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November 2011
CoreRx, Inc OverviewOur 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
Our Core Focus
• Complete client satisfaction
• Highest quality science
• Consistent and effective communications
• Strong timeline management
• Full attention to client goals at all levels
Why CoreRx?• People and Expertise
It all boils down to people and trust..
• CommunicationEffective, Scientist-to-Scientist communication is the cornerstone to every CoreRx™ project’s success.
• FlexibilityCoreRx™ scientists, management, and systems ensure flexibility and agility, allowing for direction changes without inflexible systems and bureaucratic hassles.
• SpeedCoreRx™ 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 systemsDocumentation, quality, and operational systems are a necessity in a GLP/cGMP environment. Quality & timeliness must go hand in hand.
Why CoreRx…?
• Oh yes… and Location
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
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
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
New 2012 CoreRx Facility Overview
• Approximately 35,000 square feet• 19 Manufacturing suites13 cGMP – including 1 for cytotoxic projects6 Non-GMP – formulation development
• Manufacturing capacity – up to ~500kg• Expanded laboratory space:•Formulation Development•cGMP Manufacturing•Stability storage testing•Analytical
•R&D•cGMP
Convenient Location
Tampa, Florida<10 minutes to Tampa Airport (TPA)
cGMP Compliant
FDA/FL DOH Registered
DEA LicensedSchedule II - V
And In 2012: Convenient Location
Clearwater, Florida~15 minutes to Tampa Airport (TPA)
cGMP Compliant
FDA/FL DOH Registered
DEA LicensedSchedule II - V
Insert new map
New Location – Facility Layout
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
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
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
Introducing SuiteViewTM…
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
SERVICES
Preformulation
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
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
Analytical Services
• Analytical Support for Formulation Development
• Stability and QC Release Testing• API/Reference Standard Characterization• Isolation and Identification of Impurities• Physical Chemistry
Formulation Services
• Solids• Tablets, Capsules, Modified Release, Coatings
• Semi-Solids• Creams, Gels, Ointments, lotions, etc.
• Dispersed Systems• Emulsions & Suspensions
• Liquids• Oral, Ophthalmic, Parenteral
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
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
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
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
• Sample analysis• Secure storage
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
Choose CoreRx
The projects we work on may change....
our values won't...
quality, reliability, value,
integrity
www.corerxpharma.com