Research and Development projects
- Beginning of project: 1st June 2013
- Estimated timeline : 36 months
- Global Budget : 5M€, of which 3,8 is European support
- Clean Cells’ investment: 1,3M€
Phagoburn is a European research project, financed by the European commission, which is destined to evaluate phago therapy, the therapeutic use of bacteriophages, the natural viruses of bacteria.
This project aims at evaluating a therapy based on the use of two bacteriophage cocktails, for the treatment of burns infected by the bacteria, Escherichia coli and Pseudomonas aeruginosa, in clinical trial phase 1-2, carried out in France, Belgium and Switzerland.Furthermore, the results obtained in terms of efficacy and safety which will play a role in the drawing up of regulatory directive for phagotherapy.
The use of phages appears to offer great promise as a complementary treatment to antibiotics, due to the ever growing problem of antibiotic-resistant bacteria in the hospital environment.
The role of Clean Cells and the different partners
Phagoburn is a collaborative project that is made up of 5 principal partners from 3 different European countries:
- The French Ministry of Defence (the co-ordinator of the project)by means of its Service for Military Health and The Percy Military hospital( The Burns Unit) .
- The company Pherecydes Pharma (creator of the project) has chosen and developed the bacteriophage cocktails used in this project.
- Clean Cells, is in charge of the production and the quality control of the bacteriophage cocktails in compliance with Good Manufacturing Practices (GMP).
- The Royal Belgium Military Academy, in the Queen Astrid Military Hospital and more precisely its Burns Unit.
- The Reference centre, the Serious Burns Unit in Lausanne (Switzerland), in the University Hospital Vaudois (CHUV).
The other groups involved in this project are : CHU Nantes (France), Centre hospitalier Saint Joseph et Saint Luc (France), Grand Hôpital de Charleroi – Loverval (Belgium), CHU Liège (Belgium), Statitec (France), PhagEspoirs (France), France Europe Innovation (France).
- Beginning of the project: March 2012
- Global Budget: 80 M€, of which 30 M€ is financed by a programme of investment for the future.
- Clean Cells’ investment: 1,3M€
C4C is a specific research and development project coordinated by the society CellForCure (a branch of the Laboratory of Biological fractionation – LFB) who aim to put in place the first French technical facility for the industrialisation of cell therapeutics. This project has been chosen as a National Research and development project as part of the Programme for investments in the future (PIA). This collaborative project has been co-approved by the centre, Atlanpole Biotherapies.
The objective is to produce cell therapeutics for autologous/allogeneic cell therapy projects and to validate the proof of concept by the production of 5 new medical therapies (ATMP).The final goal is to build the industrial sector of cell therapy in France.
Ultimately, this research project will contribute to provide solutions for the treatment of numerous diseases, such as some types of diabetes or cancer: pericardial failure and incontinence would be treated in the future by replacing failing cells by functional cells.
The role of Clean Cells
Clean Cells is involved in this project for the development and validation of Quality Control methods dedicated to analyze the genetic stability of the Advanced Therapeutic Medicinal Product (ATMP). For this purpose, Clean Cells is providing an integrated service for karyotyping. With a highly skilled scientific team and innovative tools, Clean Cells is responding to quality issues closely associated with the industrialization of ATMP.
- Beginning of the project: October 2011
- Estimated timeline : 4 years
- Global budget : 2,5 M€
- Clean Cells’ investment: 1, 3 M€
The use of monoclonal antibodies was a major breakthrough in the treatment of a wide array of diseases, especially cancer, autoimmune, and inflammatory diseases. They constitute a major class of drugs and an increasing investment in the research and development and are deployed to generate new and innovative therapeutic antibodies.
In the context of the quality control of therapeutic antibodies, the project premium ADCC, coordinated by Clean Cells, aim to improve the tools to measure the antibody dependent cell cytotoxicity (ADCC) and to develop a non-radioactive standardized method, in compliance with the current regulatory requirements.
Clean Cells has established an agreement with the INSERM laboratory UMR892 from Nantes allowing the use of standardized ADCC effector cell population as an innovative tool to validate the therapeutic efficacy of antibodies. These effector cells are human modified lymphocyte T expressing the antigen CD16, which is the receptor of antibodies involved in the ADCC mechanism.
The Premium ADCC research program is focused on the optimization and standardization of the ADCC assay using these innovative effectors cells, and benefits from a financing scheme FUI (uniquely interministerial funds) involving Clean Cells, LFB Biotechnologies, INSERM UMR892 ( Nantes) and UMR CNRS 7292 GICC from Tours. Beyond the optimization and in the in depth characterization of these effectors cells, this program is also focused on the development of a non-radioactive ADCC measurement method.
The use of standardized effectors cells, in replacement of primary cells, purified from human blood currently used for such assays, brings to the forefront a new and relevant assay which answers the question of the reproducibility of the method, a key requirement in the measurement of a biological activity of therapeutic antibodies. The main area of application is in the screening of candidate therapeutics, and the batch release of antibody therapeutics, according to the regulatory requirements.
Furthermore, the ADCC non-radioactive method developed by Clean Cells, will have to reach the stringent requirements in term of sensitivity, accuracy and reproducibility, and reflect closely the ADCC biological process. Such a method fulfills the urgent need to reduce the current restrictions (contamination risk of the personnel and environment, management of supply and waste of radioactive material), linked to the use of 51Cr, the radioactive component used in the current reference method.