BioGenes Introduces New Tools for Immunogenicity and PK Testing

Berlin, Germany: – Leading force in host cell protein (HCP) assay development, BioGenes GmbH, has rolled out a new suite of tools and services for immunogenicity and pharmacokinetic (PK) testing.

The new tools include custom development of immunogenicity and PK assays as well as corresponding antibodies plus ELISA qualification and pre-validation.

Targeted anti-drug antibodies

Thus, BioGenes can now develop targeted polyclonal anti-drug-antibodies as control for immunogenicity studies and monoclonal antibodies for PK immunoassays based on its optimized technology. The development services include production and pair search of antibodies.

Currently, monoclonal and polyclonal antibodies are available for Adalimumab, Infliximab, Tocilizumab and Golimumab. Further anti-drug-antibodies are in development.

GLP validation and sample measurement

BioGenes is delivering the new services in collaboration with its GLP validation and sample measurement partner, Eurofins Munich.

However, BioGenes will transfer the ELISA testing and protocols to the client’s own laboratory or chosen CRO, if preferred.

BioGenes first exhibited the new service range at the recent Biologics & Biosimilars Congress in Berlin, where they attracted significant visitor interest.

Accessible service

“The procedure of ordering these new services is very simple,” said BioGenes Marketing & Sales Director, Dagmar Schwertner-Knoll.

“The client only has to fill out a brief questionnaire that answers questions like what kind of ELISA or antibody development is required, which therapeutic or biosimilar is to be targeted and whether suitable antibodies or samples can be provided. The rest is done by BioGenes and Eurofins,” she explained.

About BioGenes GmbH

BioGenes GmbH (BioGenes) is an acknowledged global leader in host cell protein (HCP) assay development and a recognized partner of pharmaceutical companies all over the world. The Berlin-based company specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery.

BioGenes is known as a trusted and experienced expert in immunoassay, 2D electrophoresis and antibody development with a business strategy focused on driving forward innovations for customers and building new strategic partnerships aimed at cementing its market leadership in host cell assay development.

BioGenes was founded in 1992 by Dr. Alexander Knoll (Managing Director) and Dr. Sergej Ovodov (Scientific Director), who are now sole owners following a management buyout in October 2015. Headquartered in Berlin, the company has a workforce numbering more than 50 people, most of them scientists.

The company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world.