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Core rx presentation_2012
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- 2. CoreRx, Inc Overview Our Core Business CoreRx, Inc. is a Dosage Form Development company specializing in formulation development, analytical development and clinical manufacturing of various dosage forms • 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? • Peopleand 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…? • Ohyes… and Location
- 7. Executive/Scientific Team • ToddR. 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 • MarkJ. 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 suites 13 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
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- 18. Preformulation Characterization Solid and/orSolution 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 Services Experienced Professionalsin 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 Services Solid OralCapabilities • 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…? • QualityFirst 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 Clinicwith 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 evenFaster 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 CoreRx The projectswe work on may change.... our values won't... quality, reliability, value, integrity
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