We help accelerate and optimize your drug development programs 

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Wieslab Bioanalytical Services

Delivers bioanalytical excellence through a collaborative approach

Our bioanalytical services are centered on large molecules (biologics and biosimilars) with a focus on immune-mediated diseases, providing services for non-clinical as well as Phase I - III and post-marketing clinical studies for pharma, CRO and biotech clients.

Our offering consists of:

  • Biomarker studies
  • Bioanalysis – pharmacokinetic (PK) studies
  • CMC support (potency assays - non GMP)
  • Consultant services to optimize your study's assay strategy and improve submission success
  • Anti-drug antibody (ADA) and Neutralizing antibody (NAb) testing in immunogenicity studies
  • Cell-Based Neutralization Assays

Bioanalytical Service Areas

With more than 250 immunology markers in our testing portfolio including complement and RIA markers we have the flexibility to adapt to many different studies. We can also develop ligand-binding assays (LBA) for safety assessments, or to determine the mechanism of action of drug leads. 

Access to a Range of Technologies

By offering a wide range of technology platforms such as MSD, ELISA, RIA and the cell-based iLite® technology platform we´re able to offer a range of immunoassays in our GLP and GCP-compliant bioanalytical laboratory.

We Answer to Your Needs

Our Bioanalytical Services can make a difference in your drug development project. Benefits of using our bioanalytical laboratory & CRO services are:

  • We work according to ISO 17025 and Good Laboratory Practices (GLP)
  • We are Good Clinical Practices (GCP) compliant
  • We support clinical as well as pre-clinical studies
  • We offer bioanalysis of biologics and biosimilars
  • We perform biomarkers measurement services
  • We offer in a multi-tiered approach to measure ADAs and NAbs

Our scientists are are highly trained and experienced in:

  • developing and validating immunoassays
  • various different technologies and methods

Bioanalytical Quality Assurance

High quality standards and processes are essential when working in bioanalytical projects. Our GCP, GLP, and ISO 17025 compliant laboratory is managed and staffed by scientists with significant experience in regulated environments.

Oour scientists have long experience meeting guidelines from the EMA and the FDA. 
Our goal is to provide key knowledge and analytical results to help our clients accelerate their drug discovery and development programs.

Our Expertise

You can use our bioanalytical services for method development/transfer, validation and samples analysis to generate data on, for example, pre-existing or auto-antibodies in a disease population. Other areas of expertise are:

  • Biomarker studies
  • Bioanalysis – pharmacokinetic (PK) studies
  • CMC support (potency assays - non GMP)
  • Consultant services to optimize your study's assay strategy and improve submission success
  • Anti-drug antibody (ADA) and Neutralizing antibody (NAb) testing in immunogenicity studies
  • Cell-Based Neutralization Assays