Hans Baumeister, Managing Director at FyoniBio introduced his company as a leading service provider in developing biotherapeutics and clinical bioanalytics services. He specifically homed in on recent projects for oligonucleotides in complex biological matrices, using hybridization and electrochemiluminescence immunoassays for quantification.
The company serves clients across many different clinical phases from phase I to phase IV across Europe and overseas. A range of assays including PK and immunogenicity assays can be offered to clients. Baumeister stressed the robustness and versatility of FyoniBio’s assays which can be used in various matrices, including liquid and tissue samples.
Baumeister classified an oligonucleotide as an ASO or double-stranded siRNA with between 16 and 21 nucleotides or base pairs with various chemical modifications and conjugates. He introduced an assay used for the quantification of oligonucleotides that combines hybridisation and electrochemiluminescence immunoassay. Two probes are hybridised with the analyte, one probe is biotin-related and used for capture while the other is used for antibody detection. The equipment then provides a readout.
Two case studies were conducted, one with a conjugated ASO and one with a conjugated siRNA ASO. One was conjugated with GalNAc and the other with a lipid. The assay ranges from 1 picomolar to 10 nanomolars with good sensitivity and high degrees of accuracy and precision suitable for clinical application.
Baumeister explained that FyoniBio’s assay approach uses a surrogate matrix to observe differences in matrices. He touched on their approach to anti-drug antibody assays, including screening, confirmation, titration, and neutralising assays. Ongoing research aims to improve the sensitivity and N -1 to N -3 metabolites detection. There were also challenges in detecting anti-drug antibodies against oligonucleotides, particularly with larger conjugates, that researchers are working to overcome.
To sum up, FyoniBio seeks to improve the sensitivity and specificity of assays, particularly for detecting intact molecules and minimising interference from metabolites. Their mission uncovers the criticality of accurate bioanalytics in developing effective biotherapeutics.
