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Covance - Analytical Solutions

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Princeton, New Jersey, US

About Covance - Analytical Solutions

Divison of: Covance

Gain Strength in Depth.

From preclinical research through clinical development you can get accurate, on-time results at every stage of the continuum to advance your program. Leverage our expert scientific team, state-of-the-art technologies and global resources to deliver high-quality results.

*... Show more »

Gain Strength in Depth.

From preclinical research through clinical development you can get accurate, on-time results at every stage of the continuum to advance your program. Leverage our expert scientific team, state-of-the-art technologies and global resources to deliver high-quality results.

  • Bioanalytical – Small Molecule
  • Bioanalytical – Biologics
  • Preclinical and Clinical PK/PD Studies
  • Biologics Fingerprinting, Potency, QC & Safety
  • Inhalation product testing
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Certifications & Qualifications

GLP

Our Services (40)


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IND-Enabling Studies

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In vivo Biologic Potency Testing

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In vitro Biologic & Biosimilar Toxicity Screening

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Archive Management

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Adventitious Agent Testing

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In vitro Biosafety Testing

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  • Biologics Safety Testing:
    • Trace analysis: residual HCP, Pro A, Insulin
    • Trace analysis: residual DNA
    • Sterility
    • Endotoxin
    • Sub-visible particles
    • Residual antibiotics
    • Excipient
    • Residual methionine sulphoximine
    • Mycoplasma detection assays
    • in vitro adventitious virus screens
    • Virus identification
  • Biologics Safety Testing:
    • Trace analysis: residual HCP, Pro A, Insulin
    • Trace analysis: residual DNA
    • Sterility
    • Endotoxin
    • Sub-visible particles
    • Residual antibiotics
    • Excipient
    • Residual methionine sulphoximine
    • Mycoplasma detection assays
    • in vitro adventitious virus screens
    • Virus identification
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Toxicology

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Bioanalytical Assays

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Large and small molecule bioanalytical testing

Large and small molecule bioanalytical testing

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Small Molecule Bioanalysis

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Meet your program’s requirements while complying with FDA Crystal City and current regulatory guidelines. Put the #1 ranked bioanalysis service provider to work on your drug development effort, backed by a team that develops 600+ methods and completes 1,400+ studies comprised of 950,000+ samples annually for small molecule... Show more »

Meet your program’s requirements while complying with FDA Crystal City and current regulatory guidelines. Put the #1 ranked bioanalysis service provider to work on your drug development effort, backed by a team that develops 600+ methods and completes 1,400+ studies comprised of 950,000+ samples annually for small molecule programs.

Small Molecule Bioanalytical Services:

  • Method feasibility, development, transfer, validation and sample analysis (GLP/GCP)
  • Specialized LC-MS Solutions, including High-Resolution Accurate Mass spectrometry
  • Dried Matrix Spot analysis and liquid microsampling
  • Discovery bioanalysis (non-GLP)
  • Chiral drug assays
  • Nonclinical toxicokinetic (TK) and pharmacokinetic (PK) studies
  • Clinical PK, bioavailability & bioequivalence studies
  • Nonclinical and clinical drug/drug interaction studies
  • Nonclinical and clinical pharmacodynamics (PD) studies
  • Pharmacokinetics/pharmacodynamics and toxicokinetics analysis
    • Compartmental and noncompartmental analysis (WinNonlin™)
    • PK/PD Modeling and simulation
    • Population pharmacokinetics (NONMEM®)
    • PK/PD analysis
    • Statistical analysis (SAS®)
    • Prediction of human PK using allometric scaling and in vitro scale-up
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WinNonlin SAS NONMEM GLP Biomarker discovery LC-MS Chiral Drug Assays PK/PD TK Dried Matrix Spot Analysis Bioavailability Studies Bioequivalence Studies Show 12 more tags Show less

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Large Molecule Bioanalysis

Price on request

Meet your program’s requirements while complying with FDA Crystal City and current regulatory guidelines. Put the #1 ranked bioanalysis service provider to work on your drug development effort, backed by a team that develops 150+ methods and completes ~300 studies comprised of 350,000+ samples annually for biologics programs.

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Meet your program’s requirements while complying with FDA Crystal City and current regulatory guidelines. Put the #1 ranked bioanalysis service provider to work on your drug development effort, backed by a team that develops 150+ methods and completes ~300 studies comprised of 350,000+ samples annually for biologics programs.

  • Method feasibility, development, transfer, validation and sample analysis (GLP/GCP)
  • Specialized LC-MS Solutions, including High-Resolution Accurate Mass spectrometry
  • Discovery bioanalysis (non-GLP)
  • Immunogenicity studies using a tiered approach:

    • Screening
    • Confirmatory (immunodepletion)
    • Titer assessment (quantification, semi-quantification)
    • Cell-based neutralizing antibody detection
    • Vaccine support with Biosafety Level 3 capabilities
  • Nonclinical toxicokinetic (TK) and pharmacokinetic (PK) studies

