GMP Pilot Plant - Cidetec · A design which will look for a compromise between: specialization,...
Transcript of GMP Pilot Plant - Cidetec · A design which will look for a compromise between: specialization,...
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© CIDETEC 2017
Iraida Loinaz Nanomedine Business Manager
GMP Pilot Plant
Facilities and capacities 19/09/2017
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2 C O N F I D E N T I A L
The production of innovative nanopharmaceuticals in quantity and quality (GMP)
required for SMEs to enter clinical trials remains a challenge:
•! Medium size companies with limited R&D facilities, use their existing manufacturing plants, which are too big and too busy for R&D purposes.
•! Small companies lack of resources to up-scale and implement GMP manufacturing.
The Problem
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3 C O N F I D E N T I A L
NanoPilot is a four-year long project which objective is to set-up a pilot plant operating under GMP (Good Manufacturing Practices) 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 research groups, 3 SMEs and 2 industries, all of them with significant track record in knowledge creation and innovation in their respective domains of expertise, have joined forces in NanoPilot to guarantee the successful outcome of the proposed project
NanoPilot
Funded under European Union Framework Programme for Research and Innovation Horizon 2020
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
The research from the NanoPilot project leading to these results has receiving funding from the EU Framework Programme for Research and Innovation HORIZON 2020 under Grant Agreement 646142.
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4 C O N F I D E N T I A L
Objectives NanoPilot will set-up a flexible and adaptable pilot plant operating under GMP for the production of small batches of polymer based nanopharmaceuticals, which exhibit significant potential in the field of drug-delivery particularly for the design of second generation nanopharmaceuticals.
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5 C O N F I D E N T I A L
Objetives based on industrial needs
Flexibility and Adaptability
A design which will look for
a compromise between:
specialization, flexibility and
economic viability.
Production of small GMP batches for clinical trials
The pilot plant will provide the
small quantities of products that
technology developers will
require for full preclinical and
first clinical validation
The pilot plant will provide the
small quantities of products that
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.!
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6 C O N F I D E N T I A L
Dedicated to technology transfer from lab to pilot scale – Unlike CMOs which are interested in the production of big batches.
Cost-effective: Includes small equipment to produce only required amount of doses.
Flexible to the customer needs: Campaign production will allow the implementation of different processes in the same facilities.
Cost-effectiveCost-effectiverequiredrequired amount
The Pilot Plant
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7 C O N F I D E N T I A L
•! Understand the process by DoE (process characterization).
•! Development and scaling. •! QC strategy planning. •! QC processes development. •! Verification and validation. •! Sterility – Validation.
Technology transfer / Design of Manufacturing process
Launching Stage& Excution stage (I)& Excution stage (II) – GMP&
•! Data Collection and Gap analysis.
•! Current lab process evaluation.
•! Starting materials (providers).
•! Manufacturing. •! Packaging. •! ! •! !
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8 C O N F I D E N T I A L
Polymer Nanosystem Characterisation: difficulties
A4F-MALS-RI SEC-RI SEC-triple detector
NanoZS Malvern
Vasco 2 Cordouan Technologies
90 Plus Brookhaven
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9 C O N F I D E N T I A L
Polymer Nanosystem Characterisation: difficulties
DLS Malvern Cordouan Technologies
Brookhaven
Model NanoZS Vasco 2 90 plus
Observation angle 173º 135º 90º
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10 C O N F I D E N T I A L
Continuous flow reactors
Cost-effective production
Batch production
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11 C O N F I D E N T I A L
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Production
QC
Flexible to customer needs
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12 C O N F I D E N T I A L
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QC Area
Storaging Area Packaging
Production Area
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13 C O N F I D E N T I A L
Hyaluronan based particles
Peptidic antigens A short interfering RNA (siRNA)
nanoformulation
Production of three different
nanopharmaceuticals A treatment for
interstitial cystitis/painful bladder
syndrome (IC/PBS).
A HIV nanovaccine formulated for
intranasal vaccination
Topical treatment of ocular pain associated with dry eye syndrome
(DES).
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14 C O N F I D E N T I A L
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© CIDETEC 2017