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Cell Line & Process Development - Rodon Biologics

Cell Line & Process Development

Cell Line Development

Rodon has extensive experience with both microbial (E. coli, yeast) and mammalian cell culture derived proteins. Using our proprietary and in-licensed technology for expression proteins are rapidly screened in different constructs, to identify the most suitable system, using tightly-regulated inducible promoters for microbial cells. In mammalian cells Rodon provide rapid cell line generation using CHO platforms.

Cell line development based on a simple workflow which allows obtaining a high-producing single cell clone in 16-20 weeks. Moreover, once a high producing pool is generated, the quality of the material is evaluated and it can be used to produce gram-per-liter quantities of material in 9-12 weeks. The selection strategy has been designed to identify cell lines that are highly productive and have the ability to grow well in suspension culture in a fed-batch fermentation process.

The stability of the stable clone is evaluated to guarantee that after several passages their ability to express the protein is maintained. We have found that using this technology, even after 60 generations, the expression level of the stable clone is comparable to the earlier generations.

Process Development

To effect critical time to market, companies will need to consider their cell line & process development strategies early in the drug development cycle, taking the investment risk of increasing their own capacity and resource base or alternatively limiting that risk by outsourcing.

Rodon Biologics has an experienced and qualified team of individuals, resources and proven record in the area of Biologics process development integrated across several areas.
Rodon’s development activities are performed as a stand-alone service or are fully integrated into a cell line & process development program.

Upstream process development
Rodon use their optimisation experience to select appropriate conditions for production activities, using chemically-defined media medium carefully created to support high cell densities and expression levels.
The process optimization is performed in parallel with the DSP process development in order to obtain a global high yielding and high quality process. Process development program is also cost effective, robust and transferable driven.

Downstream process development
Rodon Biologics has the in-depth expertise, wide ranging knowledge, and skilled teams to develop new purification methods for various biomolecules. Our track record of success developing downstream processes for a variety of biotherapeutics includes: antibodies, antibody fragments, multi-specifics (Bites, Tribody, Bibodies, Bispecific IgGs), monovalent IgGs, fusions, cytokines, growth factors, hard-to-produce proteins. For microbial processes we have the ability to purify directly from harvest or refold inclusion bodies.
The downstream processes are optimized for optimal recovery and removal of impurities with minimal steps. Our experience allows us to design a development approach that will result in an efficient and scalable purification process.

Analytical method development
Rodon Biologics develops analytical methods for in process control, product testing and product characterisation.
We synchronize our analytical product characterisation with process development to monitor the product quality through the development process. This allows to optimize clone selection, bioreactor conditions and impurities removal during full process development. Nonetheless, our analytical development services are part of a comprehensive development program, they can also be offered as stand-alone services. Rodon expertise includes HPLC, Electrophoresis, ELISA, UV-Vis, binding assays, cell based assays, and others.

At Rodon constant communication and information exchange with the client is promoted as the project progresses to attaining objectives in an efficient and timely manner. Records are meticulously maintained in the appropriate manner ensuring effective management, communication, evaluation of progress and process transfer.

Our services include:
• Plasmid construction with the gene of interest
• Cell transfection with antibiotic selection
• Pool selection and amplification (cell banking)
• Establish clonal CHO cell lines with documented evidence of clonality
• Establish research cell banks (RCB) and study their stability (up to 6 generations without selection)
• Execute and develop thorough analytics and specific assay development support
• Upstream process optimization: test media/feed conditions; optimization of process parameters (2-10L volume bioreactor systems)
• Downstream process optimization: adaption of state-of-the-art purification processes for mABs; process development for non-antibody products
• Analytical methods for in process control, product testing and characterisation
• Analytical method development, method validation and stability studies
Formulation development
• Scale-up and transfer of cell lines, processes and analytical methods into GMP manufacture

We Offer More

Looking for additional services? We offer even more services than listed, contact us to find out how we can assist you. Using latest advances in Protein Technologies Rodon Biologics strives to provide the highest quality custom protein services in the industry. We work closely with you, analyze your project at the planning stage and take several approaches to ensure you get the results you are looking for.

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