Eurofins Pharma Bioanalytical Services

We offer bioanalytical support for every stage of large molecule drug development process through phase I, II, III and IV to the pharmaceutical and biopharmaceutical companies of all sizes.

Our analytical platforms include ELISA, MSD-Electrochemiluminescence and multiplexing capabilities and focus on bioanalytical studies for monoclonal antibodies, proteins, conjugated proteins and peptides.

Our GLP-compliant Bioanalytcal Immunochemistry Laboratory services include:
• Pharmacokinetic (PK) bioanalysis
• Toxicokinetic (TK) studies
• Immunogenecity testing
• PD bioanalysis (biomarkers)
• Method transfer
• Method development
• Method optimization
• Method validation
• Routine Testing
• Quantitative and Qualitative immunoassays
• GLP and non-GLP Immunoassays to support clinical and pre-clinical studies
Our laboratories use Watson LIMS for sample handling and tracking.

Your Project will benefit from our expertise

Because the uses for biomarkers are quite diverse, they require a contract laboratory partner with a breadth of specialty expertise. Eurofins Bioanalytical has unmatched experience in assay development, validation and analysis.

Whether your therapeutic focus is metabolism, neurodegenerative disease, osteoporosis, immuno oncology, or infectious disease, successful programs depend upon precise biomarker evaluation. Our experience has taught us that no one platform can adequately address all biomarker needs and the use of diverse platforms such as: RIA, Gyros™, Luminex®, MSD® and Singulex® is required to quantitative assess soluble biomarkers.

Through partnering with Eurofins Bioanalytics you can be assured that we will apply the optimal solution to address your needs.

With over 15 years of experience consulting, developing and performing Fit-for-Purpose immunoassays in both pre-clinical and clinical studies we have proven expertise.

Let our experience guide you.

Exploratory Biomarker Services

Whether it is a Customized or commercially available immunoassay kits, the pharmaceutical and biotechnology industries are faced with various challenges in developing new and innovative medical products, including increased drug development costs, decreasing rate of drug approvals by the FDA .

Developing novel biomarker assays requires a great deal of time, a high level of expertise, and often comes at an incredibly high expense. These factors have contributed to the growing popularity of commercial immunoassay kits. Commercially available biomarker assay kits are a less resource-intensive alternative to support drug development programs at a lower price point. These kits also offer the benefits of portability, expedited analytical solutions, and in most cases, ease of operation

Fit-for-Purpose Biomarker Services

We offer consultation and services for proven biomarker assay validation, including Fit-for-Purpose strategies coupled with full GxP compliance. With unsurpassed experience and following the current industry guidelines, Eurofins Bioanalytical Services provides the technical expertise, quality assurance and peace of mind essential when considering an outsourcing partner for preclinical through clinical regulated sample analysis.

Validated Biomarker Services

Validation of analytical methods is crucial in generating data to be used in support of regulatory submissions. Following the most up-to-date industry guidelines, we offer a fully consultative and comprehensive assay validation or cross-validation service. We validate using a fit-for-purpose approach as appropriate for the nature of the assay as well as the stage in drug development.

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

Eurofins Bioanalytical Services offers a comprehensive suite of capabilities to match any scale of immunogenicity project.

Method Transfer

Transfer and optimization of non-validated or validated client-developed assays.

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

Validation of analytical methods is crucial in generating data to be used in support of regulatory submissions. Following the most up-to-date industry guidelines, we offer a fully consultative and comprehensive assay validation or cross-validation service. We validate using a fit-for-purpose approach as appropriate for the nature of the assay well as the stage in drug development.

Sample Analysis

Using the latest industry guidance we apply a tiered immunogenicity testing methodology accompanied with statistical data analysis & support. The steps we use to measure ADA are:
•Screening assay
•Confirmatory assay
•Neutralization assay
•Characterization assays (isotype, affinity, etc.)

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.

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
    

• Immunophenotyping- study of proteins expressed by cells
  
• Ligand occupancy (saturation / modulation)
  
• Cellular activation
  
• Toxicity (ROS)
  
• Cell proliferation (CountBright Beads)
  
• Intracellular antigens/ cytokines
  
• Autophagy (LC3b monitoring)
  
• Phosphorylation of proteins
  
• Transfection validation / subclone selection
  
• Antigen specific cells
  
• Intracellular Signaling
  
• Cell Death (PI, SYTOX® Dead Cell Stains from Invitrogen)
  
• Apoptosis (Annexins, Bcl-2 and Caspase)
  
• CTL (Cytotoxic T-Cell identification and signaling)
  
• Flow/Nab

Need to develop a specific, sensitive, validated assay for the most informative, predictive, relevant biomarkers for your system? We develop reliable, custom assays to serve customers conducting protein research.

