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Process Development - Rodon Biologics

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
Development of a reproducible and productive culturing process is one of the key stages for the effective manufacture of a recombinant protein. 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. During development, the analytical and the process development teams are highly integrated to guarantee quick results and that we hit the right product characteristics.

Analytical method development
Rodon Biologics’ develops analytical methods for in process control, product testing and product characterization.

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.

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

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.

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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