Bioanalytical Services

Toxicology is the branch of pharmacology that studies the behavior and effects of compounds at very high doses in an organism. The goal of toxicokinetic (TK) studies is to determine the exposure levels at which toxic effects are observed, and results are used to guide dosing recommendations for clinical testing.

We conduct TK analysis in strict compliance with GLP regulations and in accordance with international regulatory guidelines (FDA, EMEA, ICH).

Instrumentation:

• ELISA
• MSD^®-ECL
• LC-MS/MS

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Pharmacokinetics (PK) reveals how a therapy moves through the body—from absorption and distribution to metabolism and excretion—and translates those dynamics into actionable decisions for development.

In the drug development process, robust PK data underpins dose selection, route and frequency of administration, and the transition from preclinical models to first-in-human and late-stage trials.

We deliver end-to-end PK support across drug modalities at any phase of development, combining deep bioanalytical experience with regulatory expectations.

Instrumentation:

• ELISA
• MSD^®-ECL
• LC-MS/MS

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Pharmacodynamics studies focus on the biochemical and physiological effects of the drug on the patient and are crucial to ensure a complete understanding of the therapeutic product.

Large molecule PD bioanalysis provides insights into the mechanism of action and how the drug works on a biochemical level. PD bioanalytical studies can be used to investigate what molecules bind, how the targets are inhibited, what signaling pathway is affected, and to identify downstream effects.

Instrumentation:

• ELISA
• MSD^®-ECL
• Cell-based assays
• LC-MS/MS

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Immunogenicity is a critical factor in drug development., as unwanted immune responses, from minimal effects to severe and life-threatening reactions, can impact both safety and efficacy. Regulatory guidelines require thorough evaluation of immunogenicity for biologics and biosimilars.

With extensive experience, we offer a multi-tiered approach using advanced assays to detect and confirm anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) across preclinical and clinical studies.

Instrumentation

• ELISA
• MSD^®-ECL
• Cell-based assays

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In drug development, biomarker analysis supports the assessment of candidate drugs. Biomarkers can be used to validate targets, prove mechanisms of action, predict efficacy, and find potential toxicity, enabling go/no-go decisions during the drug development process.

We offer a complete biomarker service tailored to your drug development project. Our approach ensures that every assay is developed with a clear context of use and is fit-for-purpose, providing reliable data to support decision-making at each stage. 

Instrumentation:

• ELISA
• MSD^®-ECL
• SIMOA^®
• LC-MS/MS
• Cell-based assays

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Through Svar Wieslab Diagnostic Service, we offer a comprehensive range of individual tests and test panels that support clinical testing and therapeutic drug monitoring.

With flexible, tailored diagnostics and responsive service, Svar Wieslab combines clinical expertise and ISO 15189-certified rigor to deliver timely and accurate results.

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We offer expert consulting for large molecule preclinical and clinical studies, helping you design optimal bioanalytical strategies to accelerate drug discovery and development. Our scientist-to-scientist approach ensures tailored solutions for your toughest assay challenges. By understanding your molecular targets, pharmacokinetics, and lead molecules, we identify risks and opportunities to drive improvement.

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