Bioanalytical Services Performed under
“Good Clinical Laboratory Practice” (GCLP)
With over 20 years of bioanalytical experiences and multiple clinical studies from phase I to phase IV performed, FyoniBio offers extensive bioanalytical services to support the clinical development of any biopharmaceutical drug – from small oligonucleotides to large proteins.
Our core competencies are the evaluation of pharmacokinetic and pharmacodynamic characteristics of biotherapeutics as well as their immunogenicity when applied in patients. Therefore, drug-tailored sophisticated assays and techniques are developed to meet customer-specific requirements.
The portfolio is complimented by analysis of single nucleotide polymorphisms (SNP), such as the Fcγ receptor SNPs, supporting patient selection and stratification. Additionally, we can support your clinical trial by monitoring the presence and fraction of various immune cell populations in patients and by checking for specific immune functions.
Working with us you can rely on sound knowledge of bioassay development and validation as well as routine sample analysis according to the current ICH, FDA and EMA guidelines and compliance with ISO 9001 and “Good Clinical Laboratory Practice” (GCLP).
Do you need more information? Get in touch with our analytical experts to discuss how FyoniBio can support your clinical drug development program .
Our Core Competencies
- Project consultancy
- Assay establishment
- Assay validation according to current guidelines
- Bioanalysis of clinical samples
- Immunomonitoring of clinical trials
- Sample storage under
24/7 controlled conditions
- ELISA in all formats
- Electrochemiluminescence (MSD)
- Mass spectrometry (LC-MS/MS) based PK analysis
- Flow cytometry
- Cytotoxicity & cellular immunoassays
- DNA melting curve analytics (LightCycler®)
Learn more about our Immunogenicity, PK and PD Testing Capabilities
- Analysis for anti-drug-antibodies (ADAs) using screening/ confirmatory/ titration assays
- Analysis of ADA for neutralizing activity
- Pharmocokinetic analysis (PK)
- Biomarker serum levels (PD)
- Cytokine release
- Cellular immune status (CD marker)
- Immune cell function (e.g., CDC activity)
- Genetic mutations (SNP)
Clinical Bioanalysis Flyer
FyoniBio and Biogenes PK & Immunogenicity Flyer
ISO 9001:2015 Certificate