Core Rx Presentation
- 2. CoreRx, Inc Overview Our Core Business CoreRx, Inc. is a Dosage Form Development company specializing in formulation development, analytical development and clinical/(niche) commercial manufacturing of various dosage forms Drug Characterization Preformulation Formulation Development Analytical Development Clinical Trial Materials/(Niche) commercial 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. 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. Quality systems Documentation, quality, and operational systems are a necessity in a GLP/cGMP environment. Quality & timeliness must go hand in hand.
- 5. Why CoreRx…? Oh yes… and Location
- 6. Executive/Scientific Team Todd R. Daviau, Ph.D. President/CEO 25+ years of pharmaceutical experience Vice President of the Analytical for MDS Pharma Services Nova Pharmaceuticals (Scios Pharmaceuticals) Guilford Pharmaceuticals Brian McMillan, VP - Product Development 20+ years of experience in pharmaceutical formulation development MDS Pharma Services Bausch and Lomb Pharmaceuticals Roxane Laboratories
- 7. Executive/Scientific Team Mark J. Licarde, VP - Manufacturing 28+ years in pharmaceutical manufacturing MDS Pharma Services Mylan Pharmaceuticals Bristol Myers Squibb Jim Davis, M.S., VP - Analytical Services 15+ years of analytical chemistry experience MDS Pharma Services Bausch and Lomb
- 8. History Founded in 2006 Started with 5 employees Now at 26 employees Grown from 3300 sq. ft. to over 10,000 sq ft. New 35,000 sq ft. facility purchased in December 2010 – now undergoing a $5 million facility expansion
- 9. New 2012 CoreRx Facility Overview Approximately 35,000 square feet 19 Manufacturing suites 13 cGMP – including 1 for cytotoxic projects 6 Non-GMP – formulation development Manufacturing capacity – up to ~500kg Expanded laboratory space: Formulation Development cGMP Manufacturing Stability storage testing Analytical R&D cGMP
- 10. Convenient Location Tampa, Florida <10 minutes to Tampa Airport (TPA) cGMP Compliant FDA/FL DOH Registered DEA Licensed Schedule II - V
- 11. And In 2012: Convenient Location Clearwater, Florida ~15 minutes to Tampa Airport (TPA) cGMP Compliant FDA/FL DOH Registered DEA Licensed Schedule II - V Insert new map
- 12. New Location – Facility Layout
- 13. Core Competencies 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. Introducing SuiteView TM … The first of it’s kind Client Communication System Cameras in Formulation & Manufacturing Real-time video feed Remote/IP access Password controlled Two way communication Reduce travel time/costs
- 17. SERVICES
- 18. Preformulation
- 19. Preformulation Characterization Solid 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
- 20. Analytical Services Experienced 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
- 21. Analytical Services Analytical Support for Formulation Development Stability and QC Release Testing API/Reference Standard Characterization Isolation and Identification of Impurities Physical Chemistry
- 22. Formulation Services Solids Tablets, Capsules, Modified Release, Coatings Semi-Solids Creams, Gels, Ointments, lotions, etc. Dispersed Systems Emulsions & Suspensions Liquids Oral, Ophthalmic, Parenteral
- 23. Formulation Services Solid 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
- 24. 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
- 25. 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
- 26. Stability ICH Conditions 25 o C/60%RH, 30 o C/65%RH, 40 o C/75%RH Custom conditions also available Protocol design Report generation Stability software management system SLIM Sample analysis Secure storage
- 27. 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
- 28. Choose CoreRx The projects we work on may change.... our values won't... quality, reliability, value, integrity