Small Molecule Development

Pharmaceutical Development Services

Clinical Trial Manufacturing & Packaging

Fierce Ranks Xcelience #2 in 2011

Thanks FiercePharma Manufacturing and Nice Insight!

#2 Standout CMO - Xcelience

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

3 Stage Facility Expansion

Company History

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 • 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

Quality History

Formulation Development Options to the Clinic

API in Bottle

Powder in Bottle

API into Capsule

Formulated Tablet / Capsule

API Characterization • Thermal evaluation (DSC, TGA and/or Hot Stage)• Particle Size • FTIR• XRD• Morphology analysis (polarized microscope)• pKa determination• log P / log D determination• Moisture content (Karl Fischer)• Moisture sorption profile (VSA)• pH solubility profiles• Solubility studies (visual, HPLC and/or UV)

Preformulation

Analytical Services

Method Development, Qualification, Validation

Technical Packages for Drug Substances

Residual Solvent Analysis Raw Material Testing Dissolution Testing Chiral Determination Cleaning Evaluations Stability Program Mgmt and

Sample Analysis

Formulation Development

Solids> Tablets, capsules, sustained release, coatings

Semi-Solids> Ointments, creams, gel

Dispersed Systems> Emulsions, suspensions

Liquids> Orals, ophthalmic, parenterals

Pharma 1 2 3(a) 3(b) 4

OEL(µg/M3) >1,000 100 – 1,000 10 – 100 1-10 <1

SafeBridge I II III IV

OEL(µg/M3) >500 500-10 10-0.03 <0.03

Xcelience may handle Pharma 3b and SafeBridge III compounds (30 ng/m3)

Potent Compounds,Low Dose Formulations

Roughly 1/3 of Xcelience projects involve potent compounds

Clinical Trial Supplies Manufacturing

GMP Manufacturing• Tablets, Capsules, Sustained

Release, Coatings• API into Capsule• Liquid in Capsule• Semi-solids• Non-sterile liquid

Reference Product Blinding

Packaging and Labeling

Clinical Supplies Expertise

Creation of matching placebo formulation

Creation / qualification of blinded reference product

Process qualification

Technology transfer

Process definition optimization

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

Market Leading Expertise

Speed to FIH Studies

Market Leading Expertise

Flexible Options for Experimental Studies

Global Capacity

Accelerate Drug Development Without Sacrificing Quality, Cost or Precious API

Xcelodose® is a precision powder micro-dosing system produced by Capsugel

Liquid-in-Capsule

Exploit the potential of lipid-based formulations

Overcome poor solubility

Improve compound bioavailability

Client Needs Drive Expansion

2011 Phase 1 Expansion – Complete> Expands formulation development capacity, Increases

speed

2011 Phase 2 Expansion – Near Completion> Expands analytical and formulation development capacity,

Increases speed> Expands manufacturing and packaging capabilities

2012 Grace Facility Expansion – Planned> Purpose-built expansion underway

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