BioGenes 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, headquartered in Berlin, Germany, is a recognized partner of biotech and pharmaceutical companies all over the world.
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.
- ELISA development and qualification, 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. 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. Pre-Validation is carried out according to ICH guidelines. All assays are developed according to the highest quality standards required by the FDA and EMA.
- Analytical services
BioGenes supports customers with a comprehensive range of analytical services which meet all of your requirements for custom antibody and assay development including: • HCP coverage determination (2D Western Blots) • DIGE analysis of process samples
- 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 and maintains long-term alliances with biotech and pharmaceutical companies as well as research institutes all over the world. 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.