Alliance Pharma

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

• Passive Permeability in MDCK cells
  
• Active Permeability in MDCK-MDR1 (P-gp) and CaCo-2 (P-gp and BCRP) cells
  

Distribution

• Protein binding in plasma, whole blood, microsomes, tissue homogenate (mouse, rat, dog, monkey human etc.)
  
• Rapid Equilibrium Dialysis (RED) or Ultracentrifugation
  
• Red Blood Cell Partitioning in whole blood
  
• Plasma stability (mouse, rat, dog, monkey human etc.)
  

Metabolism

• Metabolic Stability in hepatocytes, multi-tissue microsomes, S9 fractions, cytosol and tissue homogenates
  

• Drug – drug interactions between small molecules

  • Direct and Mechanism-Based Inhibition
    
  • CYP450 Induction
    

• 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:

• 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
  

Technology Platforms

• HPLC-UV/Visible
  
• LC-MS and LC-MS/MS (Sciex API 4000 and 5500)
  

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

• LC-MS/MS for small molecules
  
• ELISA, MSD or Gyros Lab for large molecules
  

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

• Dosing and sampling from mice and rats
  
• In-life study collaboration with partners using other animal species
  
• Sample bioanalysis under GLP (Tox study) or non-GLP (discovery PK)
  
• PK parameter calculation
  
• Documentation for IND filing
  

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

• Method Development, Validation and Sample Analysis for Large Molecules
  
• Immunoassays for PK/TK Studies
  
• Immunogenicity Assays (screening, confirmation, titration and nAb determination)
  
• Cell-based Bioassays (potency, cytotoxicity, genotoxicity and reporter gene assay)
  
• RNAi, Genotyping, Gene Expression, Mutation and Methylation
  

Technology Platforms

• ELISA, MSD, Gyros
  
• Single and Multiplexing
  
• Chromogenic
  
• Fluorescence
  
• Lumininescence
  
• Electrochemiluminescence (ECL)
  

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

• Custom method development and assay validation
  
• Transfer of Proprietary Assays
  
• Commercial Kit Qualification
  

Technology Platforms

• Ligand Binding Assays

  • ELISA, MSD, Gyros
    
  • Cell Based Assays
    

• Chromatography

  • LC-MS/MS (Sciex API 4000 and 5500)

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

• Analytical Method Development
  
• Independent Laboratory Validation
  
• Pesticide Residue Analysis
  
• Formulation Analysis
  

Technology Platforms

• HPLC-UV/Visible
  
• LC-MS and LC-MS/MS (Sciex API 4000 and 5500)

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:

• Ambient
  
• Cold storage (4°C and -20°C)
  
• Ultra low-temperature storage (-70°C, -80°C )
  
• Liquid nitrogen storage (-196°C)
  

for a broad selection of sample types, including:

• Active Pharmaceutical Ingredients (API)
  
• Agrochemical and Plant Samples
  
• Animal Samples
  
• Antibodies
  
• Biological Fluids – urine, serum, plasma, whole blood
  
• Biomarker Samples
  
• Clinical & Pre-Clinical Trial Material (Phases I, II, III, IV)
  
• Clinical Drug Products
  
• Tissue and Cell Lines
  
• Veterinary Materials
  
• Other Biological Materials