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 uses their experience in process development and optimisation to deliver a robust, scalable high yielding manufacturing process for your molecules.
For upstream culture, we have 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:
• 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.Know More