xcelience formulation development
DESCRIPTION
Partnering with a specialist like Xcelience for early phase small molecule development can accelerate timelines and reduce product risk.TRANSCRIPT
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Small Molecule Development
Pharmaceutical Development Services
Clinical Trial Manufacturing & Packaging
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Fierce Ranks Xcelience #2 in 2011
Thanks FiercePharma Manufacturing and Nice Insight!
#2 Standout CMO - Xcelience
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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
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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
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Formulation Development Options to the Clinic
API in Bottle
Powder in Bottle
API into Capsule
Formulated Tablet / Capsule
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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
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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
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Formulation Development
Solids> Tablets, capsules, sustained release, coatings
Semi-Solids> Ointments, creams, gel
Dispersed Systems> Emulsions, suspensions
Liquids> Orals, ophthalmic, parenterals
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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
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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
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Clinical Supplies Expertise
Creation of matching placebo formulation
Creation / qualification of blinded reference product
Process qualification
Technology transfer
Process definition optimization
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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
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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
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Liquid-in-Capsule
Exploit the potential of lipid-based formulations
Overcome poor solubility
Improve compound bioavailability
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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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