Xcelience Formulation Development


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

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Xcelience Formulation Development

  1. 1. Small Molecule Development Pharmaceutical Development Services Clinical Trial Manufacturing & Packaging
  2. 2. Fierce Ranks Xcelience #2 in 2011 Thanks FiercePharma Manufacturing and Nice Insight! #2 Standout CMO - Xcelience
  3. 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. 4. Quality History <ul><li>cGMP Compliant Tampa, Florida Location </li></ul><ul><ul><li>Laurel Facility (24,000 ft 2 ) & Grace Facility (24,000 ft 2 ) </li></ul></ul><ul><li>FDA Inspected </li></ul><ul><ul><li>2008, December (PAI) </li></ul></ul><ul><ul><li>2006, June (General Systems) </li></ul></ul><ul><ul><li>2003, August (General Systems) </li></ul></ul><ul><li>DEA Schedule License </li></ul><ul><ul><li>II to V Manufacturing – DEA Inspected 2010, January </li></ul></ul><ul><ul><li>I to V Analytical – DEA Inspected 2009, December </li></ul></ul><ul><li>Florida Dept. of Health Audit </li></ul><ul><ul><li>State of Florida Inspected 2010, September </li></ul></ul><ul><li>European Union Requirements </li></ul><ul><ul><li>Multiple Qualified Person (QP) Audits </li></ul></ul>
  5. 5. Formulation Development Options to the Clinic <ul><li>API in Bottle </li></ul><ul><li>Powder in Bottle </li></ul><ul><li>API into Capsule </li></ul><ul><li>Formulated Tablet / Capsule </li></ul>
  6. 6. <ul><li>API Characterization </li></ul><ul><ul><li>Thermal evaluation (DSC, TGA and/or Hot Stage) </li></ul></ul><ul><ul><li>Particle Size </li></ul></ul><ul><ul><li>FTIR </li></ul></ul><ul><ul><li>XRD </li></ul></ul><ul><ul><li>Morphology analysis (polarized microscope) </li></ul></ul><ul><ul><li>pKa determination </li></ul></ul><ul><ul><li>log P / log D determination </li></ul></ul><ul><ul><li>Moisture content (Karl Fischer) </li></ul></ul><ul><ul><li>Moisture sorption profile (VSA) </li></ul></ul><ul><ul><li>pH solubility profiles </li></ul></ul><ul><ul><li>Solubility studies (visual, HPLC and/or UV) </li></ul></ul>Preformulation
  7. 7. Analytical Services <ul><li>Method Development, Qualification, Validation </li></ul><ul><li>Technical Packages for Drug Substances </li></ul><ul><li>Residual Solvent Analysis </li></ul><ul><li>Raw Material Testing </li></ul><ul><li>Dissolution Testing </li></ul><ul><li>Chiral Determination </li></ul><ul><li>Cleaning Evaluations </li></ul><ul><li>Stability Program Mgmt and Sample Analysis </li></ul>
  8. 8. Formulation Development <ul><li>Solids </li></ul><ul><ul><li>Tablets, capsules, sustained release, coatings </li></ul></ul><ul><li>Semi-Solids </li></ul><ul><ul><li>Ointments, creams, gel </li></ul></ul><ul><li>Dispersed Systems </li></ul><ul><ul><li>Emulsions, suspensions </li></ul></ul><ul><li>Liquids </li></ul><ul><ul><li>Orals, ophthalmic, parenterals </li></ul></ul>
  9. 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. 10. Clinical Trial Supplies Manufacturing <ul><li>GMP Manufacturing </li></ul><ul><ul><li>Tablets, Capsules, Sustained Release, Coatings </li></ul></ul><ul><ul><li>API into Capsule </li></ul></ul><ul><ul><li>Liquid in Capsule </li></ul></ul><ul><ul><li>Semi-solids </li></ul></ul><ul><ul><li>Non-sterile liquid </li></ul></ul><ul><li>Reference Product Blinding </li></ul><ul><li>Packaging and Labeling </li></ul>
  11. 11. Clinical Supplies Expertise <ul><li>Creation of matching placebo formulation </li></ul><ul><li>Creation / qualification of blinded reference product </li></ul><ul><li>Process qualification </li></ul><ul><li>Technology transfer </li></ul><ul><li>Process definition optimization </li></ul>
  12. 12. Enhanced Expertise, Improved Production Times <ul><li>Expanded Roller Compaction Capabilities </li></ul><ul><ul><li>Micromeritics AccuPyc II 1340 Gas Pycnometer </li></ul></ul><ul><ul><li>Micromeritics GeoPyc 1360 Envelope and T.A.P. Density Analyzer </li></ul></ul><ul><li>Expanded Encapsulation Capabilities </li></ul><ul><ul><li>MG Futura – capsule filling for powder and pellets </li></ul></ul><ul><ul><li>LCI multi-granulator MG-55 (extruder) </li></ul></ul><ul><ul><li>QJ-230T marumerizer (spheronizer) </li></ul></ul><ul><ul><li>Wurster insert (bottom spray) for Glatt GPCG-3 fluid bed processor </li></ul></ul><ul><li>New Fully-Automated Packaging Line (including ink-jet coding) </li></ul><ul><ul><li>For primary bottling of tablets and capsules </li></ul></ul>
  13. 13. Market Leading Expertise <ul><li>Speed to FIH Studies </li></ul><ul><li>Market Leading Expertise </li></ul><ul><li>Flexible Options for Experimental Studies </li></ul><ul><li>Global Capacity </li></ul>Accelerate Drug Development Without Sacrificing Quality, Cost or Precious API Xcelodose® is a precision powder micro-dosing system produced by Capsugel
  14. 14. Liquid-in-Capsule <ul><li>Exploit the potential of lipid-based formulations </li></ul><ul><li>Overcome poor solubility </li></ul><ul><li>Improve compound bioavailability </li></ul>
  15. 15. Client Needs Drive Expansion <ul><li>2011 Phase 1 Expansion – Complete </li></ul><ul><ul><li>Expands formulation development capacity, Increases speed </li></ul></ul><ul><li>2011 Phase 2 Expansion – Near Completion </li></ul><ul><ul><li>Expands analytical and formulation development capacity, Increases speed </li></ul></ul><ul><ul><li>Expands manufacturing and packaging capabilities </li></ul></ul><ul><li>2012 Grace Facility Expansion – Planned </li></ul><ul><ul><li>Purpose-built expansion underway </li></ul></ul>
  16. 16. Download Scientific Content Scan the QR code, or visit www.xceliencexpertise.com to access free scientific content