Since 1992, BioGenes GmbH is an expert and a top-level service provider for custom antibody and immunoassay development and production as well as for complex analytical services. BioGenes offers highly sophisticated custom monoclonal, polyclonal, and anti-idiotypic antibody development & production for use in quality control, biosimilars, PK studies and immunogenicity assays. BioGenes has a proven track record in the development, optimization, pre-validation, and production of highly sensitive and robust Host Cell Protein ELISAs including related analytical services.For pharmacokinetic (PK) / immunogenicity studies together with our partner FyoniBio we offer a complete package ranging from custom antibody and assay development to ELISA validation and the analysis of pre-clinical and clinical samples according to GCLP guidelines.

Our scientists have developed a panel of enhanced generic 360-HCP ELISA (CHO and E.coli) based on a unique approach that increases the specificity and sensitivity of traditional generic HCP assays.