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Core rx presentation_2012


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  • 1.
  • 2. CoreRx, Inc Overview Our Core BusinessCoreRx, Inc. is a Dosage Form Development companyspecializing in formulation development, analyticaldevelopment and clinical manufacturing of various dosageforms• Drug Characterization• Preformulation• Formulation Development• Analytical Development• Clinical Trial Materials Manufacturing
  • 3. Our Core Focus• Complete client satisfaction• Highest quality science• Consistent and effective communications• Strong timeline management• Full attention to client goals at all levels
  • 4. Why CoreRx?• People and Expertise It all boils down to people and trust..• Communication Effective, Scientist-to-Scientist communication is the cornerstone to every CoreRx™ project’s success.• Flexibility CoreRx™ scientists, management, and systems ensure flexibility and agility, allowing for direction changes without inflexible systems and bureaucratic hassles.
  • 5. Why CoreRx?• Speed CoreRx™ understands that developing innovative solutions for improved patient care, combined with the bottom line, revenues and profitability, are tied to getting your product on the market as quickly as possible.• Education Affiliation with Univ. of South Florida as Center for Advanced Pharmaceutical Learning. Students will learn hands-on techniques in industrial pharmaceutics from member of CoreRx team who are Associate Faculty at USF.• Quality systems Documentation, quality, and operational systems are a necessity in a GLP/cGMP environment. Quality & timeliness must go hand in hand.
  • 6. Why CoreRx…?• Oh yes… and Location
  • 7. Executive/Scientific Team• Todd R. Daviau, Ph.D. - Chief Executive Officer – 25+ years of pharmaceutical experience – Director of the Analytical Group for MDS Pharma Services – Guilford Pharmaceuticals (GliadelTM) – Nova (later Scios) Pharmaceuticals• Brian McMillan, Vice President, Formulation Development – 20+ years of experience in pharmaceutical formulation development – MDS Pharma Services – Bausch and Lomb Pharmaceuticals – Roxane Laboratories
  • 8. Executive/Scientific Team• Mark J. Licarde, Vice President, Technical Operations – 28+ years in pharmaceutical manufacturing – MDS Pharma Services – Mylan Pharmaceuticals – Bristol Myers Squibb• Jim Davis, M.S., Vice President, Business Operations – 16+ years of pharmaceutical experience – MDS Pharma Services – Bausch and Lomb – Proceutics / Oread
  • 9. History• Founded in 2006• Started with 5 employees• Now at 41 employees• Grown from 3300 sq. ft. to over 35,000 sq ft.
  • 10. CoreRx’s Convenient Location Clearwater, Florida ~15 minutes to Tampa Airport (TPA)Insert new map cGMP Compliant FDA/FL DOH Registered DEA Licensed Schedule II - V
  • 11. CoreRx Facility Overview• Approximately 35,000 square feet• 19 Manufacturing suites13 cGMP – including 1 for special projects (low RH, low light, etc.)6 Non-GMP – formulation development• Manufacturing capacity – up to ~500kg• Expanded laboratory space:•Formulation Development•cGMP Manufacturing•Stability storage testing•Analytical •R&D •cGMP 
  • 12. Formulation Suites cGMP Manufacturing New Location Area Warehouse Analytical Labs Admin areas
  • 13. Core Competencies by Business Unit• Preformulation Services – Drug substance characterization• Analytical Services – Method Development and Validation• Formulation Development – Liquids, Semi-solids and Solids• Manufacturing, Packaging & Labeling – API in Capsule or in Bottle – Liquids, Semi-solids and Solids – Matching Placebo manufacture – Blinding of reference product (over-encapsulation)• Stability Program Management – ICH or customized stability parameters
  • 14. Additional Capabilities• CoreRx is committed to adding innovation where we see a client need – API in capsule/bottle services • Xcelodose ® • Quantos® – Multi-layer tablet (up to 3 layers) • FlexiTab ® – Liquid in capsule services – Multi-particulate capsules• CoreRx licensed with DEA – Controlled substances (II – V)• Overencapsulation services – comparator or “blinding” studies
