Cell Line & Process Development

Cell Line Development

Rodon has extensive experience with both microbial (E.coli, yeast) and mammalian cell expression and culture. Using our proprietary and in-licensed technology, proteins can be rapidly tested in different constructs, to identify the most suitable system. using tightly regulated inducible promoters for microbial expression and  CHO platforms for mammalian expression as well as metabolic engineering of cell lines to produce small molecules.

Mammalian cell line development is 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 stability of the cell line generated is evaluated and using this technology, even after 60 generations, the expression level of the stable clone and genetic stability  is maintained.

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’s process development services are performed as a stand-alone or integrated with cell line development programs.

Rodon use their experience in process development and optimisation to deliver a robust, scalable high yielding manufacturing process for your molecules.

For upstream culture we use well defined animal component free media carefully created to support consistent and stable high cell densities and expression levels.

The downstream processes use combinations of separations, filtration, membrane and chromatography operations which are optimized for recovery of product and appropriate clearance  of impurities with minimal steps. The DSP is developed in parallel with the upstream culture process.

Our experience with process will deliver an efficient, robust, consistent, well characterised and scalable process.

Regular communication and information exchange with the client is promoted as the project progresses. 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