Kuecept Ltd was founded in 2007 by a group of experienced industrial scientists to provide customised R&D solutions and consultancy services to the pharmaceutical, biotech and health-care industries. Today, we are one of a few contract research organisations dedicated solely to providing preformulation, formulation development and enabling drug delivery services to companies in the discovery / preclinical stages. By working exclusively in this field, we have developed a wealth of knowledge and expertise of enabling drug delivery technologies and formulation know-how in drug solubility and bioavailability enhancement and with over 600 projects completed to date on over 250 NCEs, are well placed to help resolve some of the most complex drug development issues. Our experience covers a broad range of discovery, development & related activities supporting oral, parenteral and orally / nasally inhaled drug products.

1. Specialist Preclinical Formulation
&
Drug Delivery Services

2. Who Are We?
• A specialist contract research organisation offering bespoke preclinical and
early-stage formulation and drug-product development services to the
pharma, biotech and healthcare industries
• Core expertise in applying formulation strategies to enhance API solubility
/ bioavailability and control / modulate drug release in preclinical models
• Expertise in oral, parenteral and pulmonary dosage form development
and routes of administration
2

3. History
• Founded in June 2007 as a consultancy-based organisation supporting start-up
and virtual organisations
• Initially offering study design, data review and outsourced project
management
• Opened new R&D facility in 2009 in Potters Bar, UK (ex Generics UK labs)
• Operate an organic growth model
• Remain 100% privately owned (client focussed, not shareholder driven)
• Small business, global reach.
• Worked with over 75 organisations worldwide on over 600 research
programs and > 250 NCEs
• Strong client partnerships (>90% repeat business) 3

4. Where Can We Support You?
Preformulation
testing
Dose vehicle
screening for first-time-
in-animal PK
testing
Formulation
development and
optimisation for
preclinical safety
assessment
Enabling technology
screening for
bioavailability
enhancement and
controlled release
Technology transfer
for cGMP
manufacture and
clinical trials supply

5. 01. Preformulation
A COMPREHENSIVE PREFORMULATION STUDY HELPS IN UNDERSTANDING THE PHYSICO-CHEMICAL
PROPERTIES OF THE DRUG MOLECULE AND PROVIDES THE FOUNDATION FOR
DEVELOPMENT OF A ROBUST AND STABLE PRECLINICAL DOSAGE FORM
5
• pKa / ionisation constant determination
• Partition coefficient and distribution coefficient as a
function of pH
• pH-solubility profiling
• Solubility / stability in biorelavant fluids (SGF,
FaSSIF/FeSSIF, FaSSCoF, SLF, blood plasma)
• Full physicochemical properties testing
• Salt formation / polymorph screening
• Excipient compatibility studies
• Accelerated stability studies with controlled storage at
25º C/60% RH, 30º C/65% RH 40º C/75% RH, 60º C
• Dissolution studies

6. 02. Preclinical Formulations
AT THIS STAGE OF DEVELOPMENT, THE AIM IS TO IDENTIFY A STABLE AND SAFE DOSE VEHICLE
TO ENABLE MEANINGFUL EFFICACY AND TOXICITY ASSESSMENT BY MAXIMIZING EXPOSURE
UPON ADMINISTRATION
6
• CO-SOLVENT SYSTEMS
• INCLUSION COMPLEXATION (CYCLODEXTRINS ETC)
• LIPID-BASED SELF-EMULSIFYING SYSTEMS (SEDDS /
SMEDDS)
• PARTICLE SIZE REDUCTION (MICRONISED AND
NANOPARTICULATE SUSPENSIONS)
• PH ADJUSTMENT / SALT FORMATION
• AMORPHOUS SOLID DISPERSIONS
• EMULSIONS / MICELLAR SOLUBILISATION
✓ ✓
✓ ✓
✓
✓
✓ ✓
✓
✓ ✓

7. 03. Enabling Technologies
EFFECTIVE TECHNOLOGY SELECTION FOR IMPROVING BIOAVAILABILITY (BA) CAN ACCELERATE
THE DEVELOPMENT OF PROMISING COMPOUNDS AND REDUCE THE OVERALL COST AND
COMPLEXITY OF DRUG DEVELOPMENT
7
Our capabilities for preparation of solubilised intermediates include:
• Spray-dried dispersions (SDDs)
• Hot-melt extrusion (HME)
• Matrix microspheres (controlled and sustained release)
• Aqueous and organic nano-suspensions by wet-bead milling
• Solid nano-crystalline dispersions (SNCDs)
• API Micronisation (wet and dry)
• Amorphous multi-particulates (immediate and controlled release)
• Solubilised liquids (including emulsions/ micro-emulsions,
complexation (e.g. cyclodextrins), lipids and oily dispersions,
liposomes, co-solvents)
• Lyophilisation

