Pharmaceutical Outsourcing Company Focus: A Russell Publishing Publication
Xcelience, LLC
5415 West Laurel Street
Tampa, Florida  33607
USA

Tel: 1-813-286-0404
Fax: 1-813-286-1105
EMail: Info@xcelience.com
Visit our website at: www.xcelience.com

COMPANY DESCRIPTION

Xcelience® is your premier source for formulation development and manufacturing solutions.

From preformulation to clinical supplies manufacturing and stability, we have one focus: the success of your project. Our state-of-the-art equipment, including the XRD, Xcelodose® 600 S, and TF-1 Blister Packaging Thermoformer, combined with our years of experience providing innovative solutions make the path from compound to clinic feel effortless.

We are more than just a service. We are formulation development and manufacturing made easy – at last.

COMPANY BACKGROUND


Consulting


Drug development consulting services include product development planning, management and review, analytical development planning and review, project management, vendor selection management, expert testimony, technical due diligence, and candidate evaluation.



FACILITIES

Xcelience operates out of two cGMP compliant, DEA licensed facilities (24,000 ft2 each) located in Tampa Bay, Florida, one of the most desirable cities in the world.

SERVICES & CAPABILITIES

Preformulation
• Salt screens
• Polymorph screens
• Drug substance

Characterization
• Excipient compatibility
• Accelerated stability
• Chiral stability

Formulation
• Solids (tablets, capsules, sustained release and coatings)
• Semi-solids (ointments, creams, gels)
• Dispersed systems (emulsions, suspensions)
• Liquids (orals, ophthalmics, parenterals)

Stability
• ICH conditions
• Protocol design
• Report generation
• Sample analysis
• Secure storage area
• SLIM, our stability laboratory information management system, meets FDA standards for 21CFR11 compliance.

Analytical
• Method development
• Qualification and validation
• Raw material testing
• Stability sample analysis
• Dissolution testing
• Residual solvent analysis
• Chiral determination
• Cleaning evaluations
• Technical packages for drug substances

Manufacturing
Clinical Manufacturing, Packaging, and Labeling capabilities include:
• API into capsule
• Tablets and capsules
• Liquid in capsule
• Semi-solids
• Non-sterile liquid

In addition, we provide reference product blinding, packaging and labeling services, and offer expertise in creation of matching placebo formulation, creation and qualification of blinded reference product, process qualification, process definition optimization, and technology transfer.