Bioanalytical Characterization with FyoniBio

Delivering Analytical Clarity Across Every Stage of Biologic Development

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.

20+ Years of Bioanalytical Experience

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

Why Choose FyoniBio for Bioanalytical Characterization?

Biochemical Analytics

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.

HPLC-based methods

Our analytics include Size Exclusion Chromatography (SEC), Weak Cation/Anion Exchange Chromatography (WCX/WAX), Reversed-Phase Chromatography (RPC), and Hydrophobic Interaction Chromatography (HIC)

Protein detection and quantification techniques

Our analytics include ECLIA, ELISA, SDS-PAGE, Western Blot, Isoelectric Focusing (IEF), Dynamic Light Scattering (DLS), and UV/Vis Spectroscopy.

Protein-specific functional and binding assays

We offer advanced functional assays including Octet BLI, DRX2-based affinity and size measurements, and Fc receptor AlphaScreen.

Mass Spectrometry Analytics

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).

Intact protein mass analysis

Glycan profiling and glycopeptide characterization

Peptide mapping and PTM assessments

Antibody-drug conjugate (DAR) analysis

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.

Functionality & Potency Assessment

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.

Target and effector cell binding assays

Including assessment of binding affinity
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Immuno-oncology assays for T-cell activation and cytokine release

Viability, apoptosis, and cytotoxicity assessments

Including complex assays such as ADCC, CDC, phagocytosis, and blood clotting where relevant
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Signaling pathway analysis and receptor activation studies

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.

Let’s Discuss Your Project Needs

Need Help Choosing the Right Characterization Approach?

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

Hear From Our Experts

Beate Habel, PhD
Director of Clinical Bioanalysis

“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.”

Robert Wilmanowski, PhD
Director of Instrumental Bioanalytics

“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.”

Anke Flechner, PhD
Director of Downstream Process Development & Quality Control

“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.”

Speak Directly with Our Scientists

Our experienced team is here to provide the analytical support and insights you need to move your program forward efficiently, confidently, and without delays.

Contact FyoniBio