At FyoniBio we offer ISO 9001:2015 certified services in different stages of biopharma development. Customer satisfaction is of highest importance and you can expect highest efficiency and competitive timelines in all service offerings. We commit to transparency at every stage through our dedicated project management.

We offer a unique portfolio of cell line and process development services allowing to compare client’s glycoprotein project in our CHOnamite® platform consisting of CHO-K1 as well as CHO-DG44 cell lines as well as our proprietary GlycoExpress® (GEX®) technology with regard to productivity and quality. Fast track and low-cost feasibility studies are used to identify the starter cell line.

The Upstream Process (USP) Development is based on mammalian cell culture systems and aims to identify the optimal production mode being it fed-batch, intensified fed-batch or perfusion.

Downstream processes (DSP) development goes hand in hand with the USP development and includes all up-to-date methodologies to obtain a robust and regulatory sound process. All analytical tools incl. if needed complex bioassay development (e.g. ADCC, CDC, receptor activation, proliferation, apoptosis assays) are setup for transfer to the GMP facility.

For support in cell line and process development as well as for in depth characterization of the customers protein project for providing IND/IMPD characterization chapters we provide Mass Spectrometry (MS) based glycan and protein analytic.

Finally, the Clinical Bioanalysis group provides all assays to analyze blood/serum samples from patients in the course of clinical trials (e.g. PK-, ADA-, NAb-Assay development).

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News

• CSL Behring and FyoniBio Partnering

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Upcoming Events

• World Smart Bioprocessing Summit Pharma 4.0
• CHI Immunogenicity Bioassay Summit
• Festival of Biologics

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