At FyoniBio, we understand that the success of your clinical trial depends on the accuracy and reliability of bioanalytical data. That’s why we offer end-to-end bioanalysis of clinical samples—including blood-derived matrices like serum and plasma, as well as tissue-based materials—in our GCLP-compliant, ISO 9001–certified labs, adhering to ICH, FDA, and EMA guidelines.
We provide reliable bioanalytical support for clinical trials from Phase I to IV, tailoring every assay to your therapeutic and clinical goals. From oligonucleotides to large proteins, our expertise spans PK, PD, and immunogenicity. Each method is developed for relevance, reproducibility, and regulatory readiness. That’s how we ensure consistent, high-quality data—across sites, phases, and programs.
Why choose us
Our core competencies lie in evaluating the pharmacokinetic and pharmacodynamic characteristics of biotherapeutics, as well as their immunogenicity in patients. To meet customer-specific requirements, we develop drug-tailored assays and techniques. Additionally, together with our partner company BioGenes, we complement this service with the development of customized mono- or polyclonal antibodies that you need for bioanalysis.
Support in:
Establishing most appropriate assay for intended purpose
Validation performed according to current guidelines (ICH, FDA, EMA)
Central lab function supporting the sponsor
At FyoniBio, we work as an extension of your team, helping you navigate complex analytical challenges with confidence. You can rely on our deep expertise in bioassay development, validation, and routine sample analysis, all conducted in full compliance with ICH, FDA, and EMA guidelines, as well as ISO 9001 and Good Clinical Laboratory Practice (GCLP).
Want to know more about this service?
Solutions
At FyoniBio, you can expect a proactive and engaged partnership, built on transparency, and collaboration to support your success in clinical bioanalysis.
Our approach is tailored to your study’s unique needs, providing full project visibility through regular updates and dedicated project management, so you stay informed at every stage. We believe in direct collaboration, keeping our team readily available for discussions to ensure alignment with your evolving project requirements.
Whether you’re in the early planning phase or ready to start, our team is here to support you.
Get in touch today! We typically respond within 24 hours.
How we assess drug levels in patient samples for a wide range of biotherapeutics.
How we assess the immunogenic potential of a biotherapeutic drug in patients.
Our expertise
“A unique strength of FyoniBio is to combine all the CMC activities with clinical bioanalysis. Our partners choose us for cell line and process development, as well as assay development and validation to support clinical trials. A distinctive feature of our clinical bioanalysis offering is the ability to analyse therapeutic oligonucleotides, including pharmacokinetics and immunogenicity assessments — a specialty that demands both scientific depth and methodological flexibility.”
“As experts in customized analytical assays for clinical applications, we solve challenges around complex molecules. Our partners value our scientific depth, flexibility, and the direct line they have to us—enabling fast, tailored solutions that fit seamlessly into their development strategy.”
“Oligonucleotide drugs are showing great potential for treating genetic disorders and cancers, with several already approved and many more advancing through clinical trials. At FyoniBio, we use ECLIA technology to support the quantification of these therapeutics and the detection of anti-drug antibodies. This approach allows us to deliver sensitive, reliable results — helping our clients move forward with confidence.”
Take a closer look at our Clinical Bioanalysis offer.
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Illustration designer: Tilo Schneider
