Alliance Pharma
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Malvern, Pennsylvania, US
Alliance Pharma is a Contract Research Organization (CRO) specializing in Drug Metabolism and Pharmacokinetic (DMPK) and bioanalytical services for both small and large molecules. Our extensive and diverse industrial experience includes:
It is our goal to help you through the process of taking your drug from pre-clinical/clinical trials to market as fast and as problem-free as possible. We work closely with our clients allowing them full access to data so they feel as if they are walking through their project’s development with us step-by-step.
We share the same level of involvement and commitment as our clients and are dedicated to building a collaboration that enables efficient development of life-changing products while assuring scientific, regulatory and data integrity. Because we invest in each project, we take responsibility and are accountable for the performance and success of our projects.
We fully realize and respect our client’s need for uncompromised regulatory compliance and take every step to ensure that we follow all regulations. Quality is essential to our clients, we are committed to bringing scientific and laboratory excellence to each project we work on.
Early metabolic evaluation has become pivotal for new drug discovery and lead optimization. Alliance Pharma’s staff has decades of experience enabling us to provide complete in vitro and in vivo metabolism data packages for new chemical entities (NCEs), as well as older products requiring updated information. Our laboratories have state-of-the-art instrumentation and our scientist apply the best methodology to provide ADME packages that accelerate drug discovery and optimization time, thereby conserving resources for future clinical development. 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.
Our Drug Metabolism Services include:
Absorption
Distribution
Metabolism
Metabolic Stability in hepatocytes, multi-tissue microsomes, S9 fractions, cytosol and tissue homogenates
Drug – drug interactions between small molecules
Reaction Phenotyping
Metabolite Profiling
GSH Trapping
In vivo PK Analysis
Early metabolic evaluation has become pivotal for new drug discovery and lead optimization. Alliance Pharma’s staff has decades of experience enabling us to provide complete in vitro and in vivo metabolism data packages for new chemical entities (NCEs), as well as older products requiring updated information. Our laboratories have state-of-the-art instrumentation and our scientist apply the best methodology to provide ADME packages that accelerate drug discovery and optimization time, thereby conserving resources for future clinical development. 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.
Our Drug Metabolism Services include:
Absorption
Distribution
Metabolism
Metabolic Stability in hepatocytes, multi-tissue microsomes, S9 fractions, cytosol and tissue homogenates
Drug – drug interactions between small molecules
Reaction Phenotyping
Metabolite Profiling
GSH Trapping
In vivo PK Analysis
Our bioanalytical team offers method development, assay validation and specimen analysis services using state-of-the-art liquid chromatography and mass spectrometry (LC-MS/MS) under non-GLP or GLP regulations. We conduct method validation and sample analysis in compliance with regulatory guidelines to support all stages of pharmaceutical development. Methods are developed and validated in accordance with either client-specific protocols or internal SOPs and all methods are validated to meet MHRA, FDA and/or ICH guidelines.
Our Services include:
Technology Platforms
Our GCLP, GLP and Non-GLP Bioanalysis services for the detection of small or large molecules in a variety of different matrices are performed by:
Technology Platforms
in support of ADME studies, PK/PD, ADA sample and dose analyses.
We provide in vivo pharmacokinetic (PK) screening studies in rodent and non-rodent species and assist in the design of the optimal strategy and protocol to suit any drug discovery program before initiating studies following protocol approval. Dosing and sample collection are followed by LC-MS/MS sample bioanalysis inclusive of PK parameter calculation and report submission.
We utilize a wide variety of dose regimen and administration routes (iv, po, ip, im, in, sc, topical) in the study of mice and rats; while collaborating with partners on studies using other animal species. We employ standardized designs, can draft unique protocols to fit client’s specific requirement and use validated WinNonlin PK software to perform PK data analysis to be included in a full analytical report.
In Vivo PK Studies
We develop and validate immunoassays for large molecules, biotherapeutics and biomarkers to support pre-clinical, clinical and exploratory studies. We transfer and optimize, develop and then validate ligand binding assays to meet the client’s needs under non-GLP and GLP regulations followed by sample analysis.
Biopharmaceutical Services
Technology Platforms
Biomarkers are playing an ever-increasing role in discovery and development of drugs. Our services utilize the latest scientific innovation and state-of-the-art platforms in support of both preclinical and clinical biomarker studies.
Biomarker Services
Technology Platforms
Ligand Binding Assays
Chromatography
We offer single and multi-residue testing for pesticide and herbicide active ingredients in matrices including, but not limited to soil, fruit, grains, dairy products, straw and hay. All agrochemical studies are conducted in compliance with regulatory requirements of the US EPA and the European Commission.
Agrochemical Services
Technology Platforms
Alliance Pharma provides secure and cost-effective biorepository services. Our facility is equipped with state-of-the art technology for sample management and storage.
Sample Storage
We provide short- and long-term storage under monitored conditions at:
for a broad selection of sample types, including:
Drug Discovery & Development Services
Pharmacology Services
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