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Copyright © 2017 Centre for Process Innovation Limited. All Rights Reserved.
CPI’s National Formulation Centre - 1 Year On
Dr. Caroline Kelly & Dr. Dave Berry
National Formulation Centre
2015
UK FORMULATION INDUSTRIES CONNECTING THE ECOSYSTEM
Investor Ready Innovation
Ready
TRL 1-3 Research & Invention Mainly Public
TRL 4-7 Innovation Public/Private Collaboration
TRL 8 & 9 Commercial
Market Private
Future Formulation of Complex Products 2015
UK Formulation Industry & Associated Supply Chain
THE VISION FOR THE NATIONAL FORMULATION CENTRE IS TO CREATE…
An open access, not for profit, Innovation Centre for
Advanced formulated product design and manufacture comprising
A central hub connected to spokes of
World class cross-sector expertise, technology, equipment and skills that
Enables companies of all sizes to accelerate high value products and processes to market underpinned by
A step-change in design capability built on
A deep mechanistic understanding of complex formulated systems
New facility at Netpark now open
Joining up the UK Innovation System
Creating new research infrastructure for the UK
Technical staff with cross-sector expertise
An open access, not for profit, Innovation Centre for
Advanced formulated product design and manufacture
New facility at Netpark now open
Head of Research
Manager - High TP,
Informatics & Modelling
4 Senior Research Scientists; 1 Research
Scientist; 1 Senior Research Technician; 1 Research Technician
Manager - Materials Science
4 Principal Scientists; 1 Senior Research
Scientist; 2 Research Scientists; 2 Senior
Research Technicians
Manager - Nanomaterials &
Composites
4 Principal Scientists; 3 Senior Research
Scientists; 2 Research Scientists; 3 Senior
Research Technicians
Manager - Complex Particles
1 Principal Engineer; 1 Research Scientist; 1
Senior Research Technician
Manager - Process
Technology
2 Principal Engineers/Scientists; 2
Research Engineers/Scientists; 1
Senior Research Technician
Manager - Colloid Science
2 Principal Scientists; 2 Senior Research
Scientists; 2 Research Scientists; 3 Senior
Research Technicians
Operations Manager
8 Team Members
10 Team Members
13 Team Members
4 Team Members
6 Team Members
10 Team Members
Technical staff with cross-sector expertise
POWDER MIXING TEST BED CHARIOT
BATCH TO CONTINUOUS PROCESSING FLEXMANU
COMPLEX LIQUID SCALE-UP PROSPECT CL
NANOFORMULATION SCALE-UP MICROSUN
PAT ENABLED WET GRANULATION PROSPECT CP
POWDER FLOW LEARNING RIG PROSPECT P&F
RADICAL EFFECTS PRODUCT PREDICTIVE DESIGN PROCESS PREDICTIVE DESIGN MANUFACTURABILITY
MODELS MPP
HTE SCREENING
NANOMATERIAL DISPERSION AND STRUCTURING
RAPID STABILITY TESTING MICROSTAR
EMER
GIN
G
CURR
ENT
EMERG
ING
CU
RRENT
Joining up the UK Innovation System…. ….Creating new research infrastructure for the UK
© 2015 Centre for Process Innova tion Lim ited. All Rights Rese rved.
Com plex powders facility ove rview
Dr. David Be rry Manager (Com plex Particles team )
Complex Solids: Strategic vision for the facility
Creating and validating a national open-access development facility to support the development and registration of new products and processes • PAT enabled process understanding to support ‘development for launch’ • Marrying data from multiple sensors to finished product attributes • Facilitating the industrial implementation of innovative process analytics • Data to inform commercial control strategies – real products, real-life situations
Complex Particles Facility
Sat ur day, 26 May 2018
Prospect CP housed with in a ‘con ta inm en t facility We cannot work with bu lk actives ou tside of th is space
Prospect Pack and fill (PF) a lso involved in PAT sensor in tegra tion in frastructu re with in the lab with the ab ility to m easu re bu lk powder flow/ density e tc.
Con tinuous twin screw m ixer rig Ex. Chariot p roject I haven’t included m ore on th is
Prospect CP
Expecting com ple tion in August/Sep t 2019
Continuous granulation facility: What it does • Enable s fast de fin ition of form ula tion processing param e te rs and control stra tegie s for
we t granula ted products
• Granula tion and processing of a ll powders (except h igh ly explosive ), includ ing active
pharm aceutica l ingred ien ts
• High degree of Process Analytica l Tool in tegra tion to enable the applica tion of Quality
by Design (QbD) protocols and sca le up learn ing th rough m ode l based control system s
Blending of powders up to the 5 kg sca le
Con tinuous we t granu la tion
10 g- 5 kg sca le
Particle size reduction
10 g- 5 kg sca le
Physical PAT sensor integration for the Consigm a
Sat ur day, 26 May 2018
Eyecon 2 Particle Size Distribution and shape analysis from Innopharm a
Ka ise r Pha t Ram an probe 6 m m spot size and 785 nm lase r N.B. The a ttachm e n t has be e n fu lly spe cified with in te rlocks/locking scre ws for lase r safe ty
Multieye NIR p robe from Innopharm a
Connection to ConsiGm a (rep lacing flu id bed drie r) Prospect CP
Hardware: PAT sensor communication infrastructure
Sat ur day, 26 May 2018
NB. Software PAT in tegra tion and control is unde r tende r a t p re sen t De ta il of th is can be added soon PAT sensors a re : Trace rco -Density Eyecon- PSD/shape Multieye - IR PhAT- Ram an Supported by m ultip le ‘soft sensors’
Prospect PF: Convey, flow monitoring, pack and fill
Sat ur day, 26 May 2018
Powder storage b in (1000kg sca le )
150 cross feed auge r
Powder sifte r
AFI gravim e tric fille r Check we ighe r- Filling weight 1g to ≈ 10 kg
Recircu la ting conveyor with rinse r
Prospect PF: Convey, flow m onitoring, pack and fill
• Enables de fin ition of p rocessing pa ram ete rs and con trol stra tegies for packaging powders to ensure h igh qua lity from filling line to consum er
• Enables understand ing of e fficiency savings in packing such as m in im ising product giveaway
• Allows understand ing of bu lk product: packaging in te ractions in new packaging
• High degree of Process Analytica l Tool in tegra tion to enable the applica tion of Quality by Design (QbD) protocols and sca le up learn ing
• (such as flow, segregation and a ttrition on conveying)
Sat ur day, 26 May 2018
Key points
• We will soon (by Sep tem ber) have a facility for which we will know the
OEL
• We can work in liqu id and solid form ula tion of APIs
• We will be ab le to p rocess bu lk powders (kgs not tonnes) in the
con ta ined facility
• We can look a t flow, conveying and packing p rob lem s on the tonne
sca le for ‘sa fe r ’ m ate ria ls (h igh OEL)
Sat ur day, 26 May 2018
www.uk-cpi.com
