Community Research and Development Information Service - CORDIS


NanoPilot Report Summary

Project ID: 646142
Funded under: H2020-EU.

Periodic Reporting for period 2 - NanoPilot (A Pilot Plant for the Production of Polymer based Nanopharmaceuticals in Compliance with GMP)

Reporting period: 2016-07-01 to 2017-12-31

Summary of the context and overall objectives of the project

The main goal of NanoPilot project is to set-up a flexible and adaptable pilot plant working under GMP guidelines for manufacturing of small GMP batches of investigational medicinal product (IMP), and more specifically polymer based nanopharmaceuticals for preclinical or early clinical stages. During the first reporting period (M1-M18), the NanoPilot consortium has been working in 6 of the 8 Work Packages (WP) (WP1, WP2, WP3, WP4, WP7 and WP8).
The activity has been focused towards achieving that main goal which can be broken down into the following key objectives for this period:
• Adaptation of the current facilities to the requirements for a GMP manufacturing pilot plant.
• Achieving GMP manufacturing of three different products (including technology transfer, characterization and quality control developments).
• Incorporating continuous flow reactors into the pilot plant to improve the current bulk synthesis methods, and provide solutions to current issues related to the scaling-up process.
• Designing an efficient Quality System (QS).
• Training personnel staff in GMP guidelines and designing an organization chart suitable for the pilot plant.
• Developing a dissemination and business plan for the future sustainability of the pilot plant.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Within Work Package 1 the current specifications and lab-scale production procedures of each nanopharmaceutical were collected. Based on that knowledge, a strategy for technology transfer was designed by establishing the steps and data needed to implement a GMP production for each of them. At the same time, the specifications required for the flow reactors were defined in order to translate the bulk procedure into a microfluidics setup.
An audit of the current facilities and requirements for a GMP quality system was done and the gaps to execute in compliance with GMP guidelines the production of the three nanopharmaceuticals were identified.
As part of Work Package 2 the reform project for the current facilities was redacted, and the public tender to select the engineering company to conduct the works was published and awarded according to Spanish and Basque Country legislation. Two meetings with The Spanish Agency of Medicines and Medical Devices took place during this period in order ensure that the planning was in accordance with regulatory guidelines, and check the suitability of the facilities designed to allocate the production processes.
First prototypes of flow reactors have been generated and are ready to be tested.
Appropriate infrastructure to host a Laboratory Information Management System (LIMS) has been created.
In the course of Work Package 3 an organizational chart that enables the correct operation of the pilot plant according to GMP guidelines has been created. In addition training activities regarding GMP guidelines have been started, 9 trainings sessions have taken place.
Within Work Package 4, core documentation (Standard Operation Procedures (SOPs)) to start operating according to the GMP guidelines have been written, the implementation of some of them has already started. Technology transfer phase for two of the three nanopharmaceuticals to be produced has started and both production procedures were repeated at IK4-CIDETEC facilities.
Visual identity and communication materials (brochure, leaflet, website…) were created in the course of Work Package 7. Initial market overview has been completed and business model canvas has been drafted for the future pilot plant.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

During the first 18 months of the project NanoPilot consortium has put their efforts in three main directions:
• Improvement and optimization of the production processes of the three nanopharmaceuticals initially planned in the project. Those processes were developed at lab scale, and there have been studied in detail for their optimization. In addition, new characterization techniques have been established to improve the quality control of the systems.
• New designs of continuous flow reactors have been defined specifically for the production of nanosystems. Those designs will help in the control of most critical process parameters during the process to increase the quality of the final nanopharmaceuticals.
• Design and implementation of a pilot plant that will be specialized in the production of nanopharmaceuticals.
All those actions are planned to increase the impact of the projects:
• Increasing the attractiveness of Europe for advanced medical research, in a global sector as the pharmaceutical.
• Strengthening the competiveness and growth of companies by developing innovations meeting the needs of European Global Markets in three main applications: Ophthalmology, HIV and urology.
• Leveraging of existing investments: The research groups taking part in the consortium have required extensive investments to have reached the current state.
• Improve GMP Nanopharmaceuticals Supply for Enabling Clinical Trials: The pilot plant will be operating under GMP to generate nanopharmaceuticals of sufficient quality to enter clinical trials. A special effort is made to generate a multipurpose pilot plant that will allow the nanoformulation of:
o Non sterile lyophilisates
o Sterile lyophilisates
o Aseptic filling of solutions
• Further Demonstrating the Effectiveness of Nanopharmaceuticals for Medical Therapies.

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