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Covance - Analytical Solutions

Princeton, New Jersey, US

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

Covance - Analytical Solutions has not listed any services.

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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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Drug Safety and Toxicology
Toxicology
Bioanalytical Assays
Price on request

Large and small molecule bioanalytical testing

Large and small molecule bioanalytical testing

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Small 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 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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GLP
Biomarker discovery
LC-MS
Chiral Drug Assays
PK/PD
TK
Dried Matrix Spot Analysis
Bioavailability Studies
Bioequivalence Studies
Allometric Scaling
WinNonlin
SAS
NONMEM
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.

*... 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 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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GLP
LC-MS
PK/PD
TK
Bioavailability Studies
Bioequivalence Studies
WinNonlin
SAS
NONMEM
PK
Immunogenicity Studies
Neutralizing Antibody Detection
Titer Assessment
allo
Preclinical PK/PD Studies
in vivo Pharmacokinetics/Pharmacodynamics
Price on request
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Rabbit
Mouse
Rat
PK/PD
Drug Safety and Toxicology
Non-human primates
Toxicology
Canine
Clinical PK/PD Studies
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PK/PD
Drug Safety and Toxicology
PK/PD Modeling
Pharmacokinetics/Pharmacodynamics Modeling
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PK/PD
In vivo Immunogenicity Assays
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Mouse
Rat
Drug Safety and Toxicology
Non-human primates
Canine
In vivo Biologic & Biosimilar Toxicity Screening
Price on request
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Rabbit
Mouse
Rat
Drug Safety and Toxicology
Non-human primates
Toxicology
Canine
Biologic Fingerprinting
Price on request

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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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
Non-human primates
Canine
Project and Process Management
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In vivo Toxicity Testing
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Mouse
Rat
Non-human primates
Canine
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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2018-02-08 20:06:08 +1300

Net Promoter Score of 10 received for Archive Management.

Additional Ratings: satisfaction with deliverable: 10, satisfaction with timeliness: 10.

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