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Summary

Short Business Description

FyoniBio is a CDO/clinical laboratory offering customized services at different drug development stages to pharma and biotech companies.

General information

Company profile

FyoniBio’s CDMO service portfolio is based on 15 years of experience in biopharmaceutical CMC projects and delivers innovative scientific solutions for biopharmaceutical development. We offer fully integrated ISO-9001:2015 services, from the development of stable high-titre cell lines in mammalian expression systems and robust process development to drug product quality control and comprehensive bioanalytical capabilities for preclinical and clinical studies.

A special focus lies on our versatile and robust cell line portfolio, which includes our highly productive CHO platform technology CHOnamite® (for high-yield production of up to 10 g/L), our proprietary CHOFlow® cell line (a FUT-8 KO cell for ADCC enhanced afucosylated mAbs) as well as the human GlycoExpress® platform (for complex glycoproteins).

Products & Services

– Versatile and robust cell line portfolio, which includes our highly productive CHO platform technology CHOnamite® (for high-yield production of up to 10 g/L), our proprietary CHOFlow® cell line (a FUT-8 KO cell for ADCC enhanced afucosylated mAbs), as well as the human GlycoExpress®
– Customized feasibility studies to select the best suitable host cell line meeting the requirements for each individual complex recombinant protein.
– State-of-the-art cell line development using the CellCelector technology to select highest expressing clones meeting the monoclonality requirements
– Integrated robust upstream (USP) and downstream (DSP) development, as well as analytical development, to competitive accelerate timelines.
– Extensive protein characterization (e.g., PTMs; N-glycans; O-glycans) ensured by our in-depth expertise in mass spectrometry.
– Bioassay development (e.g., ADCC, CDC; ELISA, FACS).
– Clinical bioanalysis (PK, ADA) for proteins and oligonucleotides under GCLP regulations.

Target group

FyoniBio serves pharmaceutical, biotech companies, and research institutions in Europe and North America, offering tailored solutions for drug development needs. From startups to established firms, our expertise supports diverse clients in advancing research and development.

Company information

Company name

FyoniBio GmbH

Street

Robert-Roessle-Str. 10

Zip code

13125

City

Berlin

Country

Germany

Internet / Website

http://www.fyonibio.com

Contact person

Title

Dr.

Name

Ulrike Scheffler

Position

Senior Director Business Development

Language

English, Deutsch

PROJECTS

Project List

GAB Japan 2024 Gesundheitswirtschaft

Projects WebSite

GAB Japan 2024 Gesundheitswirtschaft