8. 8
03. Enabling Technologies
Technology Instrumentation Oral Parenteral Pulmonary
Nanoparticles
(aqueous and organic suspensions
and redispersable powders)
• Fritsch Pulverisette 6
• NETZSCH Laboratory Mill MiniCer
• Lena V15
• Lena V500 and V1000 (R&D and GMP rigs)
✓ ✓ ✓
Spray drying • Buchi B290 (aqueous solutions)
• Procept 4M8Trix (organic solutions)
✓ ✓
Liquids/ emulsions /
suspensions
• ESCO-Labor (high shear mixing with
vacuum/temp control)
• Silverson (LM2 and LM4 series)
• Heidolph mixers (low shear)
✓ ✓
Micronisation • Food Pharma Systems Labomill
• Food Pharma Systems Pilotmill
• Fritsch Pulverisette 6
✓ ✓
Hot-melt extrusion Thermo Scientific HAAKE MiniCTW ✓
Powder blending and
Turbular mixer
✓
manufacture of pellets /
Caleva multilab
granules
GEA Pharma Systems - Aeromatic-Fielder
Lyophilisation Thermo Scientific MicroModulyo ✓ ✓
Tableting (inc minitablets) GTP 1 Gamlen Tablet Press ✓
Capsule / tablet/ pellet
Caleva mini-coater
✓
enteric coating
GEA Pharma Systems - Aeromatic-Fielder

9. Drug Delivery Technologies
• Kuecept has developed and in-licensed
a portfolio of enabling
technologies to improve
bioavailability of poorly
soluble / permeable drugs or
modulate drug-release for
improved gastro-intestinal
targeting
9
I
High Solubility
High Permeability
III
High Solubility
Low Permeability
II
Low Solubility
High Permeability
IV
Low Solubility
Low Permeability
1 10 100 250 1,000 10,0000 100,000
Volume (mL) required to dissolve the highest dose
Permeability (1 x 10-6 cm per s)
100
10
1
0.1

10. Drug Delivery Technologies
10
ProRelease™
• Route: Oral
• Benefits: Microencapsulation technology which
can be applied to enhance drug solubility /
dissolution, modulate release kinetics (targetted
and sustained release applications), reduce PK
variability through improved transit performance
and provide taste masking benefits
• Dosage forms: Tablets, capsules, suspensions
• Patent status: Granted (EU, JP and US)

11. Drug Delivery Technologies
11
Lena Nano™
• Route: Oral and parenteral
• Benefits: Wet-milling technology for rapid
production of fine suspensions and nano-suspensions
in both aqueous and non aqueous
liquids. Suitable for difficult to micronise drugs,
e.g. abrasive or ductile
• Dosage forms: Tablets, capsules, suspensions,
creams
• Patent status: Granted (Worldwide)

12. Drug Delivery Technologies
12
DuoCoat™
• Route: Oral
• Benefits: Novel enteric coating technology that
can be applied to a wide range of conventional
oral dosage formulations to speed up drug
release and reduce PK variability. Ideal for drugs
which have a narrow absorption window in
proximal small intestine or require precise gastro-intestinal
targeting (e.g. ileo-colonic delivery).
• Dosage forms: Tablets, capsules, pellets / granules
• Patent status: Granted (worldwide)

13. Drug Delivery Technologies
13
Combisphere™ & MicronEase ™
• Route: Pulmonary
• Benefits: Highly respirable crystalline drug
combination particles allowing co-deposition of
single agents or multiple active ingredients in the
alveolar airways
• Dosage forms: DPI, pMDI and nebulisation
• Patent status: Pending (worldwide)

14. Continuous Innovation
14
• BBSRC award to investigate use of pH responsive microspheres for oral targeted
delivery of peptides / proteins
• KESS award in partnership with Institute of Life Sciences (Swansea) to fund a PhD
to investigate use of gastro-intestinal targeting systems to improve delivery of
steroidal hormones
• Technology Strategy Board and Bio-Medical Catalyst grants to develop oral
formulations of a novel Transcription Factor Decoy oligonucleotides (ProCarta
BioSystems) for treatment of C.difficile
• Framework-7 Program: Nanotherapeutics for Antibiotic Resistant Emerging
Bacterial pathogens (NAREB)- improve the therapy of multi-drug resistant (MDR)
tuberculosis (TB) and MRSA infections

15. Working With Us
• Dedicated project manager from quote proposal to final delivery of results and report
• Frequent communication
• Communication plan defined prior to commencement of project
• On-line data access to BaseCamp project management portal
• Flexible approach.
15

16. Contact Information
Kuecept Ltd
Research & Innovation Centre
16-17 Station Close
Potters Bar
Hertfordshire EN6 1TL
England, UK
Tel: 00 44 (0) 845 084 0553
Fax: 00 44 (0) 844 443 5344
Website: www.kuecept.com
Dr Mark Saunders
Development Director
Tel: +44 (0) 7813 680602
E-mail: msaunders@kuecept.com
Dr Alastair Paton
Business Development Manager
Tel: +44 (0) 7867 523340
E-mail: apaton@kuecept.com
Dr Cristina Freire
Formulation Director
Tel: +44 (0) 7585 334775
E-mail: cfreire@kuecept.com
16