At FyoniBio, we deliver precise bioanalytical characterization to ensure your therapeutic’s quality, consistency, and regulatory readiness. From small oligonucleotides to large proteins, our services adapt to the structure, modality, and development stage of your biologic.
Our scientific team draws on deep expertise in immunology, cell biology, molecular biology, and protein chemistry—applying proven analytical methods to fit the specific needs of your molecule and program.
Whether you’re generating feasibility data, conducting comparability studies, or preparing for regulatory submission, we work as an extension of your team, delivering scientifically robust, well-documented results without unnecessary complexity or delays.
Why choose us
01
Benefit
We work across a broad spectrum wide range of biotherapeutics, including monoclonal antibodies, bispecifics, antibody-drug conjugates (ADCs), fusion proteins, biosimilars, oligonucleotide-based therapeutics, glycoproteins, blood factors, hormones, and radiopharmaceuticals.
02
BENEFIT
Whether you need biochemical analytics, mass spectrometry, or functional and potency assessments, our team provides the insights you need to confidently advance your project. Our services are fully integrated to deliver a comprehensive view of your product’s profile.
03
BENEFIT
We tailor every analytical workflow to your study objectives, molecule type, and regulatory requirements—delivering relevant, actionable data to support confident decision-making.
04
BENEFIT
All services are conducted under ISO 9001-certified quality systems and in full alignment with ICH, FDA, and EMA guidelines—ensuring consistency, compliance, and clear documentation for your submissions.
We apply a broad range of biochemical techniques to monitor product quality and performance across upstream and downstream workflows. These methods support detailed characterization of identity, purity, aggregation, and biological activity. The assays can be validated on customer request.
Our mass spectrometry services provide in-depth biochemical characterization of biotherapeutics, ensuring accuracy in defining critical quality attributes such as integrity, glycosylation, and post-translational modifications (PTMs).
For advanced UPLC-QTOF-MS/MS methods we employ high-resolution UPLC systems (Waters) coupled to accurate QTOF mass spectrometers (Bruker). Our specialized glycan profiling technologies comprise fluorescence tags like RapiFluor® and 2AB labeling in addition to mass spectrometry to deliver precise, reliable data for your product development and quality control needs.
Our functional and potency bioassays assess biological activity in alignment with your therapeutic’s mechanism of action. We apply physiologically relevant systems both non-cellular, reporter cell- and other complex cell-based assays —to evaluate binding, signaling, cell viability, cytotoxicity, blood clotting, and immune function across a wide range of formats.
With a dedicated mammalian cell culture facility and access to over 130 different human and animal cell lines, we ensure physiologically relevant assays that mimic in vivo conditions for biologic characterization.
If you're unsure about the best approach for characterizing your biologic, our team is here to help. Contact us today to discuss your project, and we’ll guide you to the most suitable bioanalytical solutions for your needs.
Our expertise
“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.”
“Two decades of experience in glycoprotein analytics and our reliable UPLC/QTOF-MS systems enable us to deliver conclusive, meaningful insights—especially where others fall short. Just as important: we communicate openly and clearly, so you always know what the data means and what to do next.”
“Our tightly interwoven expertise in protein purification, formulation, and biochemical analysis forms the backbone of our team. With experience across all protein types, we develop processes and methods that meet even the most specific requirements—always with an eye on future GMP compliance.”
Our experienced team is here to provide the analytical support and insights you need to move your program forward efficiently, confidently, and without delays.
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Illustration designer: Tilo Schneider