EQUIPMENT LIST Chemical development, non-GMP manufacture,

cGMP manufacture and analytical services

This document contains information that is confidential and proprietary and is not for distribution beyond

Almac and/or the client organisation designated on the title page.

Contact:

Almac Sciences Ltd.

Almac House

20 Seagoe Industrial Estate

Craigavon BT63 5QD

United Kingdom

T +44 28 3833 2200

E sciences@almacgroup.com

W www.almacgroup.com

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Location of sites

1. Almac Sciences LLC, Souderton, Pennsylvania, United States .......................................3

2. Almac Sciences Ltd, Craigavon, Northern Ireland, United Kingdom ................................4

3. Almac Sciences Scotland Ltd, Edinburgh, Scotland, United Kingdom ..............................9

4. Arran Chemical Company Ltd, Athlone, Ireland...................................................... 10

5. Almac Sciences Ireland Ltd, Athlone, Ireland ........................................................ 12

1

2 4

5

3

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1. Almac Sciences LLC, Souderton, Pennsylvania, United States

1.1 Analytical equipment (cGMP)

Instrument Count

Agilent 1200 HPLC system with PDA 1

Agilent 1200 HPLC system with VWD 1

Agilent 1200 HPLC system with VWD and CAD 1

Agilent 1260 HPLC system with PDA 1

Agilent 1260 HPLC system with VWD 3

Agilent 1260 HPLC system with VWD and RID 1

Agilent 1290 HPLC system with PDA 1

Waters Acquity H-Class systems with PDA (HPLC and UPLC) 1

Waters Acquity H-Class systems with VWD (HPLC and UPLC) 1

Agilent 7890A with FID and Agilent 7693 with Auto sampler, head-space (GC Chromatography)

2

Distek Evolution 6100 Dissolution Baths 5

Distek Evolution 6300 Dissolution Bath 1

Evolution 4300 Autosampler with dual pumps 3

Perkin Elmer Spectrum 100 FT-IR with ATR, DRIFT, Transmission 1

Perkin Elmer Lambda 35 UV/VIS spectrophotometer 1

Mettler C30 Coulometric Karl Fisher titrator 1

Mettler V30 Volumetric Karl Fisher titrator 1

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2. Almac Sciences Ltd, Craigavon, Northern Ireland, United Kingdom

2.1 Kilo laboratory reactors (non-GMP)

Reactors Capacity

Glass lined steel 2 x 50 L

Glass 1 x 25 L 1 x 50 L 2 x 100 L

2.2 Plant and laboratory reactors (cGMP)

Reactors Capacity

Glass lined steel -20°C to 180°C 5BarG working pressure

2 x 1000 L 1 x 630 L 2 x 250 L 1 x 100 L

Hastelloy (-20°C to 180°C) 1 x 450 L

Hastelloy (cryogenic capability: -80°C to 180°C) 1 x 150 L

Glass

3 x 30 L 2 x 20 L 2 x 10 L 1 x 5 L

2.3 Product isolation and drying (cGMP)

Equipment Capacity

Nutsche filter 1 x 60 kg 4 x 35 kg 2 x 5 kg

Centrifuge 1 x 20 kg 1 x 2 kg

Pressure filter/drier 1 x 200 kg 1 x 20 kg

Tray oven/drier

1 x 60 kg 3 x 35 kg 1 x 20 kg 2 x 5 kg

2.4 Micronisation (cGMP)

Apt Spiral Jet Mill

Ktron twin-screw feeder

4 and 8 inch mills

100 g – 150 kg capacity

Controlled environment clean room

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Built-in high containment isolator with 1 µg/m3 containment

2.5 Slurry milling (cGMP)

IKA Magic Laboratory (for process research and development)

IKA DRS 2000/10 (for cGMP production) with mill speed 7300 rpm and Flowrate 2000 kg/hr

2.6 Special handling (cGMP)

Material Capability

Hydrogenation Up to 450 L

Ozonolysis Development 10g ozone/hour (deployed at up to 20 L scale)

Production 300g ozone/hour (deployed at up to 150 L scale, cryogenic)

Photochemistry Development 400 W medium pressure mercury lamp (2 L scale)

Production 6 kW medium pressure mercury lamp (100 L scale)

Enzymatic biotransformation Up to 1,000 L

Chromatography Biotage 400 Preparative HPLC 5 cm, 8 cm and 15 cm columns

Freeze dryer 28 L

Potents Default limit for material handling: OEL 0.1 µg/m3 (lower OEL material would be subject to project specific risk assessment to determine if it can be handled)

Cytotoxics Dedicated facility and equipment, 10-30 L scale

2.7 Peptide processing (non-GMP)

Equipment Capability

Chromatography 4 x AKTA purification systems

Lyophilisation Bench top and 10 L

Ultrafiltration Minim Pall II system capable of processing up to 2 L per day

2.8 Peptide synthesis (cGMP)

Equipment Capability

2 x CS Bio 536 synthesizers 500 ml to 20 L reactors

1 x CS Bio 936 synthesizer

Chromatography Two purification skids (Novasep and Varian) 5 cm, 8 cm and 15 cm columns

