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 funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142

INDEX 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

Introduction Na NanoPil ilot is a fo four-ye year long pro roject ject which objective is to set-up se up a pilot lot plant operati rating under GMP (Good Manufacturing Practice) for the production of polymer-based nanopharmaceuticals. Funded under European Union Framework Programme for Research Pilot plant’s ambition is to accelerate the development of and Innovation Horizon 2020 nanomedicine, currently in its infancy within the pharmaceutical sector. Project acronym: NanoPilot 4 res research rch groups, s, 3 SMEs and and 2 industri strial gro roups, have Grant Agreement no: 646142 joined forces in NanoPilot. Nine partners that have a Start date: January 1 st , 2015 End date: December 31 st , 2018 significant track record in knowledge creation and innovation Project budget: 6.28 M Euro in their respective domains of expertise to guarantee th the Type: Research and Innovation Action succe ccess ss of of the prop ropose sed proje ject ct. NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142

Introduction The traditional business model of ‘Big Pharma ’ has evolved to an Open In Op Innovatio tion (OI (OI) model, in- licensing technology from academia or SMEs. Aca Academi emia and and in innov ovat ativ ive SMEs have become ke key players rs in the first stage of the development and proof of concept studies. 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. NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142

Introduction 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: • Not easy implementation in existing manufacturing plants. • Lack of resources in small companies to up-scale 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 of in 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 of their ir tech chnolo logies ies. NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142

Objectives 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 of polym 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. NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142

Objectives OBJECTIVES BASED ON INDUSTRIAL NEEDS Produ oduction ion of smal all l GMP bat atches es for r clinic inical al trials ials Focused d on Regula gulatory ry complia plianc nce 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 The big pharma will require technology which is robust and translatable, that has completed full A design which will look for a toxicological preclinical phase and had been compromise between: specialization, validated in first clinical trials. That technology flexibility and economic viability. must fulfil strict regulatory requirements. NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142

Objectives SCIENTIFIC OBJECTIVES Integ ntegra ratio ion n of microf rofluid luidic ics in the e plant ant Produ oduction ion of three hree differen rent Benefits of this technology include: nano noph pharm armac aceut eutic icals als Increased process control • Increased process safety • A sho hort t inte terfe ferin ing RNA A (siRNA) nanoformulation for the topical Small footprint • treatment of ocular pain associated Rapid and robust • with dry eye syndrome (DES). Economical • Imple plemen entatio ion n of highly ghly adv dvan anced d A HIV nanova vacci ccine charac haracter eriz izatio ion n tec echniq hnique ues formulated for intranasal vaccination. Asymmetri trica cal l Flow w Field ld Flow w Fractio ctionatio tion (A4F): ): Hyalu luron ronan base sed spheres. res. A treatment for interstitial - Increasingly used as a separation method to size sort and cystitis/painful bladder characterize nanoparticles in native conditions. syndrome (IC/PBS). - Possibility to analyze a wide variety of macromolecules and particles ranging from the nm to the m m with high resolution. 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, HYALURONAN SPHERES HIV VACCINE SPONSOR. FACILITIES OWNER. SPONSOR. MICROFLUIDIC CHIPS MICRO REACTOR DESIGNER SHORT INTERFERING -RNA AND PROVIDER. SPONSOR. DESIGNER AND PROVIDER. BUSINESS PLAN CREATOR, NANOMATERIALS QUALITY SYSTEM, GMP, DISSEMINATION AND AND LIMS CONSULTANCY. CHARACTERIZATION EXPERT. EXPLOITATION PLAN DEVELOPER. 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: WP2: WP3: WP4: Definition of Adaptation of the facilities to a Quality system Training system nanopharmaceuticals and nanopharmaceuticals implementation implementation design of their GMP production production pilot plant working process in compliance with GMP WP5: WP6: WP7: WP8: Validation of manufacturing Development of a business Shipping and batch release Management processes and production of and dissemination plan nanopharmaceuticals in compliance with GMP 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 Thank you Time for Questions NanoPilot has received funding from the European Union’s Framework Programme for Research and Innovation Horizon 2020, under Grant Agreement no: 646142