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.
Products & Services
BioGenes service portfolio encompasses five main activity fields:Custom antibody development (pAbs, mAbs, anti-IDs)
Since foundation, BioGenes has specialized in highly sophisticated custom monoclonal and polyclonal antibody development for industry and research, founded on strong biochemical and immunological expertise. 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.
BioGenes can assist with a wide range of specific testing requirements, from anti-idiotypic antibodies (anti-IDs), development of antibodies for use in biosimilar development and antibodies for ELISAs to use in quality control of production processes.
BioGenes scientists have successfully developed antibodies against various kinds of antigens, including:
- Proteins and protein mixtures
- Phosphorylated and methylated antigens
- Small organic molecules and haptens
Custom ELISA development and qualification, kit production
As a trusted and experienced immunoassay expert, BioGenes can supply clients with specialized ELISA and HCP assay development and optimization, pre-validation, and kit production.
Its immunoassays are designed based on microtiter plates or tubes, either as competitive assay for the determination of haptens, or sandwich assay for the determination of proteins. These are available as single services or full-service packages, and as assay components or complete kits.
ELISA services include:
- Biotinylation of antibodies and search of suitable antibody pairs
- Testing of cross reactivities against various proteins
- Optimization of assay parameters including plate-coating conditions and buffers
- Determination of analytical assay parameters
- Production of complete kits or assay components in agreed quality and quantity
- Stability testing of the kits or assay components
- Permanent quality control of all components
- Pre-Validation according to ICH guidelines
Host cell protein (HCP) assays
BioGenes is an expert in the development of highly sensitive Host Cell Protein (HCP) assays. Its scientists have developed HCP assays for products derived from various cell lines and origins, including Chinese hamster ovary (CHO), E. coli, yeast, NS/0, moss, avian, duck and human.
BioGenes offers two types of HCP assays:
- Generic HCP assay kits: BioGenes has developed a new generation of enhanced generic HCP ELISA assays, based on a 360-HCP approach to produce assays that are demonstrably superior in minimizing well-known limitations including the possibility that anti-HCP antibodies might not comprehensively detect HCPs present in an end-user's sample. While traditional generic HCP assays provide just a single antibody that must work for all processes the 360-HCP ELISA comprises four kits, each using a different anti-HCP antibody to provide better sample matching.
- Custom specific and multiproduct HCP assays: These assays are generated against cell line–specific HCP populations prepared from optimized cultivation and fermentation processes for sponsors who produce a specific product or use a proprietary production cell line for multiple products. All assays are developed according to the highest quality standards required by the FDA and EMA.
HCP assay services include:
- Project design and management in close cooperation with the customer
- In-house antibody development and characterization (2D analysis, ELISA, Western Blot)
- Development of HCP assays in buffer solution and working matrices
- Qualification/pre-validation of HCP assay according to customer’s requirements and ICH guidelines (ICH Q2B)
- Production of complete kits or assay components
- Technology transfer to the customer including SOPs and staff training
BioGenes possesses unrivalled scientific expertise in immunoassay development for biotech, pharma, medical device and clinical diagnostic applications, including biomarker assays that have become an important tool to support drug development.
Besides the development, validation, production of ELISAs and HCP assays, BioGenes supports customers with a wide range of analytical services including:
- Feasibility studies
- Sample determination of APIs and impurities in matrices
- Sample determination of in-process controls (IPCs)
- Stability and performance testing according to customer’s requirements
- Documentation according to regulatory guidelines
- Antigen and antibody characterisation
BioGenes analytical services are supported by a range of cutting-edge technologies that include:
- Electrophoresis (SDS-PAGE) and Western Blotting (1D and 2D)
- 2D DIGE Western Blot (Fluorescence based)
- Spectroscopy (UV-VIS)
- Protein determination (CBB, BCA, UV)
Structure and history
BioGenes celebrated its 25th anniversary in 2017, having been founded in July 1992 by Dr. Alexander Knoll, who is the company’s Managing Director, and Dr. Sergej Ovodov (Scientific Director). Drs. Knoll and Ovodov sole owners of BioGenes after a management buyout in October 2015.
Dagmar Schwertner-Knoll is Marketing & Sales Director.
BioGenes is headquartered in Berlin with a workforce that now numbers 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, including Boehringer Ingelheim, Novartis, Valneva (former Vivalis), and Sanofi Pasteur.
BioGenes has especially close partnerships with Biosyntan GmbH in peptide synthesis and with Trenzyme GmbH in protein expression and Italy’s RTC S.P.A.
Quality and Regulatory
Since 1999, all BioGenes processes have been quality certified to ISO 9001 standards, with its state -of-the-art facilities in Berlin compliant with ISO 9001:2008 guidelines.
BioGenes is also certified to meet all international requirements and regulations for quality assurance and animal welfare.
BioGenes quality and regulatory compliance is backed up by regular audits by authorities and customers, along with well-established quality management systems, SOPs and rigorous employee training.
The BioGenes mission is guided by strong commitment to quality and service reliability, along with proactive project management.
To learn more about BioGenes services and capabilities and how they can assist your business, please contact the supplier.
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