BioGenes GmbH, founded in 1992 and based in Berlin, Germany, is a worldwide acting full-service provider of customized antibody and immunoassay development with a strong commitment to quality and service.
The company provides highly customized solutions for quality control of biological products, drug discovery, drug development, manufacturing of biologicals as well as for diagnostic purposes. BioGenes is a recognized partner of biotech and pharmaceutical companies all over the world.
Our Products & Services
Custom Antibody Development (pAbs, mAbs, anti-IDs)
BioGenes offers highly sophisticated custom monoclonal, polyclonal and anti-idiotypic antibody development for use in quality control, biosimilar development, PK studies and immunogenicity assays.
Custom ELISA Development, Qualification and Kit Production
BioGenes has a proven track record in the development, optimization, pre-validation and production of highly sensitive and robust ELISAs. The customer can order single services or full-service packages, and either the manufacturing of assay components or complete kits.
BioGenes specializes in multi-product (platform) and specific host cell protein (HCP) assays. All assays are developed according to the highest quality standards, required by the FDA and EMA.
BioGenes supports customers with a comprehensive range of analytical services which meet all of their requirements for custom antibody and assay development including:
- HCP coverage determination (2D Western Blots)
- 2D analysis of HCP samples
- DIGE analysis of process samples
- Immune affinity chromatography (IAC)
Our scientists have developed the enhanced generic 360-HCP ELISA based on a unique approach that increases the specificity and sensitivity of traditional generic HCP assays. We offer each several types of generic HCP ELISA kits for CHO- and E.coli cell lines including related reagents.
For the selection of the most suitable kit for the special process we provide customers with a special “performance study”.
Quality and Regulatory
BioGenes is certified according to ISO 9001 standards since 1999. The company meets the international requirements and regularities of quality assurance and animal welfare. The works performed in our labs, especially for industry customers, and the documentation follow certain GMP and GLP guidelines. Assay pre-validation is performed according to ICH guidelines.