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Biofidus AG

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Year Established:
Bielefeld, NRW, DE
Company Type:
Small Business (1-10M TTM Revenue)
Completed Requests:
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Biofidus is specialized in the structural and functional characterization of proteins, viral vectors and small molecules. With more than 800 completed projects and supporting several big pharma clients as well as more than 70 pharmaceutical SMEs, Biofidus has gained vast experience with a wide analytical portfolio and comprehensive study designs.

Key technologies:
Mass spectrometry | chromatography | capillary electrophoresis | surface plasmon resonance | cell-based assays | next generation sequencing

Key modalities:
mAbs | bispecifics/multispecifics | ADCs | fusion proteins | nanobodies |enzymes | AAVs | VLPs

Services in complex protein studies:
- Initial protein characterization
- Clone selection / lead selection
- Developability assessment
- Impurity characterization
- Forced degradation studies
- Stability testing
- Comparability studies
- Biosimilarity studies
- Process characterization
- Setup, transfer and qualification of analytical methods

Analytical focus for proteins:
- Primary structure
- Amino acid modifications (oxidation, deamidation, isoaspartate etc.)
- Glycosylation
- Charge heterogeneity
- Size heterogeneity
- Purity
- Higher order structure
- Bioactivity studies / functional analysis

Analytical focus for viral vectors like AAVs:
- Complete genome sequencing incl. genome integrity
- (AAV) Particle characterization incl. full/empty ratio and capsid PTMs
- Vector quantification
- Process related impurities
- Product related impurities

Analytical focus for small molecules:
- Spent media analysis (nutrients, waste metabolites, etc.)
- Surfactants / excipients
- Small molecule based APIs
- Antibiotics

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Biofidus AG
Morgenbreede 1 Bielefeld, NRW, 33615 Germany

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