COMPANY OVERVIEW

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Location – Cardiff, Wales, UKFounded 2004

PROCESSCHEMISTRY SERVICES

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MANUFACTURING CONTROL

ROUTE DEVELOPMENT

PROCESS OPTIMISATION

PROCESS ANALYTICS

CUSTOM SYNTHESIS

ROUTE SCOUTING

QUALITY BY DESIGN

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MM1117-4 linear cooling followed by warm up to encourage growth

0.0

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1 31 61 91 121 151 181 211 241 271

Time (minutes)

Te

mp

era

ture

(°C

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Tu

rbid

ity

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Temperature (°C) Turbidity (%)

MM1117-4 non-linear cooling, exponent = 0.2

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1 31 61 91 121 151 181 211 241 271

Tim e (m inutes)

Tem

per

atu

re (

°C)

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Tu

rbid

ity

(%)

Temperature (°C) Turbidity (%)

MM1117-4 non-linear cooling, exponent = 5

0.0

20.0

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80.0

100.0

120.0

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1 31 61 91 121 151 181 211 241 271

Tim e (m inutes)

Te

mp

era

ture

(°C

)

0.0

20.0

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Tu

rbid

ity

(%)

Temperature (°C) Turbidity (%)

CRYSTALLISATIONPROCESS R&D - CONTROLLED STUDIES

Process Crystallisation Studies

• 4 x 50 ml reactors• Independent heating and cooling• Automated solvent-reagent dosing, quenches and dilutions• Independent agitator control• In-situ turbidity measurement• Raman Monitoring• pH Monitoring

CRYSTALLISATION DEVELOPMENT

Design-Expert® Software

Correlation: -0.035

Color points by

Run31

1

X1: Design ID

X2: C:Seed conc

2

2

22

2

12

34

56

78

910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

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Design-Expert® Software

conversionDesign Points98

2

X1 = B: TempX2 = C: Seed conc

Actual FactorsA: conc = 0.15D: Amount seed = 3.35

E: cooling rate = 0.17

48.00 54.00 60.00 66.00 72.000.10

0.11

0.12

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0.14

conversion

X1: B: TempX2: C: Seed conc

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95

20 85

OPTIMISATION & TECHNOLOGY TRANSFER

Robustness Studies

PROCESS UNDERSTANDING

“A system is robust if its sensitivity to changes in certain critical factors, around a setpoint, is within defined limits.”

Key Process Parameter Studies

Fate Of Impurity Studies

Screening Studies

Is the process Robust within acceptable ranges (PAR and NOR)

Process Understanding

Route Scouting

Route Development Studies

CrystallizationDevelopment

Key Process Parameter Studies

(DOE Studies)

Fate Of Impurities Studies

Technology Transfer

PROCESS UNDERSTANDING

PROCESSCHEMISTRY SERVICES

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