Periodic Reporting for period 1 - EARTH (Environmentally friendly Alternative to Revolutionise the use of formaldehyde in The Histopathology (human tissue) fixative market.)
Période du rapport: 2018-03-01 au 2018-08-31
The Problem:
At present Health care workers use formalin on a daily basis for the microscopic examination of tissue in order to study the manifestations of disease, this falls under a category of science known as histopathology. In this process Human tissue biopsy samples are taken and ‘fixed’ in a formaldehyde solution fixative, known as Formalin. The process is performed in hospitals around the world every day and it presents a problem as the Healthcare workers are exposed to formaldehyde for 8 hours a day every day.
European Chemicals Agency has classified Formalin as a Class 1b carcinogen: EC number: 200-001-8 CAS number: 50-00-02. The use of Formalin is regulated by the Carcinogens Directive in EU workplaces, exposure levels have been reduced from 4ppm to 0.4ppm over an 8h period and 2ppm to 0.2ppm for a 15min period. Hazardous substances carry significant risks to the user such as inhalation risk (carcinogenic) and skin irritation issues (corrosion). Hazardous substances also pose significant risks of contamination to the wider environment making it costly to dispose of.
Importance to Society:
This project offers the histopathology industry the opportunity to stop using a hazardous, environmentally damaging substance by converting to a 100% Eco friendly, non carcinogenic formulation called Fixocare.
Overall Objectives:
Technical: Conduct extensive clinical validation on a large variety of samples tissue types.
Intellectual Property: Develop a strong IP strategy ensuring the company has adequate protection to develop the product commercially whilst having the ability to share the knowledge it has created.
Regulatory : In order to for the project to become commercially successful the product would have to meet the regulatory standards required by each of the global markets identified for target.
Market Assessment: Motivation, market needs, and business opportunity together with the commercial plan need to be outlined.
At present Health care workers use formalin on a daily basis for the microscopic examination of tissue in order to study the manifestations of disease, this falls under a category of science known as histopathology. In this process Human tissue biopsy samples are taken and ‘fixed’ in a formaldehyde solution fixative, known as Formalin. The process is performed in hospitals around the world every day and it presents a problem as the Healthcare workers are exposed to formaldehyde for 8 hours a day every day.
European Chemicals Agency has classified Formalin as a Class 1b carcinogen: EC number: 200-001-8 CAS number: 50-00-02. The use of Formalin is regulated by the Carcinogens Directive in EU workplaces, exposure levels have been reduced from 4ppm to 0.4ppm over an 8h period and 2ppm to 0.2ppm for a 15min period. Hazardous substances carry significant risks to the user such as inhalation risk (carcinogenic) and skin irritation issues (corrosion). Hazardous substances also pose significant risks of contamination to the wider environment making it costly to dispose of.
Importance to Society:
This project offers the histopathology industry the opportunity to stop using a hazardous, environmentally damaging substance by converting to a 100% Eco friendly, non carcinogenic formulation called Fixocare.
Overall Objectives:
Technical: Conduct extensive clinical validation on a large variety of samples tissue types.
Intellectual Property: Develop a strong IP strategy ensuring the company has adequate protection to develop the product commercially whilst having the ability to share the knowledge it has created.
Regulatory : In order to for the project to become commercially successful the product would have to meet the regulatory standards required by each of the global markets identified for target.
Market Assessment: Motivation, market needs, and business opportunity together with the commercial plan need to be outlined.
Following our customer concerns and a literature review, a non-hazardous alternative fixative to 10NBF was sought, following further research several non-hazardous raw materials were found from renewable sustainable resources and these materials were used as a basis to develop the fixative solution. The batches of Fixocare have been produced and compared with 10NBF in the fixation of Porcine tissue. The samples were fixed, sectioned and stained, the slides were then compared for colour, microtomy, clearing, cellular detail and staining showing promising results.
The next step was to put additives in the solution to control bacterial and fungal degradation of the fixative and tissue samples. The part of the project is a time study as the tissue needs to be preserved, the best performing solutions are still working well with the preservation of the tissue.
At this point Serosep will narrow its feasibility to a solution that will be taken forward to clinical validation with human tissue. The process of assigning a clinical validation partner has already begun and Serosep is in the middle of preparing its patent application to protect the knowledge developed. Serosep is also widening the trademark protection to cover the rest of Europe and America. Finally, a detailed marketing strategy and regulatory strategy has been developed for the commercialisation of the product.
The next step was to put additives in the solution to control bacterial and fungal degradation of the fixative and tissue samples. The part of the project is a time study as the tissue needs to be preserved, the best performing solutions are still working well with the preservation of the tissue.
At this point Serosep will narrow its feasibility to a solution that will be taken forward to clinical validation with human tissue. The process of assigning a clinical validation partner has already begun and Serosep is in the middle of preparing its patent application to protect the knowledge developed. Serosep is also widening the trademark protection to cover the rest of Europe and America. Finally, a detailed marketing strategy and regulatory strategy has been developed for the commercialisation of the product.
Development of the formulation: We have passed some major milestones in relation to the formulation of Fixocare, we have identified a raw material which will allow for the development of the first water soluble fixative solution to rival 10NBF. This was one of the main goals in this project. The raw material is plentiful and readily available in Ireland, it is also relatively inexpensive which makes Fixocare viable alternative to 10NBF.
Bactericidal and fungicidal additives: Any fixative that will rival 10NBF must have bactericidal and fungicidal properties to ensure the tissue samples will not degrade when they are in the solution. We have found additives that will give Fixocare these properties and will not impede the fixation of the tissue samples.
Environmentally friendly: Fixocare is based on a natural raw material which has no adverse affect on the environment, in order to develop a final product which remains environmentally friendly. It is important to use additives which are also natural and non-hazardous to the environment. We have found additives with bactericidal and fungicidal properties when used in the correct concentration will not impact on the environment.
Outcome:
A solution has been developed that is completely natural water soluble and environmentally friendly that is preserving and fixing animal tissue comparable to formalin
Bactericidal and fungicidal additives: Any fixative that will rival 10NBF must have bactericidal and fungicidal properties to ensure the tissue samples will not degrade when they are in the solution. We have found additives that will give Fixocare these properties and will not impede the fixation of the tissue samples.
Environmentally friendly: Fixocare is based on a natural raw material which has no adverse affect on the environment, in order to develop a final product which remains environmentally friendly. It is important to use additives which are also natural and non-hazardous to the environment. We have found additives with bactericidal and fungicidal properties when used in the correct concentration will not impact on the environment.
Outcome:
A solution has been developed that is completely natural water soluble and environmentally friendly that is preserving and fixing animal tissue comparable to formalin