Custom Assay Development Capabilities:

•Reagents ◦Immunogen design
◦Antibody development

•Assay Development ◦Research
◦Investigational
◦IVD validation

•Manufacturing ◦Commercial kits for RUO

•Analytical testing services ◦Non-regulated
◦Regulated
◦GMP support

Custom Assay Development Team Attributes:
•Expertise: 25+ years of experience in immunoassay development, including multiplex assays using Luminex® xMAP® technology
•Knowledge: in-depth knowledge of research areas supported by our extensive portfolio of assays
•Capabilities: full spectrum of capabilities including antibody development, custom manufacturing and bioanalytical testing services
•Flexibility:multiple platforms - customization to suit your needs, from research to GxP compliance ◦ELISA/RIA, Luminex® xMAP® technology, Flow Cytometry, Gyrolab®, Electrochemiluminescence (ECL)

•Manufacturing capabilities*
◦Research reagents and kits (RUO)
◦IVD manufactured assays
◦Diagnostic reagents
•Analytical testing services
◦Extensive quality management
◦GLP/GCP/GMP compliant
◦21 CFR Part 11 compliant electronic applications

*not all platforms are available in manufactured kit format and regulated products.

Our expertise spans many different therapeutic areas and applications, including:

•Cancer
•Cardiovascular
•Cell Signaling
•Cellular Metabolism
•Immunology
•Metabolism & Endocrinology
•Neuroscience
•Stem Cells
•Toxicity

REGULATORY / DATA SERVICES
•Conduct pre-qualification / due diligence, GLP and OECD audits
•Monitor and track ongoing bioanalytical activities at a sponsor partner
•Perform post study data audits
•Perform critical review of method validation and sample analysis data and reports
•Develop, review and revise SOPs and laboratory processes
•Prepare and review study reports and manuscripts
•Develop and present regulatory training programs

SCIENTIFIC / TECHNICAL SERVICES
•Method transfers and partial validations
•Develop and implement method development strategies
•Provide remote or on-site bioanalytical expertise to US and International Clients
•Determine the root cause for assay issues observed during method development, method validation and identify suitable solutions
•Identify and minimize matrix effect issues
•Evaluate, recommend and implement strategies for new technologies
•Review and critique assay methodology and validation data
•Develop and present targeted scientific seminars and training programs

Cytokine release syndrome (CRS) is an adverse event on administration of biotherapeutics, typified by the production of pro-inflammatory cytokines, including TNFα, IFNγ, IL-6 etc.

It causes "flu-like" symptoms, including pyrexia, nausea, rigors, but can be more severe with capillary leak syndrome resulting in hypotension and organ damage.

The most severe example in recent years was with the CD8 super-agonist TGN1412.
Drug companies should evaluate cytokine release if

increasing importance of testing
The only regulatory CRS guidance comes from an EMA sponsored meeting; stresses the importance of CRS for immune-active products, design to be relevant to MoA, methods to be ‘suitably validated’
Positive CRS is information, not a stop signal

SCIENTIFIC / TECHNICAL SERVICES
•Method transfers and partial validations
•Develop and implement method development strategies
•Provide remote or on-site bioanalytical expertise to US and International Clients
•Determine the root cause for assay issues observed during method development, method validation and identify suitable solutions
•Identify and minimize matrix effect issues
•Evaluate, recommend and implement strategies for new technologies
•Review and critique assay methodology and validation data
•Develop and present targeted scientific seminars and training programs

REGULATORY / DATA SERVICES
•Conduct pre-qualification / due diligence, GLP and OECD audits
•Monitor and track ongoing bioanalytical activities at a sponsor partner
•Perform post study data audits
•Perform critical review of method validation and sample analysis data and reports
•Develop, review and revise SOPs and laboratory processes
•Prepare and review study reports and manuscripts
•Develop and present regulatory training programs

SCIENTIFIC AND BUSINESS PROCESS SERVICES
•Aid start-up, small and virtual companies to assess or build bioanalytical expertise
•Review bioanalytical and site policies and procedures
•Review contracts, method development and sample analysis study plans and protocols
•Prepare method development strategies to streamline method development processes
•Prepare method development plans for specific drug candidates
•Prepare templates for proposals, work plans and reports

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.

Regulatory Review, Certification and Product Registration Services

Business Operations and Logistics Support Services