project overview: vision, scope and deliverables · industry partnership (mmip) addopt vision ian...
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![Page 1: Project overview: Vision, scope and deliverables · Industry Partnership (MMIP) ADDoPT vision Ian McCubbin, chair of MMIP when ADDoPT proposal was submitted and approved for funding](https://reader036.vdocuments.net/reader036/viewer/2022071214/604203ad00429079ee2bdb52/html5/thumbnails/1.jpg)
Project overview: Vision, scope and deliverablesSean BerminghamProject Director ADDoPTVP Formulated Products, Process Systems Enterprise
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ADDoPT (2015-2019)2
A £20.4m UK Government-Industry-Academia collaboration
“This project has the potential to propel the UK to the forefront of medicinal product design and manufacture”
ABPI & BIA
Part-funded under the Advanced
Manufacturing Supply Chain Initiative (AMSCI*)
04/04/2019 MEETING TITLE, LOCATION
*A BEIS initiative delivered by Finance Birmingham and Birmingham City Council
Instigated by the Medicines Manufacturing
Industry Partnership (MMIP)
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ADDoPT visionIan McCubbin, chair of MMIP when ADDoPT proposal was submitted and approved for funding
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A digitalisation vision supported by key reports
ADDoPT started two years before publication of these reports recognising / confirming the need for development and deployment of Digital Design and Digital Operation solutions
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Digital Design is an integral part of Digital manufacture (Industry 4.0) …
… is the use of an integrated, computer-based systemcomprised of simulation, 3D visualization, analytics and collaboration tools to create product and manufacturing process definitions simultaneously
https://www.plm.automation.siemens.com/global/en/our-story/glossary/digital-manufacturing/13157
https://www.siemens.com/press/pool/de/events/2018/digitalfactory/2018-04-hannovermesse/presentation-press-conference-prior-to-hm18-e.pdf
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ADDoPT scope
Design and control of optimised development & manufacturing processes through data analysis and first principle models
Processes Products Patients
Quality systems
Release profiles
Materials properties
Particle attributes
Surface chemistry
FormulationProcessing rules
Manufacturing classification
Improve / optimise for impact
DownstreamUpstream
Product and Process Design
Product Performance
CrystallisationFiltrationWashingDrying
ActiveIngredient
(API)
MillingBlending
CompactionCoating
Primary Manufacturing - Secondary Manufacturing
A systems-based approach to pharmaceutics
Horizontal integration: Manufacture Product Performance (breaking down silos)
Vertical integration: Length Scales & Design Operation
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See delegate pack for a more detailed description of the vision and benefits for patients and the pharmaceutical industry
28th March 2019 ADDOPT DIGITAL DESIGN SHOWCASE, LONDON
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Development of digital design and digital operation tools usingmechanistic understanding, big data and hybrid approaches
Sele
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Mechanistic understanding Big dataTools developed using
D I
GI
TA
LM
AN
UF
AC
TU
RE Solubility prediction (WP3&5)
Flowability prediction (WP3)
Lattice energy prediction (WP3)
Drug substance manufacture unit operations (WP5)
Leveraging Mechanistic models for Design & Operation. (WP6)
Aggregating data from a mixture of sources to develop, design, and operate processes. (WP6)
Morphology prediction - VisualHabit (WP4?)
Solid form assessment – CSD-Materials (WP5)
Solubility prediction – gSAFT (WP5)
Drug product manufacture unit operations (WP4)
Particle surface visualisation and analysis (WP4&5)
Stability (WP5)
Stability (WP5)
Dissolution & Oral absorption
Wo
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latf
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(W
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Data is typically not ubiquitous nor cheap to generate at the R&D and Engineering stages
Use targeted data driven approaches to fill gaps in mechanistic understanding
E.g. flowability, compressibility, bulk density
Hybrid models
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nMechanistic understanding Big data
D I
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LM
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API
DP
API & DP
BMS1 -Predicting the performance of powders in a loss in weight feeder
Cross Prime -Lamotrigine Case Study
AZ - Modelling of freeze drying processes
AZ 1 -Crystallisation modelling
AZ2 - Utilisation of a process model for twin screw granulation
PFE4 -Assessment of advances in gSAFT
PFE2 - Tablet sticking – role of API properties
PFE5 -Documentation of Modelling Workflow
GSK –System Modeling and Computer Experiments to Identify Design Space
Lattice energy
prediction
CDC digital twin
Application of digital design and digital operation tools > 15 pharma led case studies
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See delegate pack for summaries of six case studies10
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ADDoPT outcomes relevant to digital design and digital operation are available as new software tools or enhancements to existing tools …
Have also worked on integration of tools from various parties, e.g.
CCDC and U. Leeds
STFC and PSE
PSE and PEL
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See delegate pack for an overview of the project outcomes, many in the form of software tools, accessible by ADDoPT and non-ADDoPT partners
28th March 2019 ADDOPT DIGITAL DESIGN SHOWCASE, LONDON