01 alliance pharma - your trusted partner in bioanalysis and dmpk support-matthew cyronak - alliance...

Your Trusted Partner in Bioanalysis and DMPK Support

www.AlliancePharmaco.com

Company Overview

• Contract research organization (CRO) specializing in bioanalysis and DMPK support for the pharmaceutical and biopharmaceutical industries

• Located in Malvern, Pa with a 36,800 sq. ft. facility capable of accommodating up to 22 labs

• Teams consisting of scientists with extensive and diverse industrial experience, including CROs and major pharmaceutical companies, most of whom have advanced degrees


Our Strengths

We specialize in drug metabolism and pharmacokinetic (DMPK) support, as well as bioanalytical services for both small and large

molecules.

Our extensive and diverse capabilities include: • New drug, metabolite, or generic drug assays • Small molecule LC-MS/MS analysis • Immunoassays • Cell based assays • Small molecule metabolite profiling and identification • Pharmacokinetic modeling and design


BioanalysisOur bioanalytical team has extensive experience in developing and validating

robust LC-MS/MS methods for a wide variety of compounds in various biological matrices (including blood, urine, and tissue specimens) to support

all phases of pre-clinical and clinical studies.

Services include: • Method transfer and optimization • Method development and validation • Support for pre-clinical TK/PK studies • Analytical support for clinical trials

– Pharmacokinetic (PK) studies – Bioequivalence studies

• High throughput analysis to support discovery TK/PK/PD studies


Bioanalysis


BIOANALYTICAL SERVICES

In Vivo PK/TK/TD Screening

In Vitro Screening

Analysis of Drugs in Biological Matrices, Plants,

Formulations and Environmental Matrices

Quantitative Analysis of Active Compounds and

Metabolites

LC-MS/MS Method Development and

Validation

DMPK Support


Our expertise in the field of drug metabolism allows us to provide optimal results to our clients in the most efficient and

cost effective manner.

Lead Identification Services:• Metabolic Stability (intrinsic clearance) • Direct and Mechanism-Based Inhibition • CYP Induction • Protein Binding in Plasma/Whole Blood • Drug-drug interactions between small molecules and

biologics

DMPK Support


Lead Optimization Services:• Reaction Phenotyping • MDCK/MDCK-MDR1 Cell Permeability • Metabolite Profiling, Isolation, Purification and Identification • Predictive Routes of Metabolism and Potential Toxicity • In vitro species comparisons for appropriate pre-clinical

animal model selection

Biopharmaceutical Services


BIOPHARMACEUTICAL

SERVICES

Cell Based Assay

Receptor Binding Signal Transduction

Drug Potency Transporter Cytotoxicity

Genotoxicity

Immunogenicity

ADA Screening Confirmation

Titer Assessment nAB Characterization

Molecular Biology

Genotyping Hybridization

Gene Expression RNAi Mutation

Methylation

Immuno-Bioanalytical(ELISA/MSD)

Assay Development Method Validation

Sample Analysis (PK/TK)

Single & Multiplex Biomarkers

Business Philosophy


We Believe In Professional Ethics, Scientific Excellence And Regulatory Compliance

Our Mission Is To Build A Trusted PartnershipWith Our Clients By Offering High Quality

Services, Competitive Pricing & Quick Turnaround Time

Our Success Is Measured By The Success Of Our Clients.

Contact Information


Alliance Pharma, Inc.17 Lee Boulevard

Malvern, Pa 19355

Phone: 610.296.3152Fax: 610.296.3153

Website: www.alliancepharmaco.com

http://www.alliancepharmaco.com/

01 alliance pharma - your trusted partner in bioanalysis and dmpk support-matthew cyronak - alliance...

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