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Eurofins Bioanalytical Services

St Charles, MO, US

US and UK locations

Eurofins Bioanalytical Services is a powerhouse large molecule biotherapeutic-focused, bioanalytical contract research organization that, since its formation in 2003, has actively supported the evolving needs of companies that develop biotherapeutics.

Our mission is to extend our clients' capabilities by combining scientific knowledge, capacity, regulatory expertise and flexibility to provide the trusted, relevant information required for the drug approval process.

We focus on large molecules in the following areas:

  • Immunogenicity
  • Pharmacokinetic
  • Biomarkers
  • Biosimilars
  • Immunophenotyping

Eurofins Bioanalytical Services has not listed any services.

Preclinical PK/PD Studies
in vivo Pharmacokinetics/Pharmacodynamics
Price on request

Pharmacokinetic /Toxicokinetic (PK/TK) analysis of biopharmaceutical drugs requires different solutions from those traditionally employed in the analysis of small molecules. We have industry-leading experience in the development and validation of PK/TK assays for the measurement of large molecules and... Show more »

Pharmacokinetic /Toxicokinetic (PK/TK) analysis of biopharmaceutical drugs requires different solutions from those traditionally employed in the analysis of small molecules. We have industry-leading experience in the development and validation of PK/TK assays for the measurement of large molecules and peptides.

Pharmacokinetic/Toxicokinetic Analysis Services

When you outsource your PK/TK bioanalysis to Eurofins Bioanalytical Services, you get more than just a service organization: you get access to the top minds in science. We'll deliver the fast, quality results you expect and the insight that comes from years of experience, deep resources and flexible service options. You'll have the support you need for every phase of your project.

Method Transfer

Transfer and optimization of non-validated or validated assays to client specifications

Method Development

To provide the best analytical solution for the broadest range of matrices and species, we:

  • Develop and validate assays that have analytical ranges appropriate for what is expected in the study samples
  • Develop assays that are both specific and sensitive
  • Provide support for adaptation of any commercially available reagents or critical reagent generation and purification including the generation of antibodies to be used for capture or detection reagents
  • Assess method feasibility in multiple technology platforms

Validation

Our comprehensive services follow current FDA guidelines, AAPS white papers and the most up-to-date industry guidelines. We validate as appropriate for the nature of the assay as well as the stage in drug development.

Sample Analysis

From small GLP-compliant pre-clinical projects to large scale GCP-compliant clinical trial sample analysis, our advanced project scheduling and tracking systems offer a scale-flexible outsourcing solution. Studies not requiring GLP/GCP compliance are still performed to the same high standards under our comprehensive quality system.

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Biosimilar Assay Development
Price on request

As patents on many major biologics are expected to expire by 2016, it's estimated that roughly half of the large molecule therapeutics market, representing an estimated $92B in 2010, will be open to competition from large molecule generics, often referred to as biosimilars or follow-on biologics.

Over 50... Show more »

As patents on many major biologics are expected to expire by 2016, it's estimated that roughly half of the large molecule therapeutics market, representing an estimated $92B in 2010, will be open to competition from large molecule generics, often referred to as biosimilars or follow-on biologics.

Over 50 biosimilars/copy-biologics, covering a fairly limited selection of branded drugs, are in the clinic. However, most of these are restricted to emerging markets. Comparatively, only 14 biosimilar approvals have occurred in Europe and none in the United States. It is expected that biosimilar development in these markets will accelerate driven by the emergence of regulatory guidelines, the impending patent cliff and the push for cheaper medications.

Industry Leading Biosimilars Experience

With our regulatory knowledge and experience in product characterization, pharmacokinetics and immunogenicity, for both innovator and biosimilars, we carry your project from Discovery phase through Phase III studies and beyond.

Pre-qualified Assays

  • Trastuzumab
  • Bevacizumab
  • Cetuximab
  • Adalimumab

Biosimilar Assay Development & Testing

A diverse set of methods to evaluate comparability of both the biosimilar drug and it's clinical performance. Eurofins Bioanalytical Services develops customized assays for the comparability testing of biosimilars, exploratory or GLP, including:

  • Clinical Assays
    • PK assay
    • Tiered Immunogenicity (Anti-Drug Antibodies, ADA) testing
    • Nab assays
  • Comparability testing
    • Effector binding Biacore (Surface Plasmon Resonance, Biacore)
      • FcγRI (CD64)
      • FcγRII (CD32a)
      • FcγRIII (CD16a)
      • FcRn
    • C1q binding by ELISA
    • Kinetic binding assays by Biacore
    • ADCC & CDC assays cell-based assays
  • Biosimilars Service Highlights
    • 9 years of bioanalytics experience, including 4 years in biosimilars
    • Regulatory compliant labs in US and EU
    • Experience with monoclonal antibodies, metabolic hormones and immunomodulatory drugs
    • Method transfer / method development & validation / Routine sample analysis
    • Delivery of high quality data suitable for regulatory submission
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Biomarker Analysis
Price on request

Whether your therapeutic focus is diabetes, infection, neurodegenerative disease, osteoporosis, cancer, or other disease states, our biomarker analysis can accelerate your drug discovery and development programs.

We offer consultation and services for proven biomarker assay validation, including Fit-for-Purpose strategies... Show more »

Whether your therapeutic focus is diabetes, infection, neurodegenerative disease, osteoporosis, cancer, or other disease states, our biomarker analysis can accelerate your drug discovery and development programs.

We offer consultation and services for proven biomarker assay validation, including Fit-for-Purpose strategies coupled with GxP compliance. With over 25 years of experience and industry leadership in developing and performing immunoassays on human and animal specimens, we offer proven bioanalytical services for biomarkers - from research to clinical trials and beyond.

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In vitro Immunogenicity Assays
Price on request

The development and validation of immunogenicity assays is under constant discussion within the industry. Our GLP-compliant service laboratories are involved in international workshops and has R&D programs to keep ahead of the latest developments in this area, so that we can best help our customers to accelerate their drug ... Show more »

The development and validation of immunogenicity assays is under constant discussion within the industry. Our GLP-compliant service laboratories are involved in international workshops and has R&D programs to keep ahead of the latest developments in this area, so that we can best help our customers to accelerate their drug discovery and development programs. Adhering to current FDA and EMEA guidelines and AAPS white papers, we follow a stepwise approach to measure ADA responses using ELISA/RIA, surface plasmon resonance (SPR, Biacore®), electrochemiluminescence (ECL), DELFIA and cell-based NAB-assays.

Biopharmaceuticals, such as antibodies, peptides and recombinant proteins, have the potential to induce an anti-drug antibody (ADA) response. The development of ADA can cause allergic or anaphylactic reactions, reduction in efficacy, or induction of autoimmunity.

Factors affecting immunogenicity include:

  • Similarity to self proteins
  • Glycosylation status
  • Excipients
  • Route of administration
  • Dosing schedule
  • Target

In non-clinical studies, development of ADA can affect drug exposure and impact on data from toxicity, pharmacokinetic (PK) or pharmacodynamic (PD) studies. In clinical studies, development of ADA can be associated with a variety of potentially serious clinical side effects as well as a loss of drug efficacy. Adhering to current FDA and EMEA guidelines and AAPS white papers, we follow a stepwise approach to measure ADA responses using a variety of leading instrumentation platforms.

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Immunoassays
Price on request
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Pharmacology & Toxicology
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Bioanalysis
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Biomarkers
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Bioavailability Studies
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ADME and DMPK Studies
Drug Metabolism and Pharmacokinetics
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