Lyophilisation 8 L and 28 L

Centrifugation Rotanta 460R capable of processing 4 x 600 ml per cycle

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2.9 Analytical equipment (cGMP)

Technique Instruments Features Numbers

X-ray powder diffraction (XRPD)

Panalytical Xpert Pro MPD Pixcel detector

Reflection, transmission, variable temperature, auto-sampling

1

X-ray powder diffraction (XRPD)

PANalytical Aeris Research Edition

Reflection, transmission, variable temperature, auto-sampling

1

Differential scanning calorimetry (DSC)

Perkin Elmer Jade & Pyris 7 Sub-ambient, auto-sampling 1

Hyper DSC Perkin Elmer Diamond Sub-ambient to 350°C, up to 500K/min heat/cool rates

1

Thermogravimetric analysis (TGA)

Mettler Toledo STARe Simultaneous DSC & TGA 1

Dynamic vapour sorption (DVS)

Hiden Isochema IGAsorp Aqueous and organic vapour 1

Particle size analysis

Malvern Mastersizer 3000 Sympatec Helos

Wet and dry dispersion 2

Intrinsic dissolution

Distek Evolution 6300 Modified for small samples 1

Infrared spectroscopy (FTIR)

Thermonicolet Avatar 370 Perkin Elmer Spectrum RX1

ATR golden gate 2

Ultraviolet-visible spectroscopy (UV-vis)

Analytik Jena, Specord 200 & Hitachi U-2001

2

Nuclear magnetic resonance (NMR)

Bruker 500MHz Ultrashield Bruker 400MHz Ultrashield

1H, 13C, 19F and 31P Probes 1D and 2D experiments

2

Chromatography (HPLC)

Agilent, Waters RI, CAD, Fluorescence detectors ion and size exclusion systems large prep scale capabilities

50

Chromatography (UHPLC)

Agilent / Waters PDA and UV visible coupled with mass spectrometry

21

Chromatography (GC)

Agilent 6890 ECD, TCD and FID detectors. Headspace systems

8

Liquid Chromatography Mass Spectrometry High Resolution

Agilent 6530 LC-Q-TOF Agilent 6230 LC-TOF

LC-MSn capabilities, accurate mass

2

Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

Agilent 7900 Metals analysis 1

Liquid Chromatography Mass Spectrometry

Agilent 6460 LC-Triple Quad AB API 3000 LC-Triple Quad AB API 365 LC-Triple Quad

LC-MSn capabilities 3

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Gas Chromatography Mass Spectroscopy

Polaris Q Trace GC Agilent 7890/5975

Simultaneous FID and MS analysis, MSn capabilities

2

Ion Chromatography

Dionex ICS-3000 and ICS-5000

Conductivity and electrochemical detectors

3

Dissolution Distek USP apparatus I and II 8

Water content Mettler Toledo DL39, C30 Karl Fischer coulometry & titrometry, Stromboli oven

8

Polarimetry Perkin Elmer 341 1

Autotitrator Mettler Toledo T70 1

Stability testing All ICH zones Large humidity chambers > 300 m3 capacity

2.10 Analytical equipment (non-GMP)

Technique Instruments Features

Technique Instruments Features

Microscopy

Smiths IlluminatIR Olympus BX51 Linkam hot-stage Keyence microscope

From 10 – 200X, polarizing filters, digital image capture, ATR & ARO objectives, -196 to 350°C, linked to FTIR

Raman spectroscopy

Perkin Elmer RamanMicro 200F series Raman Microscope Avalon RamanStation Fusion R1

Microscopy and mapping capabilities

Automated solubility determination

Clarity crystallisation station

Multi well reactor block with turbidity probes

Crystallisation development

Jacketed glass reactors (100mL – 5L) Lasentec FBRM & particle video imaging (PVM) probes

On-line sampling for particle size and polymorph monitoring

Formulation development

Freeze dryer Spray dryer High shear mixing (Ultra Turrax) Rotary evaporators (Buchi) Ball mill (Retsch)

Development of stabilised amorphous formulations

Software modelling tools

ACDLabs Percepta Dynochem suite Mercury HighScore Plus

pKa, log P, solubility modelling, crystal structure visualisation, unit cell indexing

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2.11 Analytical equipment for biocatalysis support (non-GMP)

Instrument Count

Evaporative light scattering detector 1

Capillary electrophoresis 1

U-HPLC systems (capable of high throughput screening) 6

HPLC systems (capable of high throughput) 13

Gas chromatography systems 3

Fluorescent/UV plate readers 2

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3. Almac Sciences Scotland Ltd, Edinburgh, Scotland, United Kingdom

