BioGenes offers customized monoclonal and polyclonal antibody development and production, immunoassay development/pre-validation and protein analytical services.
BioGenes is a market leader in custom HCP antibody development and characterization (1D-/2D-gels and Western blots for coverage analysis), DIGE analysis, Host Cell Protein ELISA development, pre-validation and production of ready-to-use ELISA kits.
BioGenes supplier their customers also with specific anti-idiotypic antibodies (pAb or mAb) as tools for pharmacokinetic and immunogenicity studies. Corresponding specific ELISAs can be developed and qualified as custom service too.
NEW! BioGenes offers non-clinical immunization studies in animals including mice, rats or rabbits for several applications (non-GLP).
NEW! Hybridoma sequencing service.

Quality Policy BioGenes GmbH

We are certified according to ISO 9001-2015.
To ensure the long-term fulfillment of specific customer requirements for our products and services, our Quality Management System complies with each requirement and specification of the internationally accepted DIN EN ISO 9001 guidelines since 1999.

We follow a constant process of improvement and are audited annually by an independent certification company to maintain our certification status.

Our laboratory performance meets high quality requirements and is based on the following principles:

• Standardized work which follows SOPs
• Traceable documentation of manufacturing and analytical services according to data integrity principles
• Release testing of products by QC
• Risk-based approach in Quality Management Processes
• Experienced and well-trained personnel
• Using qualified equipment
• Conducting frequent internal and customer audits
• Deploying animals and materials from certified and qualified suppliers

Furthermore, BioGenes ensures that all services where work is carried out with and on animals meet specific animal welfare regulation, including but not limited to the following:

• German Guidelines: Tierschutzgesetz (TierSchG), engl. Animal Welfare Act of 18th May 2006 (BGBl. I S. 1206), last update from 20th December 2022
• German Guidelines: Tierschutz-Versuchstierverordnung (TierSchVersV), engl. Animal Welfare Ordinance on Experimental Animals of 01 August 2013 (BGBl. I S. 3125), last update from 11th August 2021
• European Union Guidelines: EU Directive 2010/63 of 09th November 2010 and the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes of 18th March 1986
BioGenes is deemed to be compliant with the U.S. Public Health Service (PHS) Policy for Animal Welfare.
BioGenes was successfully audited by Merck regarding the animal welfare conditions end of 2023.