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BioGenes GmbH

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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.

The company works in close collaboration with customers to provide antibodies to the highest quality standards to meet the demands of challenging projects for academic and commercial labs throughout the world.

  • Production of polyclonal antibodies
  • Development and production of monoclonal antibodies
  • Anti-idiotypic antibodies (anti-IDs)
  • Modification of antibodies

 

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 immunoassays are designed based on microtiter plates either as a competitive or sandwich assay. 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:

  • Antigen and antibody characterisation
  • HCP coverage determination
  • DIGE analysis of process samples
  • Stability and performance testing
  • Sample determination of APIs and impurities
  • Sample determination of in-process controls (IPCs)
  • Documentation according to regulatory guidelines

List of methods:

  • Electrophoresis (SDS-PAGE) and Western Blotting (1D and 2D)
  • 2D DIGE Western Blot (fluorescence based)
  • Spectroscopy (UV-VIS)
  • Protein determination  (CBB, BCA, UV)

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

BioGenes GmbH
Koepenicker Str. 325
D-12555 Berlin
Germany
Tel: +49 (0)30 6576 2396
Fax: +49 (0)30 6576 2397
service@biogenes.de
www.biogenes.de

 

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