pathogen reduction of blood transfusion products. Collaborative work between the supervisor and the US Food and Drug Administration (US FDA) has resulted in the first known publication documenting the antimicrobial efficacy of 405-nm light for decontamination of blood plasma, and the filing of joint IP between the University and US FDA. This project will significantly advance the fundamental findings of the earlier work, and will focus on the optical and engineering design and compatibility of 405-nm light for decontamination of pre-bagged blood transfusion products, with particular focus on blood plasma and platelets.
The project aims and objectives will include the following:
- An in-depth scientific and technical literature review to establish the standard treatment and storage procedures for blood transfusion products, including an evaluation of the advantages and limitations of currently used technologies/protocols.
- Small scale testing to characterise the in vitro quality of light-treated plasma and platelets, with the aim of establishing 'safe' upper and lower exposure limits which can be used for decontamination whilst retaining blood functionality. These limits are important to ensure compatible treatment of the blood products (high enough to ensure antimicrobial efficacy whilst low enough to ensure retention of haematological structural and functional capability). Tests will include antimicrobial efficacy testing, through generation of inactivation kinetics, and assessment of protein stability, through western blotting, gel electrophoresis and ELISA techniques.
- Design and build of a treatment cabinet suitable for uniform exposure of blood transfusion bags. Considerations for investigation will include: appropriate LED sources and optical components; cooling/thermal management; irradiance profiling; bag treatment configurations (single bag, multi- bag options); operational settings (programmable selection of differing treatment options); and operator and blood product safety considerations.
- Irradiance profiling, using COMSOL Multiphysics software, within the designed cabinet will be conducted in order to optimise LED configurations and exposure of single and multiple transfusion bags.
- Prototype systems will be designed to investigate various treatment options for plasma and platelets, e.g. short duration, high intensity treatment of platelets prior to storage versus continuous, low irradiance treatment as part of standard storage prior to use. Upper and lower irradiance limits for treatment of blood components will be used for guidance of the compatible operating ranges.
- Investigations to ensure that light exposure does not cause degradation of blood storage bags. The surface morphology, gas permeability, breakage rates, and potential for plasticizer leeching, using HPLC, will be evaluated pre- and post-exposure.