BioGenes GmbH
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. 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 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)
Products
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 four 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 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.
Contact: www.biogenes.de, service@biogenes.de, +49 (30) 65762396
BioGenes Establishes Scientific Advisory Board
Berlin, Germany, December 12, 2017 / B3C newswire / -- BioGenes GmbH, specializing in ELISA development and production and a global leader in host cell protein (HCP) assay development, today announces the establishment of a Scientific Advisory Board which includes the following four renowned experts:
BioGenes Celebrates 25 Years of Excellence in Quality Control of Biotherapeutics
Berlin, Germany, July 25, 2017 / B3C newswire/ -- BioGenes GmbH, specializing in ELISA development and production, is celebrating its 25-year anniversary. In 1992 the scientists Dr. Alexander Knoll and Dr. Sergej Ovodov set out with a vision to provide services and kits for the quality control of biotherapeutics. Over the course of the last...
Koepenicker Str. 325 D-12555 Berlin Germany
+49 (0)30 6576 2396
