Xcelience is a premier provider of preformulation, analytical, formulation development, manufacturing, and clinical packaging solutions. They have established expertise in accelerating drug development timelines, with a focus on quality and ensuring compound success. Their expanded facilities and market-leading expertise in areas like powder-in-capsule formulations enable reduced development risks and timelines for clients.

1. Xcelience Overview
2013

2. Core Principles
We are all in the business of improving
the quality of human lives.
Each of us is joined in the commitment to
reach critical milestones faster, deliver
clinical materials on time, control costs, and
above all to ensure quality.
At Xcelience, we commit to hold ourselves to
ever-increasing high standards of quality,
service performance, and drug development
expertise that in turn enable our clients to
overcome drug development challenges and
improve chances for compound success.
We are early drug development made easy
– at last.

3. Xcelience is a premier provider of preformulation,
analytical, formulation development, manufacturing and
clinical packaging solutions with an established reputation
for accelerating project timelines.
2012 Regulatory Recognition Top 10 CMO in 2012

4. Company History
1997 2006 2008 2010 2012
Grace Street
Established Xcelience CEO Finalist for E&Y 2008 CEO Cancer
Expansion
as Tricon Formed Entrepreneur of the Year Gold Standard
Completed for
by MBO Accreditation
Tampa Chamber of Expanded Clinical
Commerce Small Business Supplies
Award Finalist
Purchased Tampa Chamber of
Acquired by 4 Phase
Grace Street Commerce Small
Top 6 Global Facility
for Business Award
CRO Expansion
Expansion Finalist (2nd Year)
1998 2007 2009 2011

5. Convenient Location
cGMP Compliant Tampa, Florida Location
• Laurel Facility (24,000 ft2)
• Grace Facility (24,000 ft2)
FDA Inspected
• 2008, December (PAI)
• 2006, June (General Systems)
• 2003, August (General Systems)
DEA Schedule License
• I to V Analytical–DEA Inspected 2012, January
• II to V Manufacturing–DEA Inspected 2010, January
• I to V Analytical–DEA Inspected 2009, December
Florida Dept. of Health Audit
• State of Florida Inspected 2010, September
European Union Requirements
• Multiple Qualified Person (QP) Audits

6. Core Competencies
 Preformulation Services
> Polymorph Screening, Salt Selection,
Drug Product Characterization
 Analytical Services
> Method Development and Validation,
Waters and Agilent Instrumentation
 Formulation Development
> Solids, Semi-solids, Oral Liquids
 Manufacturing, Packaging and Labeling
> Solids, Semi-solids, Oral Liquids
> Direct Fill API into Capsules
> Matching placebo formulation
> Blinded reference product
> Bottling or Blister Packaging
 Stability Program Management
Broad variety of temperature and humidity
conditions

7. Preformulation Services
Solid and Solution Characterization
Drug substance characterization can be conducted using the
following equipment (tests):
– Thermal evaluation (DSC, TGA and/or Hot Stage)
– Particle Size
– FTIR
– XRD
– Morphology analysis (polarized microscope)
– pKa determination (calculated or experimental)
– log P / log D determination
– Moisture content (Karl Fischer)
– Moisture sorption profile (VSA)
– pH solubility profiles
– Solubility studies (visual, HPLC and/or UV)

8. Analytical Services
 Method Development,
Qualification, and Validation
 Technical Packages for Drug
Substances
 HPLC/Dissolution Testing
 Residual Solvent Analysis
 Raw Material Testing
 Stability Sample Analysis
 Chiral Determination
 Cleaning Evaluations
 Stability Program Mgmt and
Sample Analysis

9. Analytical Instrumentation
• Equipment
– HPLC: 30 instruments, Waters and Agilent
– UPLC: 2
– GC w/ Headspace
– Dissolution Stations w/ autosamplers: 9 instruments,
Vankel and Distek
(apparatus 1 & 2 - bath and bathless)
– UV/Vis
– FTIR
– Karl Fischer: Coulometric and Volumetric
– Brookfield Viscometer

10. Formulation Services
 Solids
> Tablets, capsules, sustained release, coatings
 Semi-Solids
> Ointments, creams/emulsions, gels
 Dispersed Systems
> SEDDS/SMEDDS, suspensions
 Liquids
> Orals
> Parenterals (tox only)

11. Formulation Development for
Poorly Soluble Compounds
Conventional Formulations/Processes Alternate Processing
 Use water soluble excipients  Add drug to aqueous granulating
 Micronize the API solution containing wetting/solubilizing
agent
 pH modifiers
 Dissolve API in hydroalcoholic/
> citric acid, succinic acid etc
alcoholic granulating solution
 Solubilizing/wetting agents
> May alter API characteristics
> sodium laurel sulfate, Tween 80
 Form Solid dispersion/solution in hot
melt process using CFS1200™
 Complexing agents (Cyclodextrins)
 Liquid fill hard gelatin capsule

12. Manufacturing
 Manufacturing  Additional Expertise
> Tablets and capsules > Creation of matching placebo
• Sustained release formulation
• Coatings > Creation and qualification of
> API in a capsule blinded reference product
> Liquids in a capsule > Process qualification
• Suspensions > Technology transfer
• Emulsions > Process definition optimization
> Semi-solids
> Non-sterile liquid
 Reference Product Blinding
 Packaging and Labeling

13. Partnering Advantage
Partnering with Xcelience can reduce
product risk and accelerate timelines for
early phase drug development
API in Capsule Week
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
API Characterization 1 2 3 4 5 6 7 8 9 10 11 12
Analytical - API Method Evaluation / Dev 1 1 2 3 4 5 6 7 8
Analytical - DP Evaluation / Method Dev 1 2 3 4 5 6 7 8
Feasibility Study - Capsule Compatibility 1 2 3 4
Create and Approve GMP Batch Records 1 13 Weeks
Manufacture GMP Batches 1 2
Release Testing of GMP Material 1 2
Initiate ICH Stability Study 1
Traditional Formulation Week
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29
API Characterization 1 2 3 4 5 6 7 8 9 10 11 12
Exipient Compatibility 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Formulation Development / Selection 1 2 3 4 5 6 7 8
Analytical - DP Evaluation / Method Dev 1 2 3 4 5 6 7 8
Prototype Stability 1 2 3 4 5 6 7 8 9 10 11 12
Create /Approve GMP Batch Records 1
Manufacture of GMP Batches 1 2
Release Testing of GMP Material 1 2
Initiate ICH Stability Study 1
Week
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
Accelerate Timelines. Conserve API. Minimize Downstream Problems.
API Characterization 1 2 3 4 5 6 7 8 9 10 11 12
Excipient Compatibility 1 2 3 4 5 6 7 8 9 10 11 12 13 14
DevDevelopment 1 2 3 4 5 6
Formulation Development / Selection 1 2 3 4 5 6 7 8
Analytical - DP Eval./ Method Dev 1 2 3 4 5 6 7 8
Prototype Stability 1 2 3 4 5 6 7 8 9 10 11 12

14. Market Leadership
Powder-in-Capsule
> Faster time to FIH studies
> Market leading experience
 > 100 APIs, >130 batches
> Defined programs, proven results
 API into capsule projects are on average
completed 45% faster than traditional
formulation development efforts, shave
13-17 weeks from total development time
> Greater global capacity
 Three dedicated Xcelodose® systems
 3 NA, 1 EU
 Xcelodose® systems in the experimental
area enable clients to use laboratory
grade material for dispensing head
selection, filling process evaluation,
capsule compatibility, or to fill powder into
capsule (PIC) for preclinical studies.

15. Stability
• ICH conditions
• Protocol design
• Report generation
• Stability software management system
• Sample analysis
• Secure storage area

16. Enhanced Expertise,
Improved Production Times
 Expanded Roller Compaction Capabilities
> Micromeritics AccuPyc II 1340 Gas Pycnometer
> Micromeritics GeoPyc 1360 Envelope and T.A.P. Density Analyzer
 Expanded Encapsulation Capabilities
> MG Futura – capsule filling for powder and pellets
> LCI multi-granulator MG-55 (extruder)
> QJ-230T marumerizer (spheronizer)
> Wurster insert (bottom spray) for Glatt GPCG-3 fluid bed processor
 New Fully-Automated Packaging Line (including ink-jet coding)
> For primary bottling of tablets and capsules

17. Clinical Packaging Services
 Primary packaging
 Filling of API into bottles (AIB)
 Filling of API into capsules (AIC)
 Powder filling into sachet/pouch
 Blister packaging including cold form aluminum blisters
 Card/wallet sealing
 Bottle packaging
 Labeling and assembly services
 Multi-language booklet labeling
 Open label / double blind labeling, disclosure envelopes
 Randomization services
 Patient kit assembly
 Warehousing and distribution
 cGMP warehousing of clinical supplies
 Storage and handling of schedule II-V products
 Global site distribution and tracking
 Package engineering and design
 Tooling, card/wallet (CR) and patient kits
 Global procurement of comparator medications
 Supported with product pedigree documents

18. Four Phase Facility Expansion
Phase 1: Laurel Expansion – Complete
> Expands formulation development capacity, Increases speed
Phase 2: Laurel Expansion – Complete
> Expands analytical and formulation development capacity,
Increases speed
> Expands manufacturing and packaging capabilities
Phase 3: Laurel Expansion – Complete
> Renovation and expansion of the existing cGMP
manufacturing/packaging area
Phase 4: Grace Facility Expansion – Complete
> Purpose-built expansion of new primary and secondary clinical
packaging facility

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21. Unique Advantage
Market Leading Performance Sound
Expertise Culture Management
Recognized formulation Scheduling flexibility, Conservative financial
development expertise FTE programs management
Proven expertise with Disciplined project Diversified client mix
low dose formulations management
Minimal employee
Streamlined equipment No double-booking, turnover, retained
from experimental to 99% on-time completion project knowledge
GMP record
Ability to attract and
API sparing strategies Quality systems ensure retain top talent
minimize waste safe handling of
cytotoxic / potent
compounds

22. Choose Xcelience
Quality-First Focus. Expertise. Flexibility.
Partnership

23. Thank you!
For more information please contact:
Sharon Burgess
Email: sharon.burgess@xcelience.com
Phone: 603-226-4060
Cell: 603-731-3691
Fax: 603-415-3330