Results of the finished projects

NEW ANALYTICAL STRATEGIES AND NEW INSTRUMENTAL AND SYSTEM DEVELOPMENTS FOR THE REGULATORY CONTROL OF COSMETIC AND TEXTILE PRODUCTS.

Execution period: February 2016- November 2018

Current status: Finished

Objective of the Project: Development of advanced analytical solutions for the regulatory control of cosmetic and textile products.

• Analytical solutions based on advanced instrumental techniques that allow the coverage of more than 3000 regulated chemical substances in cosmetic products.
• A screening method allowing very rapid detection of substances not authorised for use in cosmetics.
• Our own methods for microbiological control of cosmetics based on the reaction of the O SCA and the screening of volatile substances of microbial origin.
• GC-IMS prototype for the development of a methodology for the in situ analysis of textile products.

Findings obtained:

• We have achieved a portfolio of analytical services for the cosmetic sector, which allows us to cover practically all analyses and validations. In some cases they have even been externally audited by the National Accreditation Entity for accreditation under ISO-17025.
• The technical feasibility of applying a method of qualitative screening to dozens of banned substances has been demonstrated thanks to the application of high-resolution mass spectrometry technology.
• The potential and limitations of GC-IMS coupling technology for the in situ chemical analysis of textile products have been assessed and tested experimentally thanks to a prototype resulting from the development of hardware and software carried out.
• It has been possible to create a stable prototype that can be used to make these developments and it has been possible to identify solvents compatible with this technology to detect arylamines that, due to their chemical characteristics, were not preferential candidates for this technique.
• A more robust, simple and safe arylamine collection and reduction methodology than the one compatible with its application in mobile environments has been developed, either to be detected using GC-IMS or thin layer chromatography, an alternative technique that has been successfully tested.
• Indirect screening using GC-IMS of another substance of great interest in textile control, formaldehyde, has been achieved.
• Where the application of GC-IMS has achieved notable success is in the screening of volatile substances related to microbial contamination of cosmetics, substances that have been identified in this project through GC-MS studies.
• For microbiological controls in cosmetics, a rapid alternative method for self-monitoring based on the SCA technique has been achieved, which has been adapted to the cosmetic matrices and allows rapid screening of negative (compliant) samples, which are logically the vast majority, so that only samples showing traces of genetic material from bacteria, fungi or yeasts would need to be confirmed with classical methods.

Total budget of the project: 983.549,04 euros.

This project has been subsidised by the Galician Innovation Agency (GAIN) through the Program Connect SME to encourage cooperation between SMEs and other agents in the Regional Innovation System, co-financed by the European Commission. European Regional Development Fund (ERDF) and supported by the Ministry of Economy, Employment and Industry.

AUTHENTIFICATION AND SECURITY OF SUSTAINABLE TEXTILES AND DEVELOPMENT OF DEVICES FOR EFFECTIVE ENVIRONMENTAL CONTROL IN THEIR MANUFACTURING

Research project developed by a consortium of 5 Galician SMEs: AMSLAB, MESTRELAB, ORGANISTRY, 2XMIL AND XENOTECHS, with the collaboration of several research groups of the University of Santiago de Compostela (CITIUS, CIQUS and Qual Group of the Faculty of Sciences of Lugo).

Execution period: March 2018 – September 2020

Current status: Completed

Project objective: The main objective of the project is the development of effective and globally marketable solutions to solve specific demands in quality control in the “sustainable fashion” subsector.

Results obtained: At the end of the project, the following have been achieved:

• Develop and market tools for the verification of sustainable fashion, such as the Vegan Test or the Organic Cotton Verification Test.
• Carry out genetic characterization by massive sequencing of 36 cotton cultivars (Gossypium spp).
• Identify physicochemical parameters that, through the application of a range of different laboratory techniques, make it possible to differentiate recycled and virgin fibers from synthetic fibers such as polyester and polyamide.
• The necessary functionality has been implemented in the Mnova ElVis module for the application of machine learning techniques for the comparative analysis of FT-IR spectra of synthetic fibers.
• Markers have been identified to differentiate recycled and virgin synthetic fibers (PET and polyamide) using advanced chemometric tools.
• A machine vision algorithm has been developed that automatically processes the retention filter images to identify and quantify the amount of microfibers retained in the filter, thus eliminating the manual counting process in the microplastics released during washing count test of garments. A web application and web interface has also been developed.
• Develop semi-natural dyes prepared from curcumin and guaiazulene derivatives and eucalyptus leaf extracts and evaluate their dye properties.
• To conclude that no specific chemical risks associated with the recycling of textile fibers are identified.
• Manufacture prototypes of sampling kits based on self-developed fillers consisting of carbon nanotubes and NIPS “non-molecularly imprinted polymers” for the analysis of wastewater from the textile industry.
• Construction of a functional prototype on an ESP8266 Wifi microcontroller programmed in Arduino (open source), equipped with industrial sensors and probes integrated in a housing manufactured by 3D printing to monitor wastewater emissions, consult and explore data in real time through a PWA (progressive web app) compatible with all types of display devices and operating systems, through the application (QWater).
• Android app that allows colorimetric measurements “in situ” of chemical compounds in wastewater by applying a specifically developed method based on the use of Whatman FTA® paper cards and an ultra-portable RGB / LAB sensor.

