Xcelience Overview 2013
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.
Core Principles
Xcelience is a premier provider of preformulation, analytical, formulation development, manufacturing and
clinical packaging solutions with an established reputation for accelerating project timelines.
Top 10 CMO in 20122012 Regulatory Recognition
1997
Established as Tricon
1998
Acquired by Top 6 Global CRO
2008
CEO Finalist for E&Y 2008 Entrepreneur of the Year
Tampa Chamber of Commerce Small Business Award Finalist
2006
Xcelience Formed by MBO
2007
Purchased Grace Street for Expansion
2009
Tampa Chamber of Commerce Small Business Award Finalist (2nd Year)
2010
CEO Cancer Gold Standard Accreditation
2011
4 Phase Facility Expansion
Company History
2012
Grace Street Expansion Completed for Expanded Clinical Supplies
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
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
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)
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
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
Formulation Services
Solids> Tablets, capsules, sustained release, coatings
Semi-Solids> Ointments, creams/emulsions, gels
Dispersed Systems> SEDDS/SMEDDS, suspensions
Liquids> Orals> Parenterals (tox only)
Formulation Development for Poorly Soluble Compounds
Conventional Formulations/Processes
Use water soluble excipients Micronize the API pH modifiers
> citric acid, succinic acid etc Solubilizing/wetting agents
> sodium laurel sulfate, Tween 80
Alternate Processing
Add drug to aqueous granulating solution containing wetting/solubilizing agent
Dissolve API in hydroalcoholic/ alcoholic granulating solution
> May alter API characteristics
Form Solid dispersion/solution in hot melt process using CFS1200™
Complexing agents (Cyclodextrins)
Liquid fill hard gelatin capsule
Manufacturing
Manufacturing
> Tablets and capsules• Sustained release• Coatings
> API in a capsule
> Liquids in a capsule• Suspensions• Emulsions
> Semi-solids
> Non-sterile liquid
Reference Product Blinding
Packaging and Labeling
Additional Expertise> Creation of matching placebo
formulation
> Creation and qualification of
blinded reference product
> Process qualification
> Technology transfer
> Process definition optimization
Partnering Advantage
Partnering with Xcelience can reduce product risk and accelerate timelines for
early phase drug development
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16API Characterization 1 2 3 4 5 6 7 8 9 10 11 12Analytical - API Method Evaluation / Dev 1 1 2 3 4 5 6 7 8Analytical - DP Evaluation / Method Dev 1 2 3 4 5 6 7 8Feasibility Study - Capsule Compatibility 1 2 3 4Create and Approve GMP Batch Records 1Manufacture GMP Batches 1 2Release Testing of GMP Material 1 2Initiate ICH Stability Study 1
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 29API Characterization 1 2 3 4 5 6 7 8 9 10 11 12Exipient Compatibility 1 2 3 4 5 6 7 8 9 10 11 12 13 14Formulation Development / Selection 1 2 3 4 5 6 7 8Analytical - DP Evaluation / Method Dev 1 2 3 4 5 6 7 8Prototype Stability 1 2 3 4 5 6 7 8 9 10 11 12Create /Approve GMP Batch Records 1Manufacture of GMP Batches 1 2Release Testing of GMP Material 1 2Initiate ICH Stability Study 1
Week
Week
API in Capsule
Traditional Formulation
13 Weeks
Accelerate Timelines. Conserve API. Minimize Downstream Problems.
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.
Stability
• ICH conditions
• Protocol design
• Report generation
• Stability software management system
• Sample analysis
• Secure storage area
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
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
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
Download Scientific Content
Scan the QR code, or visit www.xceliencexpertise.com to access free scientific content
Unique Advantage
Market Leading Expertise
Performance Culture
Sound Management
Recognized formulation development expertise
Proven expertise with low dose formulations
Streamlined equipment from experimental to GMP
API sparing strategies minimize waste
Scheduling flexibility, FTE programs
Disciplined project management
No double-booking, 99% on-time completion record
Quality systems ensure safe handling of cytotoxic / potent compounds
Conservative financial management
Diversified client mix
Minimal employee turnover, retained project knowledge
Ability to attract and retain top talent
Choose Xcelience
Quality-First Focus. Expertise. Flexibility.
Partnership
Thank you!
For more information please contact:
Sharon BurgessEmail: [email protected]: 603-226-4060Cell: 603-731-3691Fax: 603-415-3330