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. VxP Pharma
8520 Allison Pointe Blvd.
Suite 220
Indianapolis, IN 46250
Tel: 317.759.2299
Fax: 317.713.2950
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. 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
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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
6. Chemical Development
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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
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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. Preclinical
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Toxicology
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Pharmacology
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ADME, DMPK (In-vivo/In-vitro)
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Medical Device Biocompatibility
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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. Preformulation & Solid State Chemistry
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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.
11. CTM Manufacturing
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Phase I – IIb CTM and Commercial Scale Manufacturing
IND/First-In-Man Enabling Studies
Highly Potent and Cytotoxic Compounds
All major dosage forms
12. Dosage Forms
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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
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.