As your clinical development progresses, precise, data-driven insights become essential. At FyoniBio, we offer more than routine bioanalytical testing—we partner with you to design, develop, and validate tailored assay strategies that align with your molecule, study design, and regulatory requirements.
We specialize in pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity bioanalysis for a wide range of biotherapeutics, from small oligonucleotides to large proteins. Every assay is developed with your clinical objectives in mind, ensuring relevance, reproducibility, and regulatory readiness. In collaboration with BioGenes, we also offer custom generation of monoclonal and polyclonal antibodies.
Therapeutics with multiple functional domains, such as bispecific antibodies, fusion proteins, or antibody-drug conjugates, require tailored assays to ensure that all relevant domains are captured and measured accurately.
Therapeutics with multiple functional domains, such as bispecific antibodies, fusion proteins, or antibody-drug conjugates, require tailored assays to ensure that all relevant domains are captured and measured accurately. At FyoniBio, we perform:
We quantify drug concentrations in clinical and preclinical samples to help you understand how your therapeutic behaves in the human body. Accurate PK data is essential for optimizing dosing strategies, ensuring patient safety, and guiding clinical trial progression.
All PK studies are conducted in our GCLP-compliant, ISO 9001-certified laboratories, supporting the development of a wide range of biotherapeutics from early to late clinical phases.
Our experienced scientists develop PK assays tailored to your therapeutic’s biochemical properties, clinical application, and biological matrix. We apply both ligand binding assays (LBAs)—including ELISA and ECLIA on the MSD platform—and mass spectrometry (MS), selecting the most appropriate technology based on molecule type and detection requirements. To address matrix-specific challenges and ensure optimal assay performance, we offer a range of validated formats.
Therapeutics with multiple functional domains, such as bispecific antibodies, fusion proteins, or antibody-drug conjugates, require tailored assays to ensure that all relevant domains are captured and measured accurately.
Our scientists are experienced in developing PK assays for these advanced modalities, including custom bridging and sandwich formats that ensure comprehensive drug quantification across all functional domains.
Compare available PK assay formats and learn how FyoniBio selects and customizes the right platform to support your clinical strategy
Our validation processes ensure precise, reproducible, and regulator-ready data across therapeutic types and biological matrices. We use real patient samples, spiked matrices, and QC panels to confirm every assay is fit for purpose.
Clinical samples often contain interfering components like lipids, heterophilic antibodies, cytokines, or proteases that can compromise assay performance. We apply advanced validation strategies—such as parallelism testing, dilution linearity, and incurred sample reanalysis (ISR) to ensure accuracy and reproducibility under challenging conditions.
Learn more about critical validation parameters, matrix challenges, and stability factors that influence regulatory acceptance, and how FyoniBio ensures assays are fit for purpose across clinical phases.
Biotherapeutics — including small oligonucleotides, peptides, and monoclonal antibodies—can trigger immune responses that lead to the formation of anti-drug antibodies (ADA). These antibodies may neutralize drug activity, alter pharmacokinetics, reduce therapeutic efficacy, and in some cases, cause serious adverse reactions.
At FyoniBio, we develop and validate immunogenicity assays under global guidelines, using a three-tier electrochemiluminescence (ECL) method on the MSD platform. To support your clinical needs, we apply tailored sample pretreatment strategies — including acid dissociation, solid-phase or bead-based extraction, and precipitation — to enhance drug tolerance, minimize matrix effects, and ensure sensitive, specific, and reliable assay performance.
Understand the essentials of ADA testing and how FyoniBio ensures assay reliability, regulatory compliance,
and reduced risk throughout your clinical program.
Pharmacokinetic is sometimes described as what the patient’s body does to the drug. It comprises the processes and time course of liberation, adsorption, distribution, metabolism and excretion of the drug.
PK data can be used to link the drug exposure to the observed efficacy and safety. Knowledge of drug levels helps in choosing the appropriate application route, dosage, and schedule of a drug and may furthermore indicate immunogenicity effects. The assessment of a drug’s PK is therefore a very important tool during pre-clinical and clinical drug development.
For establishment and validation of our bioanalytical methods we apply the current international bioanalytical guidelines of ICH, FDA and EMA (see also guidelines to bioanalytical method validation).
Any biological drug, from small oligonucleotides and peptides to large therapeutic proteins such as antibodies, may elicit an immune response when applied to animals or humans. However, the risk of unwanted immune responses depends on size, structure, and application route, among others. Generally, immunogenicity testing is required for all biological drugs, based on a risk assessment.
Assays used for the immunogenicity assessment of patient samples have to be validated for their intended purpose. Fully validated assays have to be used within pivotal studies required for marketing authorization application.
The assay development time depends on the project and may be affected by availability and quality aspects of the critical reagents, matrix effects and drug tolerance issues. Typically, a new assay is established and prepared for validation within 3 to 4 months. The experimental phase of assay validation takes about 2 to 4 weeks and the subsequent reporting including QC/QA will be accomplished in another 4 weeks. We recommend to get in touch with us early to discuss the requirements of your project and to avoid potential delays.
Our experienced team is here to provide the analytical support and insights you need to move your program forward.
Why choose us
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Illustration designer: Tilo Schneider
