VxP Pharma provides pharmaceutical development services and technical support for developing and producing pharmaceuticals, diagnostics, and drug-device combination products. It offers services across discovery, development, preclinical testing, formulation, manufacturing, and commercialization. VxP differentiates itself by having dedicated subject matter experts that focus on specific areas of development rather than generalists assigned to projects.
1. VxP Pharma
Purdue Research Park
5225 Exploration Drive
Indianapolis, IN 46241
Tel: 317.759.2299
Fax: 317.713.2950
Corporate Overview
2. Who is VxP Pharma?
VxP Pharma provides an extensive range of
pharmaceutical development services and
technical support for the development and
production of pharmaceuticals, diagnostics,
and drug/device combination products.
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. Services Overview
• Discovery Chemistry/ Research
• Chemical Development
• Preclinical
• Cell Line Engineering & Gene Modification
• Preformulation & Solid State Chemistry
• Analytical & Bioanalytical
• Formulation Development
• cGMP Clinical Trial Materials Manufacturing
• Commercial Services
• Parenteral and Lyophilized Clinical Trial Materials
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. 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. • Toxicology
A complete range of PK/TK services are available to support animal models, and/or pre clinical
studies.
• Pharmacology
Our 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.
• ADME, DMPK (In-vivo/In-vitro)
Our laboratories offer fully validated and networked management systems for multiple study
types, including radioisotopic, chromatographic, and pharmacokinetic evaluations.
• Medical Device Biocompatibility
With our expertise in anatomical and clinical pathology and our state-of-the-art laboratories, VxP
Pharma can provide complete service and support to device manufacturers.
• Histopathology
Our laboratory produces high quality slides, clinical chemistry and hematology data with fully
integrated and detailed pathology reports.
Preclinical Services
10. Preformulation & Solid State Chemistry
• Salt Selection
• Polymorphism
• Cocrystals
• Amorphous Solid Dispersions
• Solution-State Stability
• Solid-State Stability
• Flowability
Support from our 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.
12. 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
13. 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
• Hot Melt Extrusions
• Nanoparticles
16. Commercial Manufacture
• Experience with manufacturing and packaging solid oral dosage forms
(tablets, capsules & powders) for the global commercial market
• Wide range of processing equipment
• State of the art equipment list for commercial scale
• Provides flexibility to match batch size needed
• Blend sizes up to 2.5 tons
• 15,000 ft² building for Commercial-scale Aseptic and Ophthalmic
• We also have a range of facilities delivering Grams to Multi-ton scale intermediates and
API for clinical and commercial requirements
* We are licensed to process/store all schedules of Controlled Drugs.
17. THANK YOU
For additional information:
VxP Pharma
www.vxppharma.com
Phone: 317.759.2299
Email: info@vxppharma.com