  • Clinical PK, bioavailability & bioequivalence studies

  • Nonclinical and clinical drug/drug interaction studies

  • Nonclinical and clinical pharmacodynamics (PD) studies

  • Pharmacokinetics/pharmacodynamics and toxicokinetics analysis

    • Compartmental and noncompartmental analysis (WinNonlin™)
    • PK/PD Modeling and simulation
    • Population pharmacokinetics (NONMEM®)
    • PK/PD analysis
    • Statistical analysis (SAS®)
    • Prediction of human PK using allometric scaling and in vitro scale-up
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WinNonlin SAS NONMEM GLP LC-MS PK/PD TK Bioavailability Studies Bioequivalence Studies PK Immunogenicity Studies Neutralizing Antibody Detection Titer Assessment Show 13 more tags Show less

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In vivo PK/PD Studies

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Rabbit Mouse Rat Dog Non-human primates (NHP) PK/PD Toxicology Show 7 more tags Show less

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Clinical PK/PD Studies

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PK/PD Toxicology

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PBPK Modeling

In silico absorption, distribution, metabolism, and excretion
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PK/PD

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In vivo Immunogenicity Assays

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Mouse Rat Dog Non-human primates (NHP) Toxicology

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In vivo Biologic & Biosimilar Toxicity Screening

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Rabbit Mouse Rat Dog Non-human primates (NHP) Toxicology Show 6 more tags Show less

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Biologic Fingerprinting

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Biologics Identity Assessment/Fingerprinting:

  • N-terminal Sequencing(Primary)
  • AAA(Primary)
  • Peptide Map(Primary)
  • Intact Mass
  • Circular Dichroisim (secondary and tertiary)
  • Western Blot
  • Glycosylation(N-linked, O-linked, sialic acid, total sugars)
  • Cell-based identification
  • in vivo identification
  • Identification by HPLC
  • Miscellaneous tests

Biologics Identity Assessment/Fingerprinting:

  • N-terminal Sequencing(Primary)
  • AAA(Primary)
  • Peptide Map(Primary)
  • Intact Mass
  • Circular Dichroisim (secondary and tertiary)
  • Western Blot
  • Glycosylation(N-linked, O-linked, sialic acid, total sugars)
  • Cell-based identification
  • in vivo identification
  • Identification by HPLC
  • Miscellaneous tests
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In vitro Biologic Potency Testing

Price on request

Biologics Strength/Potency Determination:

  • Concentration
  • Cell-based bioassays
  • in vivo bioassays

Biologics Strength/Potency Determination:

  • Concentration
  • Cell-based bioassays
  • in vivo bioassays
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Biopharmaceutical Characterization

Price on request
  • Biologics Purity Assessment

    • Charge Heterogeneity
    • Size Heterogeneity
    • Deamidation and Oxidation
    • Glycosylation(N-linked, O-linked, sialic acid, total sugars)
    • N-terminal Sequencing
    • Dynamic Light Scattering
    • Water content
  • Biologics Quality Testing

  • Biologics Purity Assessment

    • Charge Heterogeneity
    • Size Heterogeneity
    • Deamidation and Oxidation
    • Glycosylation(N-linked, O-linked, sialic acid, total sugars)
    • N-terminal Sequencing
    • Dynamic Light Scattering
    • Water content
  • Biologics Quality Testing

    • GMP and non-GMP Stability & Release
    • Accelerated and forced degradation studies
    • Specialized conditions (UV, oxidizing, high temperature, pH)
    • Selection of stability indicating techniques
    • Short and long-term studies
    • Materials compatibility
    • Shipping validation
    • Freeze/thaw studies
    • Temperature cycling
    • Formulation analysis
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Residual Impurity Analysis

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Inhalation Product Testing

Price on request

Small Molecule Performance Testing of Inhaled Products:

  • Particle size characterization (NGI and ACI)
  • Dose content uniformity
  • Patient simulation use testing
  • Moisture analysis
  • Assay/degradation
  • Foil integrity testing
  • Leak rate testing

Small Molecule Performance Testing of Inhaled Products:

  • Particle size characterization (NGI and ACI)
  • Dose content uniformity
  • Patient simulation use testing
  • Moisture analysis
  • Assay/degradation
  • Foil integrity testing
  • Leak rate testing
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Extractable and Leachable Testing

Price on request

Small Molecule Extractable and Leachable Testing:

  • Inhaled and non-inhaled products
  • Lacquers
  • Plastics
  • Ink and dyes
  • Valve components
  • Closures
  • Containers

Small Molecule Extractable and Leachable Testing:

  • Inhaled and non-inhaled products
  • Lacquers
  • Plastics
  • Ink and dyes
  • Valve components
  • Closures
  • Containers
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Immunoassays

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Clinical Trials, Consulting, and Management

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Formulation Services

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Toxicology

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Rabbit Mouse Rat Dog Non-human primates (NHP)

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Project Management

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In vivo Toxicity Testing

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Mouse Rat Dog Non-human primates (NHP)

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Product Quality Control

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Chemistry and Materials

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Bioanalysis

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Product Development, Testing, and Packaging

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Pharmacology & Toxicology

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Manufacturing Services

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Drug Development

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Clinical Research

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Analytical Chemistry Services

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Drug Discovery & Development

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In vitro Toxicity Testing

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In vitro Toxicity Testing Services

In vitro Toxicity Testing Services

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Pharmacology

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Pharmacology Services

Pharmacology Services

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In vivo Pharmacology Studies

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In vivo Pharmacology Studies Services

In vivo Pharmacology Studies Services

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