  • 15. Project Management/Logistics• Project Manager is assigned to manage: – Project planning and Execution – Team leadership with integration of technical – Manage all CoreRx-Client communications• Project Teams are made up of subject matter experts which represent their respective disciplines: – Project Management/Logistics – Analytical Chemistry – Formulation Development – Manufacturing – Quality Assurance
  • 16. SERVICES
  • 17. Preformulation
  • 18. Preformulation CharacterizationSolid and/or Solution Characterization can be Conducted Utilizing the Following Instrumentation/Procedures: • Thermal evaluation • DSC, TGA, Hot-stage microscope • FTIR • X-ray Diffraction • Particle size/morphology • Polarized microscopy • Moisture content • KF, moisture analyzer • Moisture sorption profile • pH solubility • Partition coefficient • Photostability • Intrinsic dissolution
  • 19. Analytical ServicesExperienced Professionals in Analytical Chemistry • Method Development, Qualification and Validation • HPLC, uPLC, Dissolution, etc. • Raw Material Testing (select) • Stability Sample Analysis • Dissolution Testing • Chiral Analysis • Cleaning Analysis/Verification • CMC Technical Packages
  • 20. Analytical Services• Analytical Support for Formulation Development• Stability and QC Release Testing• API/Reference Standard Characterization• Isolation and Identification of Impurities• Physical Chemistry
  • 21. Formulation Services• Solids • Tablets, Capsules, Modified Release, Coatings• Semi-Solids • Creams, Gels, Ointments, lotions, etc.• Dispersed Systems • Emulsions & Suspensions• Liquids • Oral, Ophthalmic, Parenteral
  • 22. Formulation ServicesSolid Oral Capabilities • API in Bottle/Capsule • Excipient Compatibility • Oral Drug Delivery • Tablets, Capsules, Powders, Pellets, Mini-Tablets • Solutions, Suspensions, Emulsions, Powders for Reconstitution • Solid Dispersions • Lipid Formulation Delivery for Poorly Soluble/Bioavailable APIs • Multi-Phasic, Extended and/or Delayed Release Drug Delivery • Highly Potent Compounds
  • 23. Contract Manufacturing Services• Manufacturing – API in Capsule/Bottles – Tablets, Capsules, Pellets, Mini-Tablets – Liquid in Capsule • Solutions, Suspensions, Emulsions• Over-Encapsulation, Reference Product Blinding• Packaging & Labeling• Other Services – Matching Placebo Manufacturing – Technology Transfer
  • 24. Stability• ICH Conditions – 25oC/60%RH, 30oC/65%RH, 40oC/75%RH – Custom conditions also available• Protocol design• Report generation• Stability software management system – SLIM/SLIMStat• Sample analysis• Secure storage
  • 25. Why CoreRx…?• Quality First Focus – Numerous audits reinforcing compliance• Responsiveness – Flexible manufacturing model – Unique project management team structure with client-centric focus – Cross training program for employees• Technology – Investment in new equipment and expertise as they become available• Expertise – Ability to attract top-level talent with high-level benefits package• Reliability – Leveraging our company’s size to your advantage
  • 26. Faster to Clinic with Xcelodose ® or Quantos®• Manufacturing – Advanced neat drug dosing directly into capsule or bottle – Decreases lab to clinic development – Decreases API requirements – Decrease risk of stability – Minimizes API waste
  • 27. …and now even Faster to Clinic with ClinicFirstSM 60Day Guarantee• The CoreRx ClinicFirst program is designed for clients requiring rapid supply of clinical trial materials for First-in- Man (Phase I) clinical studies.• API in Capsule• Blend in Capsule• API in Bottle• Blend in Bottle
  • 28. Introducing SuiteViewTM…• Formulation & Manufacturing – Real-time video feed (Pan, Tilt & Zoom) – Remote/IP access • Password controlled – Two way communication • Reduce travel time/costs
  • 29. Choose CoreRxThe projects we work on may change.... our values wont... quality, reliability, value, integrity
  • 30.