Xcelience Overview       2013
Core Principles We are all in the business of improving       the quality of human lives. Each of us is joined in the comm...
Xcelience is a premier provider of preformulation, analytical, formulation development, manufacturing andclinical packagin...
Company History1997             2006           2008                          2010             2012                        ...
Convenient LocationcGMP Compliant Tampa, Florida Location•   Laurel Facility (24,000 ft2)•   Grace Facility (24,000 ft2)FD...
Core Competencies Preformulation Services     >   Polymorph Screening, Salt Selection,         Drug Product Characterizat...
Preformulation ServicesSolid and Solution CharacterizationDrug substance characterization can be conducted using the   fol...
Analytical Services Method Development,  Qualification, and Validation Technical Packages for Drug  Substances HPLC/Dis...
Analytical Instrumentation•   Equipment     – HPLC: 30 instruments, Waters and Agilent     – UPLC: 2     – GC w/ Headspace...
Formulation Services Solids   > Tablets, capsules, sustained release, coatings Semi-Solids   > Ointments, creams/emulsio...
Formulation Development for                                   Poorly Soluble CompoundsConventional Formulations/Processes ...
Manufacturing Manufacturing                 Additional Expertise   > Tablets and capsules          > Creation of matchin...
Partnering Advantage                                                           Partnering with Xcelience can reduce       ...
Market LeadershipPowder-in-Capsule > Faster time to FIH studies > Market leading experience        > 100 APIs, >130 batch...
Stability• ICH conditions• Protocol design• Report generation• Stability software management system• Sample analysis• Secu...
Enhanced Expertise,                                        Improved Production Times Expanded Roller Compaction Capabilit...
Clinical Packaging Services Primary packaging      Filling of API into bottles (AIB)      Filling of API into capsules ...
Four Phase Facility ExpansionPhase 1: Laurel Expansion – Complete  > Expands formulation development capacity, Increases s...
Download Scientific ContentScan the QR code, or visitwww.xceliencexpertise.comto access free scientificcontent
Unique Advantage  Market Leading             Performance                   Sound    Expertise                  Culture    ...
Choose XcelienceQuality-First Focus. Expertise. Flexibility.                Partnership
Thank you!For more information please contact:Sharon Burgess   Email:   sharon.burgess@xcelience.com   Phone: 603-226-4060...
Xcelience linked in2013
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Xcelience linked in2013

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Transcript of "Xcelience linked in2013"

  1. 1. Xcelience Overview 2013
  2. 2. Core Principles We are all in the business of improving the quality of human lives. Each of us is joined in the commitment to reach critical milestones faster, deliverclinical materials on time, control costs, and above all to ensure quality.At Xcelience, we commit to hold ourselves to ever-increasing high standards of quality,service performance, and drug development expertise that in turn enable our clients toovercome drug development challenges and improve chances for compound success.We are early drug development made easy – at last.
  3. 3. Xcelience is a premier provider of preformulation, analytical, formulation development, manufacturing andclinical packaging solutions with an established reputation for accelerating project timelines. 2012 Regulatory Recognition Top 10 CMO in 2012
  4. 4. Company History1997 2006 2008 2010 2012 Grace Street Established Xcelience CEO Finalist for E&Y 2008 CEO Cancer Expansion as Tricon Formed Entrepreneur of the Year Gold Standard Completed for by MBO Accreditation Tampa Chamber of Expanded Clinical Commerce Small Business Supplies Award Finalist Purchased Tampa Chamber of Acquired by 4 Phase Grace Street Commerce Small Top 6 Global Facility for Business Award CRO Expansion Expansion Finalist (2nd Year) 1998 2007 2009 2011
  5. 5. Convenient LocationcGMP 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• I to V Analytical–DEA Inspected 2012, January• II to V Manufacturing–DEA Inspected 2010, January• I to V Analytical–DEA Inspected 2009, DecemberFlorida Dept. of Health Audit• State of Florida Inspected 2010, SeptemberEuropean Union Requirements• Multiple Qualified Person (QP) Audits
  6. 6. Core Competencies Preformulation Services > Polymorph Screening, Salt Selection, Drug Product Characterization Analytical Services > Method Development and Validation, Waters and Agilent Instrumentation Formulation Development > Solids, Semi-solids, Oral Liquids Manufacturing, Packaging and Labeling > Solids, Semi-solids, Oral Liquids > Direct Fill API into Capsules > Matching placebo formulation > Blinded reference product > Bottling or Blister Packaging Stability Program Management Broad variety of temperature and humidity conditions
  7. 7. Preformulation ServicesSolid and Solution CharacterizationDrug substance characterization can be conducted using the following equipment (tests): – Thermal evaluation (DSC, TGA and/or Hot Stage) – Particle Size – FTIR – XRD – Morphology analysis (polarized microscope) – pKa determination (calculated or experimental) – log P / log D determination – Moisture content (Karl Fischer) – Moisture sorption profile (VSA) – pH solubility profiles – Solubility studies (visual, HPLC and/or UV)
  8. 8. Analytical Services Method Development, Qualification, and Validation Technical Packages for Drug Substances HPLC/Dissolution Testing Residual Solvent Analysis Raw Material Testing Stability Sample Analysis Chiral Determination Cleaning Evaluations Stability Program Mgmt and Sample Analysis
