Research, Application, Innovation and SErvices in Bioimaging
The main aim of RAISE is the radiotracers processes production optimization, in order to use them in diagnostic imaging to have informations about the chronic degenerative diseases development, to improve the therapeutic approach enabling the care before the disease occurs its symptoms on patients. The lines of research and the expected results that RAISE will provide are:
- Clinical informations about Parkinson and dementia with Lewy bodies. 18F-DOPA demonstrative production with the traditional process to verify the radiopharmaceutical efficacy in the diagnosis of these diseases. This development line will make possible to achieve the Patent (AIC): ITELDOPA. In this way DOPA becomes a new “early” diagnostic tool absent in Apulia and in central- south Italy.
- Increasing production yield thanks to the aseptic dispensing. The existing machines use autoclaving method for the dispensing of the radiopharmaceutical and make it sterile and injectable. The autoclaving method needs about 40 min and this step involves the formation of chemical impurities, and the production loss of 30%. The RAISE aim is to study and validate an aseptic process that avoids autoclaving increasing the yield (using the different tools Biodecontamination such as UV, Standard Operating Procedures, Biocides, etc). Achieved this goal, a new machine, to exploit this process and that is safer for workers and the environment in drug production and packaging, will be designed.
- Increasing production yield by improving the plant engineering synthesis. Use of microfluidic devices in parallel to increase the production yield. Prototype design of a new patentable synthesis module will be made. After this research project, the synthesis module would be industrialized to be used in production by ITELPHARMA and to be marketed internationally, also through partnership with multinational companies such as GE and IBA.
- Increasing of production yield by changing the synthesis path. In this case the production yield will be improved by changing the reagents and synthesis to get the drug. Consequently, it’s need of design of a new synthesis kit and its prototype implementation in order to obtain a process patent. Also the KIT and the process development line, after the end of the project, will be industrialized, so they can be used in the ITELPHARMA production line and can be sold to radiopharmaceutical multinational companies.
- Excipients Changing for 18F-DOPA. This development line aims to reduce pain in the tracer injection. Changing excipients the stability of the drug into solution at pH closer to that of the blood would increase, so the pain upon injection is eliminated.
- Quality system for GLP authorization. Another important step to obtain a patent in the pharmaceutical field, is the bioequivalence study in vivo (ie the drug made in the alternative way is equivalent to that described in the European Pharmacopoeia) that verifies the 18F-DOPA kinetics and dynamic. In order to make these preclinical studies it’s need set up a laboratory and a quality system for Standard Operating Procedures, Qualification and Validation of Analytical Methods Protocols of the Equipment according with Good Laboratory Practice. Their aims is to validate the processes and resources of the laboratory as GLP by the Institute of Health, in the industrialization phase of this project results. Today in Italy there is no laboratories radiopharmaceutical R&D GLP authorized by the Ministry of Health. In particular, the realization of the R & D laboratory bioimaging will be partial, due to the reduced funding approved. Therefore, only the synthesis laboratory for the preparation and the formulation of the active principles and the control laboratory and quality analysis will be set up. Instead the spaces provided for microPET-TC and for relaying the related laboratory animals will not be set up.
Consequently, bioequivalence GLP studies will be performed at the documented experience laboratory with the subjects Beneficiaries financing of the contribution for this project.
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