VxP Pharma - Corporate Overview

VxP Pharma8520 Allison Pointe Blvd.

Suite 220Indianapolis, IN 46250

Tel: 317.759.2299Fax: 317.713.2950

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 “One-Size-Fits-All” CRO, you are instead working directly with some of the best subject matter experts in the industry at specialist, independent, “niche” facilities.  

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.

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

Discovery Chemistry/Research

Structure-Based Design Lead Optimization Parallel Synthesis

We can support: Custom synthesis Novel molecular building blocks SAR data

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.

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

Preclinical  Toxicology

A complete range of PK/TK services are available to support animal models, and/or pre clinical studies. 

PharmacologyThe 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)The laboratories of VxP offer fully validated and networked management systems for multiple study types, including radioisotopic, chromatographic, and pharmacokinetic evaluations. 

Medical Device BiocompatibilityWith 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. 

HistopathologyThe histo laboratory of VxP produces high quality slides, clinical chemistry and hematology data with fully integrated and detailed pathology reports.

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.

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

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

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

Formulation Development

Complex Formulations Insoluble Compounds Overencapsulation Bioavailability Enhancement Dissolution Testing

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.

Parenteral & Lyophilized CTMs

Parenteral Formulations and Fill/Finish Lyophilization Cycle Development & Optimization Lyophilization Filter Function Evaluation & Validation Highly Potent & Cytotoxic Compounds Microbiological Testing

THANK YOU

For additional information:

VxP Pharmawww.vxppharma.comPhone:  317.759.2299

Email:  info@vxppharma.com