Wieslab Bioanalytical and Cell-Based Services for Clinical Trials
Wieslab, a Svar Life science company, is a contract laboratory that offers large molecule bioanalytical services to support drug development projects.
The company specialises in pharmacokinetics (PK), immunogenicity, biomarker and cell-based services for clinical applications ranging from pre-clinical to Phase I-III trials.
Wieslab has direct access to state-of-the-art iLite® technology, which is based upon reporter-gene cell-based assays. This is used to assess neutralising antibodies.
Wieslab works within oncology and immune-mediated drug development projects. Its laboratory meets good clinical practice (GCP), good laboratory practice (GLP) and ISO: 17025 requirements, and its staff are experienced at working in regulated environments.
Developing, optimising and validating sensitive and robust immunoassays
Wieslab develops immunoassays for regulated studies and overcomes issues through a structured approach to assay development.
With more than 25 years of experience in developing, optimising and running immunoassays, the company provides sensitive and robust assays that perform throughout its clients’ studies.
Wieslab provides a wide range of immunoassays, including enzyme-linked immunosorbent assay (ELISA), mesoscale discovery (MSD), and cell-based assays. Its service features method development, sample analysis, optimisation and validation, which are all performed in a laboratory information management system (LIMS) environment.
Pharmacokinetic testing to increase drug efficacy
Understanding the pharmacokinetic (PK) behaviour of a drug helps in designing the dose, route and schedule of administration to maximise effectiveness while reducing adverse effects.
Wieslab is an expert in bioanalysis for PK testing of large molecules. It consults clients and professionals working with PK / pharmacodynamics on the appropriate analytical approach for pre-clinical and clinical studies.
Ligand Binding Assays (LBA) are used for bioanalytical assays to determine drug concentration in biological matrices. Wieslab‘s scientists use ELISA or electrochemiluminescence assays to perform PK testing.
Immunogenicity testing to measure ADAs and NAbs
Specific and sensitive assays are required for the detection and characterisation of anti-drug antibodies (ADA). High-quality ADA data enables the assessment of the impact of ADAs on key drug parameters such as pharmacokinetic profile, safety and efficacy.
Wieslab is experienced within immunogenicity assessment of large molecules, including biologics and biosimilars. The company has access to a range of immunogenicity assays for detection of immune responses in pre-clinical and clinical studies.
Successful assays are dependent on the use of quality critical reagents. Wieslab offers labelling for antibody reagents, antibody purification and oversight of positive antibody control generation.
Immunogenicity is measured in a multi-tiered approach using screening and confirmatory assays to determine antibody drug specificity. Confirmed drug-specific antibody samples are further quantified in a titration assay and characterised for their neutralising binding capability (NAb assay).
Wieslab unique access to the iLite® technology platform allows flexible, accurate and precise assessment of NAbs.
Biomarker services using ELISA or electrochemiluminescence
Wieslab provides custom and kit-based services for quantifying cytokines, chemokines and other biomarkers in animal or human matrices.
Its scientists use ELISA or electrochemiluminescence, as well as offer in-house assay development, qualification and validation.
Stable recombinant cell lines are used in a variety research and drug development activities such as discovery, profiling, neutralisation antibody assessments, potency testing and other functional evaluations.
Through its parent company Svar Life Science, Wieslab offers custom cell line development services utilising innovative iLite® technology platform, where the cell lines are engineered using target-specific reporter gene constructs. The custom cell line is extensively validated and supplied as ready-to-use cells.
Project management services
Wieslab utilises a transparent direct partnering model for all projects, assigning clients with a single point of contact who will communicate on a timely basis and make sure requirements and oversight needs are met throughout the entire project lifecycle.
Experienced and flexible staff
The scientific knowledge of Wieslab’s staff makes a key difference to its client’s projects. More than 50% have a Doctorate (PhD), and the company works to stay up-to-date with the latest regulatory guidelines and scientific development.
The majority of the company personnel has worked within the pharmaceutical or biotech industries, with experience in delivering high-quality data and working according to applicable guidelines and regulations.
Wieslab has a flexible team of scientists that work closely with sponsors to adapt to changing requirements and to speed up the development process.