Galenica AB

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FyoniBio GmbH

Robert-Rössle-Str. 10 13125 Berlin Germany Dr Doreen Weigelt +49-30-9489-2500 contact@fyonibio.com www.fyonibio.com 20+ 2019 ISO 9001 certified and GCLP compliant S1 and Bio2

Service business with own technology platform in cell line development, USP/ DSP development, MS-based PTM & glycoanalytics, bioassays and clinical bioanalysis under GCLP

As spin-out from Glycotope we are a contract development organisation offering our 20 years of experience in developing biopharmaceuticals from cell line development to clinical bioanalysis and bioassays for our customers.

We are an ISO 9001 certified company located on the biotech campus Berlin Buch and operate in part under GCLP.

We provide: › One-stop shop from clone development to RCB for

CHO and GlycoExpress® cell lines › Process development ready to transfer to the GMP facility of your choice › Cutting edge know-how in glycobiology (analytics and cell biology) › Bioassay development for a wide range of proteins › Excellent know-how in PK, biomarker, and immunogenicity analysis of clinical samples under good clinical and laboratory practice (GCLP) › Excellent track record: Delivering high quality in service and products › Professional project management and customer care › Experienced team

Glycosylation and cell line development

Gycosylation is dependent on the host cell line. FyoniBio provides cell line development services using its human GlycoExpress® (GEX®) cell lines as well as its CHO platform technology CHOnamite® .

Process development

We offer upstream, downstream, formulation, and analytical development.

Our upstream process development is based on mammalian cell culture systems (GlycoExpress®, CHO-K1, CHO-DG44, and others) for fed-batch, perfusion, and intensified fed-batch processes.

Analysis of PTMs (incl. N- and O-glycosylation)

We are skilled in state-of-the-art and advanced highresolution analytical UPLC-MS methods for various biomolecules.

Clinical bioanalysis

Our core competencies are the evaluation of PK and PD characteristics of biotherapeutics as well as their immunogenic and neutralising potential. Assays are established and validated according to the current ICH, FDA, and EMA guidelines. Samples are analysed under “Good Clinical Laboratory Practice” (GCLP).

Analysis of SNPs is another service of ours to select and stratify patients in clinical trials.

Bioactivity and cellular assays

Adequate bioassays are needed during all stages of drug development.

We establish cell-based assays using different target and effector cells including human primary immune cells. Assay validation and application within clinical trials is our daily business.