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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
phone +49 (0)30 6576 2396
email service@biogenes.de
web www.biogenes.de
email Koepenicker Str. 325 D-12555 Berlin Germany
 
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Industry Events

BioTrinity 2020

28-29 April 2020, Etc Venues, London

BioTrinity is a long-running and highly regarded two day life sciences conference that takes place in Central London from 28-29 April. BioTrinity focuses on partnering, investment and collaboration and aims to inspire growth and create opportunities for all who attend. The core delegate mix includes early-stage and emerging biotech, medtech and digital health companies, big pharma executives and life sciences investors.
More info >>

 
News and Press Releases

Northway Biotechpharma enters into Development and Manufacturing Agreement with Synklino

Vilnius, Lithuania, and Copenhagen, Denmark – December 18th 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Synklino, a company active in developing a therapeutic protein based therapy as treatment for cytomegalovirus (CMV) infection, announced today that they entered into a Development and Manufacturing Agreement for the recombinant fusion protein SYNx, which Synklino aims to bring into clinical trials.
More info >>

 
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