Services

We at EUGENEX Biotechnologies provide a one-stop-shop from the gene of interest to the process and transfer to GMP production of your protein. All of our services are available on a modular basis and can be tailored to meet your exact demands. Whether cell line and process development or cell-based assays and protein analytics

– We will make your product a success story.

EUGENEX One-Stop-Shop

Cell Line Development

Cell Line Development

Our cell line services rely on our powerful and well-established GeneXpress platform which is based on high-level pMOZ expression vectors, mammalian host cell lines, and our chemically defined cell culture media. Our expression platform guarantees high product yield in gram scale, the best quality and is approved by regulation authorities like the FDA and EMA.

• Amino acid sequencing of the desired protein by LC/MS
• Optimization of gene sequence and expression cassette
• Cloning of DNA sequences in our high-level pMOZ expression vectors
• Stable transfection of our reliable CHOSI host cell line
• Selection of stable minipools
• Screening of minipools in fed batch mode regarding product titer and product quality
• Single cell cloning with photo documentation to ensure clonality
• Testing of long-term stability
• Generation of a master seed cell bank (MSCB)
• Comprehensive documentation
• Process accompanying analytics and assays for protein characterization

Upstream Process Development 

Upstream Process Development 

Every step in our USP development is designed to optimize quality and quantity of the manufactured protein and ensures a successful transfer and scale up for productions at all scales. Through our many years of experience in USP and our state-of-the-art equipment we can guarantee high-quality, cost-effective biomanufacturing processes for our customers. Our USP services can be completely customized and include bioprocess development, redesign, and optimization of an existing process as well as training.

• Development and optimization of robust and scalable production process regarding high product titer and product quality (expected titer in fed-batch: 2-8 g/L)
• Upstream process development in batch, fed-batch, and perfusion mode (1L-350L scale)
• Development and optimization of media and feeding strategies
• Scale-up and contract manufacturing under non-GMP of up to 350L bioreactor volume
• Process accompanying analytics and assays for protein characterization
• Technology transfer including demonstration and training

Downstream Process Development

Downstream Process Development

Recovery and purification of biopharmaceuticals are important steps that have a great impact on product quality and manufacturing costs. We at EUGENEX Biotechnologies offer downstream process development and optimization customized for the unique characteristics of the desired protein. This includes removal of residual DNA, host cell proteins, and removal of potential viruses. With our broad expertise in the systematic purification of monoclonal antibodies, fusion proteins, and other biopharmaceuticals, we are able to remove impurities and increase yields with minimal steps to facilitate a cost-efficient manufacturing.

• Clarification of harvest by different techniques
• Product isolation and purification using various chromatography techniques
• Product polishing
• Downscaling for virus studies and analytic purposes
• Scale-up and contract manufacturing of biologicals under non-GMP conditions up to kg scale
• Process accompanying analytics and assays for protein characterization
• Technology transfer including demonstration and training

In-Process-Control & Analytic

In-Process-Control & Analytic

Our in-house analytical team continuously monitors and optimizes the performance of our processes using a broad spectrum of analytical techniques. As we are well acquainted with global registration requirements and guidelines, our analytical characterization and documentation fulfills the increasing demands of authorities.

• Spent medium analysis: amino acid analysis (RP-HPLC), glucose, lactate, glutamine, glutamate, ammonia, LDH, ect.
• Protein analysis: total mass (LC-MS), sequencing (LC-MS), peptide map (RP-HPLC), deamidation (LC-MS), oxidation (LC-MS, RP-HPLC), folding (HIC-HPLC, fluoro-scan), dimerization/multimerization (SDS-PAGE, SEC-HPLC), charge variants (IEX-HPLC), identity (SDS-Western, ELISA, HPLC), purity (SDS-PAGE, HPLC).
• Glycan analysis: isoform pattern (IEF, CZE), glycan pattern (HILIC-HPLC, CE-LIF), sialylation (HPLC)
• Functional analysis: binding studies, cell-based bioassays
• Genetic analysis: copy number determination (Real Time PCR), truncated mRNA (RT-PCR, sequencing)
• Method development, method qualification/validation, transfer and training

Are you interested in products in advanced stages of development?

Check out our ready-to-go biosimilar processes!