We are all in the business of improving the quality of human lives.

Each of us, whether client or service provider, are 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 call this Molecular Responsibility™, the commitment 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.

Partnering with a specialist like Xcelience for early phase development can significantly reduce product risk and accelerate drug development timelines.

We are early drug development made easy – at last.

Core Competencies

API Characterization> Polymorph Screening, Salt Screening, Drug Product Characterization

Analytical Services> Method Development and Validation, Waters and Agilent Instrumentation

Dosage Form Development and Manufacturing> Solids, Semi-solids, Liquids

Manufacturing, Packaging and Labeling> Direct Fill API into Capsules> Matching placebo formulation> Creation and qualification of blinded reference product> Process qualification> Technology transfer> Process optimization > Blister Packaging

Stability Program Management> Broad variety of temperature and humidity conditions

Unique Advantage

Xcelience is the market leader of powder into capsule (PIC) services. Achieves speed to FIH studies by enabling clients to fill very small amounts of

API directly into capsules without compromising quality, cost or precious API. We have more experience than any other provider

> 100 APIs, >130 batches Defined programs deliver proven results.

API into capsule projects are on average completed 45% faster than traditional formulation development efforts, and in some cases have enabled our clients to shave from 13 to as much as 17 weeks from total development time.

We have greater capacity than any other service provider. Three dedicated Xcelodose® systems; two in the GMP area, and the

third in the experimental area. The Xcelodose® in the experimental area enables clients to use

laboratory grade material for dispensing head selection, filling process evaluation, capsule compatibility, or to fill powder-in-bottle (PIB) or powder into capsule (PIC) for preclinical studies.

Xcelience is committed to adding innovation only where it makes sense to meet the needs of our clients.

> Liquid in capsule services enable pharmaceutical companies to exploit the potential of lipid-based formulations to overcome poor aqueous solubility and improve compound bioavailability.

> Small scale batch production for companies facing the challenge of limited API.

> Physicochemical tests conducted during prenomination and lead optimization using our XRD instrumentation enable rational decisions for compound understanding, salt selection or polymorph identification that maximize the probability of compound success and are essential for establishing a sound intellectual property position.

Xcelience can provide comparator product blinding for clients that need to blind products for clinical trials or comparator studies.

Xcelience is licensed to work with controlled substances.

Service Overview

Preformulation Services

Solid Characterization

Drug Substance Characterization> Thermal information> X-ray Powder Diffraction> Particle size> Moisture Content> Morphology

Salt Selection screening Polymorph screening Purity determinations Solid-state stability Photostability Intrinsic Dissolution Reference Standard Qualifications

Solution Characterization Drug substance evaluation pKa determination Partition and distribution coefficient pH Solubility profile

Other Services Excipient compatibility Accelerated stability (ICH conditions) Chiral Stability

Analytical Services

Method Development, Qualification, and Validation Raw Material Testing (Selected) Stability Sample Analysis Dissolution Testing Residual Solvent Analysis Chiral Determination Cleaning Evaluations Technical Packages for Drug Substances

Formulation Development

Solids> Tablets, capsules, sustained release, coatings

Semi-Solids> Ointments, creams, gel

Dispersed Systems> Emulsions, suspensions

Liquids> Orals, ophthalmic, parenterals

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> API in a capsule> Liquids in a capsule

• Suspensions• Emulsions

> Semi-solids> Non-sterile liquid

Reference Product Blinding Packaging and Labeling

Expertise> Creation of matching placebo

formulation> Creation and qualification of

blinded reference product> Process qualification> Technology transfer> Process definition optimization

Clinical Packaging Services

Package engineering and design Tooling, card/wallet (CR) and patient kits

Global procurement of comparator medications Supported with product pedigree documents

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

Stability Programs

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

Convenient Location

Tampa, Florida Location> Laurel Facility (24,000 ft2)

cGMP Compliant

FDA Inspected> 2008, December (PAI)> 2006, June (General Systems)> 2003, August (General Systems)

DEA Schedule License> 2007, October> II to V Manufacturing> I to V Analytical

Why Xcelience?

Quality-First Focus> Three FDA audits (2008, 2006, 2003) with the last being a PAI> Numerous client audits/year reinforce compliance with latest regulations> Low staff turnover

Speed> Accelerated drug development programs to meet critical milestones> Strong on-time project completion record

Agility> Cross-training program for pharmaceutical development staff> Flexible manufacturing model, dedicated equipment

Technology> Market leadership for Powder-in-Capsule programs with Xcelodose® precision powder micro-dosing

systems> Expanded process technology capabilities designed to deliver improved manufacturing outcomes in

a manner consistent with QbD > Cutting edge preformulation technology including the XRD for polymorph screens, salt screens, and

crystallinity determination> Blister packaging with tooling design for a wide variety of dosage forms

Expertise> Ability to attract top talent with successful drug development track records> More Xcelodose™ experience than any other CRO, >100 APIs, >130 batches

Partnership> Unique project team structure feel likes an extension of client facility> Leveraging size to our advantage to provide personal attention

Choose Xcelience

Quality-First Focus. Expertise. Flexibility.Partnership