Xcelience, established in 1997 and recognized as a leading pharmaceutical development service provider, specializes in small molecule development, clinical trial manufacturing, and packaging. The company has undergone significant expansions and facility upgrades to enhance its capacity and speed in formulation development and clinical supply manufacturing. Xcelience's expertise includes handling potent compounds, advanced analytical services, and innovative drug delivery solutions, positioning the company as a key player in accelerating drug development processes.

1. Small Molecule Development Pharmaceutical Development Services Clinical Trial Manufacturing & Packaging

2. Fierce Ranks Xcelience #2 in 2011 Thanks FiercePharma Manufacturing and Nice Insight! #2 Standout CMO - Xcelience

3. Company History 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 (2 nd Year) 2010 CEO Cancer Gold Standard Accreditation 2011 3 Stage Facility Expansion

4. Quality History cGMP Compliant Tampa, Florida Location Laurel Facility (24,000 ft 2 ) & Grace Facility (24,000 ft 2 ) 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

5. Formulation Development Options to the Clinic API in Bottle Powder in Bottle API into Capsule Formulated Tablet / Capsule

6. 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

7. 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

8. Formulation Development Solids Tablets, capsules, sustained release, coatings Semi-Solids Ointments, creams, gel Dispersed Systems Emulsions, suspensions Liquids Orals, ophthalmic, parenterals

9. Potent Compounds, Low Dose Formulations Xcelience may handle Pharma 3b and SafeBridge III compounds (30 ng/m 3 ) Roughly 1/3 of Xcelience projects involve potent compounds Pharma 1 2 3(a) 3(b) 4 OEL(µg/M 3 ) >1,000 100 – 1,000 10 – 100 1-10 <1 SafeBridge I II III IV OEL(µg/M 3 ) >500 500-10 10-0.03 <0.03

10. 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

11. Clinical Supplies Expertise Creation of matching placebo formulation Creation / qualification of blinded reference product Process qualification Technology transfer Process definition optimization

12. 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

13. 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

14. Liquid-in-Capsule Exploit the potential of lipid-based formulations Overcome poor solubility Improve compound bioavailability

15. 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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