PO POLYME YMER R BA BASE SED D NA NANO NOPHA PHARMACE - - PowerPoint PPT Presentation
A PI PILOT LOT PLANT NT FOR R THE HE PRO RODU DUCTIO CTION N OF PO POLYME YMER R BA BASE SED D NA NANO NOPHA PHARMACE RMACEUT UTICA ICALS LS IN N CO COMPL PLIAN IANCE CE WITH TH GMP GMP NanoPilot has received
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
A PI PILOT LOT PLANT NT FOR R THE HE PRO RODU DUCTIO CTION N OF PO POLYME YMER R BA BASE SED D NA NANO NOPHA PHARMACE RMACEUT UTICA ICALS LS IN N CO COMPL PLIAN IANCE CE WITH TH GMP GMP
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
1.- Introduction 2.- Objectives 3.- NanoPilot’s Consortium 4.- Work Plan Summary
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
Funded under European Union Framework Programme for Research and Innovation Horizon 2020
Na NanoPil ilot is a fo four-ye year long pro roject ject which objective is to se set-up up a pilot lot plant
rating under GMP (Good Manufacturing Practice) for the production of polymer-based nanopharmaceuticals. Pilot plant’s ambition is to accelerate the development of nanomedicine, currently in its infancy within the pharmaceutical sector. 4 res research rch groups, s, 3 SMEs and and 2 industri strial gro roups, have joined forces in NanoPilot. Nine partners that have a significant track record in knowledge creation and innovation in their respective domains of expertise to guarantee th the succe ccess ss of
ropose sed proje ject ct.
Project acronym: NanoPilot Grant Agreement no: 646142 Start date: January 1st, 2015 End date: December 31st, 2018 Project budget: 6.28 M Euro Type: Research and Innovation Action
Introduction
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
The European Technology Platform for Nanomedicine has recorded more re than 700 SMEs/I s/Industr strie ies s worki rking in the field ld of Nan anomed edic icin ine, a number that doubles when including research institutions. Experts in the field have recognized their high igh pote tentia tial l of innova vatio tion, however in most cases, clinica inical l vali lidatio tion is still ll requir ired. The traditional business model of ‘Big Pharma’ has evolved to an Op Open In Innovatio tion (OI (OI) model, in- licensing technology from academia
Academi emia and and in innov
ativ ive SMEs have become ke key players rs in the first stage of the development and proof of concept studies.
Introduction
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
The productio ction of innova vative tive nanopharm rmace ceutica ticals ls in quantity and quality (GMP) required for them to ente ter r clinica inical l trial als s remain ains s a chall allen enge:
plants.
and implement GMP manufacturing. This can limit the capacity of these organizations for advancing their research, and as a consequence, slow slow-down the deve velo lopment of
innovativ tive nanopharm rmaceuti tica cals ls to treat different diseases. In this context, it is urgently needed to to provi vide those SMEs with the tools ls that can help lp them with th the vali lidatio tion of
ir tech chnolo logies ies.
Introduction
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
NanoPilot will se set-up up a fle flexi xible and and adapta table pil ilot pla lant operati rating under GMP GMP for the production of sm small ll batch tches of
lymer- base sed nanopharm rmaceutica ticals ls, which exhibit significant potential in the field of drug-delivery particularly for the design of second generation nanopharmaceuticals.
Objectives
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
OBJECTIVES BASED ON INDUSTRIAL NEEDS
Produ
ion of smal all l GMP bat atches es for r clinic inical al trials ials
The pilot plant will provide the small quantities of products that technology developers will require for full preclinical and first clinical validation
Flex exib ibilit ility and d Adapt aptabilit bility
A design which will look for a compromise between: specialization, flexibility and economic viability.
Focused d on Regula gulatory ry complia plianc nce
The big pharma will require technology which is robust and translatable, that has completed full toxicological preclinical phase and had been validated in first clinical trials. That technology must fulfil strict regulatory requirements.
Objectives
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
SCIENTIFIC OBJECTIVES
Produ
ion of three hree differen rent nano noph pharm armac aceut eutic icals als
A sho hort t inte terfe ferin ing RNA A (siRNA) nanoformulation for the topical treatment of ocular pain associated with dry eye syndrome (DES). A HIV nanova vacci ccine formulated for intranasal vaccination. Hyalu luron ronan base sed spheres. res. A treatment for interstitial cystitis/painful bladder syndrome (IC/PBS).
Integ ntegra ratio ion n of microf rofluid luidic ics in the e plant ant Imple plemen entatio ion n of highly ghly adv dvan anced d charac haracter eriz izatio ion n tec echniq hnique ues
Asymmetri trica cal l Flow w Field ld Flow w Fractio ctionatio tion (A4F): ):
characterize nanoparticles in native conditions.
particles ranging from the nm to the mm with high resolution.
Objectives
Benefits of this technology include:
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
Consortium
PROJECT COORDINATION, FACILITIES OWNER. HYALURONAN SPHERES SPONSOR. HIV VACCINE SPONSOR. SHORT INTERFERING -RNA SPONSOR. MICROFLUIDIC CHIPS DESIGNER AND PROVIDER. MICRO REACTOR DESIGNER AND PROVIDER. QUALITY SYSTEM, GMP, AND LIMS CONSULTANCY. BUSINESS PLAN CREATOR, DISSEMINATION AND EXPLOITATION PLAN DEVELOPER. NANOMATERIALS CHARACTERIZATION EXPERT.
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
Work Plan
WP1:
Definition of nanopharmaceuticals and design of their GMP production process
WP5:
Validation of manufacturing processes and production of nanopharmaceuticals in compliance with GMP
WP2:
Adaptation of the facilities to a nanopharmaceuticals production pilot plant working in compliance with GMP Shipping and batch release Training system implementation Development of a business and dissemination plan Quality system implementation Management
WP3: WP4: WP6: WP7: WP8:
NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142
www.nanopilot.eu