  9. 9. Analytical Instrumentation• Equipment – HPLC: 30 instruments, Waters and Agilent – UPLC: 2 – GC w/ Headspace – Dissolution Stations w/ autosamplers: 9 instruments, Vankel and Distek (apparatus 1 & 2 - bath and bathless) – UV/Vis – FTIR – Karl Fischer: Coulometric and Volumetric – Brookfield Viscometer
  10. 10. Formulation Services Solids > Tablets, capsules, sustained release, coatings Semi-Solids > Ointments, creams/emulsions, gels Dispersed Systems > SEDDS/SMEDDS, suspensions Liquids > Orals > Parenterals (tox only)
  11. 11. Formulation Development for Poorly Soluble CompoundsConventional Formulations/Processes Alternate Processing Use water soluble excipients  Add drug to aqueous granulating Micronize the API solution containing wetting/solubilizing agent pH modifiers  Dissolve API in hydroalcoholic/ > citric acid, succinic acid etc alcoholic granulating solution Solubilizing/wetting agents > May alter API characteristics > sodium laurel sulfate, Tween 80  Form Solid dispersion/solution in hot melt process using CFS1200™  Complexing agents (Cyclodextrins)  Liquid fill hard gelatin capsule
  12. 12. Manufacturing Manufacturing  Additional Expertise > Tablets and capsules > Creation of matching placebo • Sustained release formulation • Coatings > Creation and qualification of > API in a capsule blinded reference product > Liquids in a capsule > Process qualification • Suspensions > Technology transfer • Emulsions > Process definition optimization > Semi-solids > Non-sterile liquid Reference Product Blinding Packaging and Labeling
  13. 13. Partnering Advantage Partnering with Xcelience can reduce product risk and accelerate timelines for early phase drug developmentAPI in Capsule Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16API Characterization 1 2 3 4 5 6 7 8 9 10 11 12Analytical - API Method Evaluation / Dev 1 1 2 3 4 5 6 7 8Analytical - DP Evaluation / Method Dev 1 2 3 4 5 6 7 8Feasibility Study - Capsule Compatibility 1 2 3 4Create and Approve GMP Batch Records 1 13 WeeksManufacture GMP Batches 1 2Release Testing of GMP Material 1 2Initiate ICH Stability Study 1Traditional Formulation Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29API Characterization 1 2 3 4 5 6 7 8 9 10 11 12Exipient Compatibility 1 2 3 4 5 6 7 8 9 10 11 12 13 14Formulation Development / Selection 1 2 3 4 5 6 7 8Analytical - DP Evaluation / Method Dev 1 2 3 4 5 6 7 8Prototype Stability 1 2 3 4 5 6 7 8 9 10 11 12Create /Approve GMP Batch Records 1Manufacture of GMP Batches 1 2Release Testing of GMP Material 1 2Initiate ICH Stability Study 1 Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Accelerate Timelines. Conserve API. Minimize Downstream Problems.API Characterization 1 2 3 4 5 6 7 8 9 10 11 12Excipient Compatibility 1 2 3 4 5 6 7 8 9 10 11 12 13 14DevDevelopment 1 2 3 4 5 6Formulation Development / Selection 1 2 3 4 5 6 7 8Analytical - DP Eval./ Method Dev 1 2 3 4 5 6 7 8Prototype Stability 1 2 3 4 5 6 7 8 9 10 11 12
  14. 14. Market LeadershipPowder-in-Capsule > Faster time to FIH studies > Market leading experience  > 100 APIs, >130 batches > Defined programs, proven results  API into capsule projects are on average completed 45% faster than traditional formulation development efforts, shave 13-17 weeks from total development time > Greater global capacity  Three dedicated Xcelodose® systems  3 NA, 1 EU  Xcelodose® systems in the experimental area enable clients to use laboratory grade material for dispensing head selection, filling process evaluation, capsule compatibility, or to fill powder into capsule (PIC) for preclinical studies.
  15. 15. Stability• ICH conditions• Protocol design• Report generation• Stability software management system• Sample analysis• Secure storage area
  16. 16. 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
  17. 17. Clinical Packaging Services 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 Package engineering and design  Tooling, card/wallet (CR) and patient kits Global procurement of comparator medications  Supported with product pedigree documents
  18. 18. Four Phase Facility ExpansionPhase 1: Laurel Expansion – Complete > Expands formulation development capacity, Increases speedPhase 2: Laurel Expansion – Complete > Expands analytical and formulation development capacity, Increases speed > Expands manufacturing and packaging capabilitiesPhase 3: Laurel Expansion – Complete > Renovation and expansion of the existing cGMP manufacturing/packaging areaPhase 4: Grace Facility Expansion – Complete > Purpose-built expansion of new primary and secondary clinical packaging facility
  19. 19. Download Scientific ContentScan the QR code, or visitwww.xceliencexpertise.comto access free scientificcontent
  20. 20. Unique Advantage Market Leading Performance Sound Expertise Culture ManagementRecognized formulation Scheduling flexibility, Conservative financialdevelopment expertise FTE programs managementProven expertise with Disciplined project Diversified client mixlow dose formulations management Minimal employeeStreamlined equipment No double-booking, turnover, retainedfrom experimental to 99% on-time completion project knowledgeGMP record Ability to attract andAPI sparing strategies Quality systems ensure retain top talentminimize waste safe handling of cytotoxic / potent compounds
  21. 21. Choose XcelienceQuality-First Focus. Expertise. Flexibility. Partnership
  22. 22. Thank you!For more information please contact:Sharon Burgess Email: sharon.burgess@xcelience.com Phone: 603-226-4060 Cell: 603-731-3691 Fax: 603-415-3330
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