Formulation Development & CTM Manufacturing Services

Transcription

1 Formulation Development & CTM Manufacturing Services VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN Tel: Fax:

2 VxP Pharmaprovides an extensive range of services and technical support for the development and production of sterile and non-sterile products for clinical trial materials. Oral Solid: Oral Liquid: Topical: Tablets, Effervescent Tablets, Capsules, Granulate Solution, Suspension, Emulsion, Liquid-filled capsule Gel, Cream, Ointment, Lotion Transdermal: Single-layer, Double-layer, Reservoir Sterile Liquid: Solution, Suspension, Lyophilized, Emulsion Ophthalmic: Solution, Suspension, Ointment Combination: Multi-layer Tablet, Multi-particulate Drug Delivery Other: Potent, Cytotoxic & Scheduled Compounds (CII-CV)

3 Development Services: Drug Characterization Preformulation Studies Formulation Development Analytical Development Release & Stability Testing Services Overview Manufacturing Services: Clinical Trial Materials GMP and Non-GMP Production Niche Commercial Manufacturing

4 Analytical Services Experienced Professionals in Analytical Chemistry Method development, Qualification and Validation Raw Material Testing (select) Cleaning Analysis/Verification Full Release & Stability Testing Stability Storage ICH Conditions 25 o C/60%RH, 30 o C/65%RH, 40 o C/75%RH Custom conditions also available

5 Formulation Services Solids Tablets, Capsules, Modified Release, Granules, Pellets, Coatings Semi-Solids Creams, Gels, Ointments, Lotions Dispersed Systems Emulsions & Suspensions Liquids/Solutions Oral, Ophthalmic, Parenteral Transdermal

6 Formulation Services We can provide the facilities and expertise to work with your most challenging drug formulation issues: Solubility issues Unstable compounds Innovative delivery options Low dose formulations Controlled drugs (CII CV) High potency compounds Cytotoxic compounds

7 Formulation Services Our scientists have years of experience and the necessary equipment to develop a wide-range of dosage forms: Solubilizing water-insoluble drugs Stabilizing unstable molecules through formulation & excipient selection Taste masking/flavoring Bioavailability enhancement Excipient selection and Compatibility studies Particle size reduction Formulation screening & Feasibility studies

8 Clinical Trial Materials (CTM) Manufacturing We offer technical resources, capacity, flexibility, and the expertise to develop and manufacture virtually any clinical dosage form with strict quality compliance. Processes optimized for future commercial scale-up Pharmaceuticalmanufacturing in support of Phase I-IIIclinical supply needs for solids, liquids, semi-solids, topicals, and transdermals. Including packaging and labeling in: Blister & Strip Packs Bottles, Vials & Syringes Tubes Sachets & Pouches

9 Clinical Trial Materials (CTM) Manufacturing Manufacture of matching placebo for clinical studies. In support of blinded clinical studies, we provide batch manufacturing of matching placebo supplies, as well as supplies for comparator studies. Process qualification and cleaning verification VxP Pharma follows the FDA guidance and incorporates appropriate elements of process validation for the manufacture of human drug products. Full cgmp compliance, accountability and document traceability Compliant with Title 21 CFR Part 11, all data 100% inspected and quality audited to ensure full cgmp manufacturing compliance.

10 Dosage Forms Contract Manufacturing Services API in Capsule/Bottles Tablets Composite, Bi-layer, Tri-layer Coated Capsules Liquid, Solid Coated Over-encapsulation Liquids Solution, Topical, Emulsion, Suspension, Parenteral Transdermals

11 Contract Manufacturing Services Manufacturing Processes Fluid Bed Granulation (Wurster& Top Spray) High/Low Shear Granulation Roller Compaction Direct Compression Tabletting Encapsulation Tablet/Particle Coating (Aqueous& Solvent) Ophthalmic/Otic Solutions/Ointments Contact Us Today for details on Sterile Process Development

12 Contract Manufacturing Services Packaging & Labeling Bulk, Bottles, Sachets, Tubes, Vials, Blisters, Syringes Glass, HDPE, PET, PS, and Protective Coloring Labeling Single Panel, Booklet, Blinded, Randomized, Multi-language Coated Tamper Sealing, Desiccant, Child Resistant Secondary Packaging Cartons Wallets & Dosepacks Complex kits

13 Contract Manufacturing Services Technology Transfer Extensive experiencewith Technology Transfer process from concept to commercialization transfer packages. Our technology transfer experts provide in-depth experience with: Site Transfer Equipment Selection and Validation (IQ, OQ, PQ) Existing Process Optimizations (Lean and Six Sigma) Batch Record Development Validation Protocol Preparation and Execution SOP Development and Method Development Alternate Raw Material Evaluation and Re-formulation Scale-up Assistance from feasibility to commercialization

14 Analytical & Bioanalytical Services VxP Pharmaprovides an extensive range of analytical services and technical support for method development, validation and testing for multiple pharmaceutical and biopharmaceutical applications. API Testing Product Development Testing CMC/Compendial Testing

15 Discover The Benefits Our scientists have expertise in virtually every dosage form giving us the advantage to quickly and effectively create solutions to formulation issues. Ourstaff has over 200+ years of combined experience in contract pharmaceutical development. Ourmanufacturing facilities and development teams are designed to provide you the greatest flexibility while maintaining quality throughout the entire project.

16 THANK YOU For additional information: VxP Pharma Phone: