SERVICES BASED ON
“Good Clinical Laboratory Practice” (GCLP)
FyoniBio has many years of experience in assay development and validation to analyze blood samples from patients in the course of clinical trials. Sample handling, storage and analysis are performed under “Good Clinical Laboratory Practice” (GCLP).
We offer ISO 9001 compliant services to ensure controlled quality of immunomonitoring and bioanalytical services. Assay validation and bioanalysis is performed according to the current ICH, FDA and EMA guidelines.
Our core competencies are the evaluation of pharmacokinetic and pharmacodynamic characteristics of biotherapeutics as well as their immunogenic and neutralizing potential. 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.
We are able to analyze your non-clinical and clinical samples to support your drug development.
Immunogenicity testing, PK and PD assessment under GCLP
- Analysis for anti-drug-antibodies (ADAs) using screening/confirmatory/titration assays
- Analysis of ADA for neutralizing activity
- PK analysis
- Biomarker serum levels
- Cytokine release
- Cellular immune status (CD marker)
- Immune cell function (e.g. CDC activity)
- Genetic mutations (SNP)
- ELISA in all formats
- Electrochemiluminescence (MSD)
- Mass spectrometry (LC-MS/MS) based PK analysis
- Flow cytometry
- Cytotoxicity & cellular immunoassays with >100 cell lines and primary cell preparations
- FcγR binding assays (αlphaScreen®)
- DNA melting curve analytics (LightCycler®)
- Tissue processing and embedding
- Tissue sectioning
- Immunohistochemical staining
Our core competencies
- Project consultancy
- Assay establishment
- Assay validation according to current guidelines
- Immunomonitoring of clinical trials
- Sample storage