Total project budget: 1,384,032.10 €

This project has been subsidized by the Galician Innovation Agency (GAIN), through the CONECTA-PEME Program and the European Regional Development Fund within Thematic Objective 1, “Promote technological development, innovation and quality research”, included in the framework of the ERDF Galicia 2014-2020 operational program. In addition, it has the support of the Ministry of Economy, Entrepreneurship and Industry.

Industrial research for the discovery of new immunotherapeutic drugs in the treatment of colon cancer

The project consortium is made up of the companies Oncostellae, GalChimia and AMSlab, with the support of the University of Santiago de Compostela, the LEITAT Technological Center and the companies Palo Biofarma, IDIFARMA and Eurofins.

Execution period: July 2018 – December 2020

Current status: Completed

Project objectives: Discovery and preclinical development of new drugs for the treatment of colon cancer, through the activation of the Immune System (SI), to be used as monotherapies, in combination with each other or with other therapeutic agents.

• Develop new inhibitors of the ALK5 kinase (discovered by GALCHIMIA) and of the TGFβ signaling pathway that are effective in colon cancer animal models and nominate a preclinical candidate (Subproject 1).
• Develop new glucocorticoid receptor antagonists (discovered by ONCOSTELLAE) that are effective in colon cancer animal models and nominate a preclinical candidate (Subproject 2).
• To study the efficacy and synergy of the selected compounds through their mechanisms of action to treat colon cancer under in vitro and in vivo conditions.
• Carry out the Preclinical Regulatory Development of a candidate in each subproject.
• Carry out the Pharmaceutical Development and the preparation of the regulatory documentation of both candidates to place them at the gates of Clinical Phase I.
• Develop, validate and implement new highly selective and sensitive analysis methods that allow the determination of selected drugs, as well as the study of different biomarkers in preclinical samples based on mass spectrometry.
• Achieve a correct exploitation of the results through the application for patents and the disclosure of the results.

Results obtained:

• Based on the results of the NEOGALFARM project (2016–2018), a structural optimization has been carried out that has resulted in the selection of two new candidates, an ALK5 inhibitor and a GR receptor antagonist.
• Analytical methodologies have been developed using high performance liquid chromatography (HPLC) coupled with tandem mass spectrometry (MS / MS) for the determination of both compounds in biological samples.
• Scaling-up of synthetic routes for the production of both compounds on a kilogram scale has been successfully completed. Likewise, analytical methods have been validated for their quality control.
• The toxicity and safety of both candidates have been evaluated in vivo. Neither the ALK5 inhibitor nor the GR antagonist have adverse effects related to respiratory, cardiovascular, and neurological functions. Furthermore, their pharmacokinetic profiles have indicated low systemic plasma levels and preferential absorption in the gastrointestinal tract, which makes these compounds especially indicated for the treatment of colon cancer.
• The regulatory documentation for both candidates has been prepared, in the form of an Investigator’s Manual and Investigative Drug Dossier, for presentation to the Spanish Agency for Medicines and Health Products (AEMPS).
• GMP batches of both candidates have been prepared and their high stability under normal and stress conditions has been confirmed.
• The formulation of the ALK5 inhibitor has been completed and the clinical batch of capsules has been produced for use in the phase I trial that will begin in April 2021 at the Sant Pau Hospital in Barcelona.
• The formulation of the GR antagonist candidate is well advanced, and capsule production is expected to be completed in the next quarter. The phase I clinical trial will begin in September 2021 at the Hospital del Vall d’Hebron in Barcelona.
• An analytical methodology based on bottom-up proteomics and HPLC MS / MS has been developed for the quantification of TGFβ1 in mouse plasma and tumor samples.
• The protection of the intellectual property of the 2 new candidates has been ensured through patent applications, which have been submitted both nationally and internationally.

Total project budget: 1,095,700.00 euros

AMSlab thanks all the members and collaborators of the IO4COLON Project for their involvement and teamwork that have been key to obtaining these results. We also thank GAIN for its support in fostering cooperation between SMEs and the other agents of the Regional Innovation System. The CONECTA-PEME calls have allowed 3 Galician SMEs to lead large-scale projects such as IO4COLON, also demonstrating that in Galicia there is potential to carry out drug discovery projects by having the agents and knowledge necessary for this.

The IO4COLON project has been subsidized by the Galician Innovation Agency (GAIN), through the CONECTA-PEME Program, co-financed by the European Regional Development Fund (ERDF) and supported by the Ministry of Economy, Employment and Industry.