Find out how we can be the right partner for your bioanalytical service needs

Bioanalytical Service Areas

Why Partner with us?

As a specialist bioanalytical service laboratory, Wieslab Bioanalytical Services is able to offer a flexible experienced team that adapts to the customers’ needs. Our experienced team of bioanalytical scientists work according to a clear understanding of customer needs and requirements. We´re known for our customer focused approach and work according to GLP and GCP where applicable to always ensure that regulatory requirements are met. 

Our goal is to provide key knowledge and analytical results to help our clients accelerate their drug discovery and development programs. 

Our range of versatile solutions can help you to:

  • Save time during identification of biomarkers undertaking patient stratification and monitoring

  • Optimize the clinical trial process by involving fewer patients, with clearer endpoints and easier result interpretation

  • Get support in all phases of drug development

Many of our scientists have worked in large pharma companies and they all have many years of experience in delivering high quality data, working according to applicable guidelines and regulations.

Main areas of expertise

Wieslab Bioanalytical Services offer assay & method development and transfer, validation and sample analysis with a focus on biologics and biosimilars in pre-clinical and clinical studies.

  • Method transfer - transfer and optimization of non-validated or validated assays to client specifications

  • Assay/Method development – development of assays from scratch, or adaptation of any commercially available assay kit. We also offer optimization services of customers assays

  • Validation - validation of assays following relevant guidelines and white papers. Assays are always validated using a "fit for purpose" approach

  • Sample analysis - from one plate, or a pre-clinical study to Phase III clinical trial projects and post-marketing. Wieslab Bioanalytical Services can handle variable sample numbers and large volumes to meet the needs of our clients.

Our Range of Bioanalytical Services

Immunogenicity Testing

With several years of experience within immunogenicity assessment of large molecules (Biologics and Biosimilars) we have access to a range of immunogenicity assays for detection and confirmation of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) supporting pre-clinical and clinical studies.

Complement Assessment

Assessment of complement function and individual complement components are valuable in a number of application areas. We use the Svar Life Science test solution for functional assessment of the entire complement system including all three pathways.

Pharmacokinetic (PK) Testing

We offer expertise in bioanalysis for PK testing of large molecules. We consult with clients, as well as experts in Pharmacokinetics and Pharmacodynamics, on the appropriate analytical approach for pre-clinical and clinical studies.

Biomarkers

We offer custom and kit-based services for quantifying cytokines, chemokines, and other biomarkers in animal or human matrices. Our scientists use ELISA, RIA or Electrochemiluminescence (ECL)-based assays to perform the biomarker work.

Potency assays - lot release: Biopharma product testing

In order to meet the regulatory requirements for the release of biological drugs into the market, biological potency assays are of vital importance for product development and manufacturing processes. 

Our biological potency assays are based on the unique iLite® technology and offers key tools to help meet these requirements. Our service offerings include testing of drug substances, final product, intermediates, and starting materials for large molecule drug products. In addition, we have a range of potency assays that can be applied.