VxP Pharma - Corporate Overview


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Our Corporate Presentation is a high-level overview of the services provided by VxP Pharma, and includes other pertinent information about the company.

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VxP Pharma - Corporate Overview

  1. 1. VxP Pharma 8520 Allison Pointe Blvd. Suite 220 Indianapolis, IN 46250 Tel: 317.759.2299 Fax: 317.713.2950
  2. 2. Who is VxP Pharma? VxP Pharma is a CRO who provides pharmaceutical development services,  and technical support, for the development and production of  pharmaceuticals, diagnostics, and drug/device combination products  through the independently owned and operated, “pre-audited” facilities  that are part of VxP.  When you work with VxP, rather than working with a generalist “OneSize-Fits-All” CRO, you are instead working directly with some of the best  subject matter experts in the industry at specialist, independent, “niche”  facilities.  
  3. 3. What makes VxP Pharma different? • When you work with VxP, you’ll collaborate directly with dedicated  experts in each area of development, and not simply a “generalist” who  happens to be assigned to your project. • The Solid State Chemistry lab only performs solid state chemistry, and the  preclinical facility performs only services needed during preclinical  development. Because they focus on their core competencies, the subject  matter experts at each of the locations are among the world’s best. • We’re able to deliver this unique capability because each facility is  independently owned and operated, and specializes in only one area of  development.
  4. 4. Services Overview • • • • • • • • • Discovery Chemistry/ Research Chemical Development Preclinical Preformulation & Solid State Chemistry Analytical & Bioanalytical Formulation Development cGMP Clinical Trial Materials Manufacturing Reagent Assay Development Parenteral and Lyophilized Clinical Trial Materials
  5. 5. Discovery Chemistry/Research • Structure-Based Design • Lead Optimization • Parallel Synthesis We can support: • Custom synthesis • Novel molecular building blocks • SAR data
  6. 6. Chemical Development • • • • • • Chemical Process Development & Optimization cGMP/Non-GMP API Synthesis GLP/GMP for Small Molecules GLP/GMP for Macromolecules Regulatory Support Radiolabeled Compounds VxP Pharma is a valuable resource for a variety of your chemical development needs, from pre-clinical support and process R&D to multi kg-scale synthesis.
  7. 7. Synthesis Capabilities • • • • • • • • • • Building Block Chemistries Scalable up to 10 Kg quantities Novel Route Design Literature Synthesis Reference Standards Marker Compounds Pharmaceutical Intermediates Cold and Hot Labeled Synthesis Medicinal Chemistry Libraries cGMP Production of NCE’s
  8. 8. Preclinical • Toxicology • Pharmacology • ADME, DMPK (In-vivo/In-vitro) • Medical Device Biocompatibility • Histopathology A complete range of PK/TK services are available to support animal models, and/or pre clinical studies. The pharmacology team has extensive drug discovery and development experience and a complete range of GLP/Non-GLP laboratory services available to support fully integrated programs with study design and data interpretation. The laboratories of VxP offer fully validated and networked management systems for multiple study types, including radioisotopic, chromatographic, and pharmacokinetic evaluations. With extensive expertise in anatomical and clinical pathology, as well as state-of-the-art facilities, VxP Pharma can provide complete service and support to device manufacturers. The histo laboratory of VxP produces high quality slides, clinical chemistry and hematology data with fully integrated and detailed pathology reports.
  9. 9. Preformulation & Solid State Chemistry • • • • • • • Salt Selection Polymorphism Cocrystals Amorphous Solid Dispersions Solution-state Stability Solid-state Stability Flowability Support from the manufacturing staff and development experts will ensure you quickly receive the best formulation of your specific drug compound. We offer a full range of solid state manufacturing, testing, and stability services.
  10. 10. Analytical & Bioanalytical • • • • • • • • • • Analytical Method Development & Validation Extractables & Leachables Studies Particle Size Determination Container – API Compatibility Material Characterization Forced Degradation & Stability Studies Drug – Device Compatibility Studies Flow Cytometry Microbiological Testing Bioanalytical Testing
  11. 11. CTM Manufacturing • • • • Phase I – IIb CTM and Commercial Scale Manufacturing IND/First-In-Man Enabling Studies Highly Potent and Cytotoxic Compounds All major dosage forms
  12. 12. Dosage Forms • • • • • • • • • • Tablets : IR/SR/CR Release, Combo Products, Film-coated Capsules : Powder, Granule, Liquid filling Pellets : Compressed into tablets or filled in capsules Powders : Powder in a bottle Parenteral solutions and lyophilized products Liquids : Solutions, Suspensions, Emulsions Semi-solids : Creams, Ointments, Gels, Lotions Transdermal Solid Dispersions Nanoparticles
  13. 13. Formulation Development • • • • • Complex Formulations Insoluble Compounds Overencapsulation Bioavailability Enhancement Dissolution Testing
  14. 14. Reagent Assay Development • ELISA-based Immunoassays VxP Pharma can provide ELISA-based Immunoassay testing services from initial concept to validation and custom assay development for all sandwich ELISA, EIA, and Phosphorylation ELISA kits. All assays can be provided to meet GLP/GMP guidelines (or non-GLP as requested). • Custom Assay Development The custom assay development services of VxP are directed towards the client’s needs by providing qualified chemists and laboratory resources for implementing a variety of assay testing methods.
  15. 15. Parenteral & Lyophilized CTMs • • • • • • Parenteral Formulations and Fill/Finish Lyophilization Cycle Development & Optimization Lyophilization Filter Function Evaluation & Validation Highly Potent & Cytotoxic Compounds Microbiological Testing
  16. 16. THANK YOU For additional information: VxP Pharma www.vxppharma.com Phone: 317.759.2299 Email: info@vxppharma.com
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