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
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
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
