BioGenes GmbH

Exhibitor

Company Profile 

BioGenes: Superior Services Since 1992  

BioGenes GmbH is an expert and a top-level service provider of customized immunoassays, analytical services and antibody development, with a strong commitment to quality and service. The company was founded by its two managing directors, Alexander Knoll and Sergej Ovodov, in Berlin in 1992. Since then, BioGenes has been constantly growing its service and product range, as well as its strong team of specialists. 

For more than 30 years we have been working with large and medium sized pharma and life-science companies as well as CMOs/CROs around the world. Our globally highly recognized services and products are used in the development, testing and production of biological therapeutics. Due to our scientific excellence, highest quality standards and transparent processes, we make sure to never lose track of our main mission: The best possible results for our customers. 

BioGenes in Numbers  

• 30 years of expertise 

• 10,000+ antibody and 400+ assay projects performed 

• 5,000+ customers worldwide, including most of the Top 10 pharma companies 

• 65 dedicated specialists in their respective fields 

• 80%+ returning customers 

Today, BioGenes is recognized across the world as a reliable partner of the pharma and biotech industry. Service is our special focus – from the first detailed offer to the in-depth consultancy with a project manager to the final customer satisfaction survey. Each project handled by BioGenes is treated with special care. 

Other aspects that are valued by BioGenes' service partners are full flexibility and consistent quality. Whether they choose single services or want BioGenes to take over a whole project, we will always make sure to deliver the best possible results, as guaranteed by our rigorous quality policy and ISO-9001 certification. 

Highlights of the BioGenes Service and Product Range  

• Development of custom monoclonal, polyclonal and anti-idiotypic antibodies 

• Host Cell Protein ELISA development 

• Generic Host Cell Protein ELISA kits 

• HCP analytics from 2D DIGE to Western Blot 

• Pharmacokinetic & immunogenicity assays and testing 

Our Products & Services in Detail 

 

Custom Antibody Development  

 

BioGenes offers highly sophisticated custom monoclonal, polyclonal and anti-idiotypic antibody development & production 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. BioGenes specializes in multi-product (platform) and process specific host cell protein (HCP) assays. All assays are developed according to the highest quality standards, as required by the FDA and EMA.  

 

For pharmacokinetic (PK) / immunogenicity studies 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. For this purpose, BioGenes works closely together with their preferred partner FyoniBio.  

 

 

Analytical Services  

 

BioGenes supports customers with a comprehensive range of analytical services which meet all requirements for custom antibody and assay development including:  

• 2D Electrophoresis (lysine-dependent fluorescent minimal labeling, fluorescent total protein staining) 

• 2D Western Blot for determination of HCP coverage (fluorescence based) 

• 2D Difference Gel Electrophoresis (2D-DIGE) for comparative analysis of spot patterns 

• Immunoaffinity Chromatography (IAC) with 2D DIGE and mass spectrometry as orthogonal method for HCP coverage determination 

 

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 four types of generic HCP ELISA kits for CHO and E.coli cell lines respectively, including related reagents.  

Quality and Regulatory  

BioGenes has been certified according to ISO 9001 standards since 1999. The company meets the international requirements and regulations of quality assurance and animal welfare. The work performed in our labs, especially for industry customers, and the documentation follows GMP and GLP guidelines.