3.1 Peptide synthesis (non-GMP)

Instrument Count

ABI peptide synthesizers (single port) 5

Prelude peptide synthesizer (6 port) 1

Symphony peptide synthesizer (12 port) 1

CS Bio 536 (development scale synthesiser) 1

AKTA purification systems (capable of protein methods e.g. IEX, SEC, IMAC) 5

Gilson purification systems 4

Bench top lyophilizers 6

3.2 Analytical equipment (non-GMP)

Instrument Count

Waters Alliance HPLC (analytical) 2

Agilent 1200 HPLC 2

Waters UPLC 1

Bruker MS 1

SDS-PAGE (for protein analysis) 1

UV (for in-process analysis, detection of peptide content) 1

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4. Arran Chemical Company Ltd, Athlone, Ireland

4.1 Kilo laboratory

5 L,10 L, 20 L and 50 L glass vessels

Short path distillation

HEL parallel reactor system

4.2 Pilot plant

Reactors Capacity

Glass lined steel Pressure rated to 3 BarG

-40 to 130ºC

1 x 100 L 1 x 200 L 1 x 400 L

Hastelloy Pressure rated to 6 BarG

-40 to 130ºC 1 x 200 L

Stainless steel Pressure rated to 6 BarG

-40 to 130ºC

1 x 200 L 1 x 500 L

1 x 1000 L

4.3 Manufacturing plant reactors

Reactors Capacity

Glass lined steel Pressure rated to 3 BarG

-15 to 130ºC

1 x 2200 L 2 x 2500 L 1 x 4000 L 2 x 6000 L 1 x 8000 L

Glass lined steel Pressure rated to 3 BarG

-15 to 200ºC 1 x 2200 L 1 x 6000 L

Stainless steel Pressure rated to 6 BarG

-15 to 130ºC

4 x 4000 L 1 x 5000 L 1 x 8000 L

Stainless steel Pressure rated to 6 BarG

-15 to 200ºC 1 x 2000 L

4.4 Product isolation

Equipment Capacity

Falling film distillation <1 mbar

Up to 200ºC, 200 to 300 kg per day

Centrifugation 1.0 to 2.5 tonne

Dryers 0.5 to 0.6 tonne

Vacuum ovens 3

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4.5 Analytical equipment

Instrument Count

GC 5

HPLC 5

UPLC 1

FT-IR (ATR) 1

UV 1

Melting point apparatus (automated) 1

Karl Fischer titrator 1

Autotitrator 1

Polarimeter (electronic) 1

Refractometer 1

Microscope 1

Analytical balances 2

IR drier (loss on drying) 1

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5. Almac Sciences Ireland Ltd, Athlone, Ireland

5.1 Analytical equipment

Description

ICH stability storage

80°C and -20°C freezers

5°C refrigerated storage

25°C/60%RH long term stability storage

30°C/65%RH intermediate stability storage

40°C/75%RH accelerated stability storage

Mass spectrometry

Sciex API 3000

Sciex (X2) API 4000

Sciex API 4000 QTRAP

Chromatography

HPLC Shimadzu LC20 Prominence

HPLC Waters (X5) UV, PDA, RI and flouesence detection

HPLC Perkin Elmer (X2) Series 200

HPLC Shimadzu UFLC XR

HPLC Shimadzu UFLC

GC Agilent 7890A, 6890 (x3) with FID, ECD and NPD detection.

Agilent Headspace units (x3)

GC Hewlett Packard 6890

Spectroscopy

Perkin Elmer Wallac Victor 1420

Molecular Devices Spectramax Plus 384

FT-IR Bruker Alpha-P

UV-Vis Analytik Jena Speedcord 205

Electrophoresis

BioRad ChemiDoc MP (Comprehensive imaging system for gels and Western Blots)

BioRad TransBlot Turbo (Western Blots)

BioRad Tetra cell (SDS-PAGE, Native PAGE, 2-D PAGE, DGGE, Gel IEF)

Drug product analysis

Dissolution baths Caleva 10+ST

Disintegration bath Caleva Dist 2

Friability tester Erweka TA 120

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Particle size distribution Shimadzu SALD-2201

Malvern (ZSP Nano series) ZEN5600

Bacterial Identification system

Biolog Micro station - identification of Bacterial Isolates • Gram positive Rods • Gram Positive cocci • Gram negative rods.

Micro

QCELL260Cooler Incubator 20-25’C Memmert Incubator INE 800 30-35’C Memmert Incubator IFE 600 42-44’C Memmert Incubator INE 600 35-37’C Memmert Incubator INE 600 30-35’C Memmert Cooled Incubator IPC450 20-25’C Memmert Incubator IFE 37+/-1’C

Other technologies

Perkin Elmer 2470 Wizard2 (Gamma counter)

Perkin Elmer Filtermate (Cell harvester)

ASYS Atlantis (Microplate washer – ELISA)

CEM Technologies Mars6 (Microwave assisted digester)

Savant Speedvac SPD2010 (Vacuum centrifuge)

AA with flame and graphite furnace

Metrohm Kark Fischer

Mettler Toledo T70 Auto-Titrator

Caleva Hardness tester

Colorimeter

CEM Microwave digester Mars 6

Microscope

Refractometer

Polarimeter

Melting Point