USP (UpStream Processing)
Upstream bioprocess development: de novo development, optimization and scale-up
Naobios offers complete process development services supported by a highly qualified team. Our five independent BSL2 and BSL3 suites allows us to manage activities on different projects in parallel and support all stages of process development for your drug substance: inactivated vaccines, live attenuated viral vaccines, viral vectors or oncolytic virus.
Design of Experiments
The first step to such development is the creation or optimization of efficient upstream bioprocesses.
Our process development activities resort greatly to Design Of Experiment and the development department is able to offer analytical support for all critical process parameters to be considered in the scope of an upstream process development to achieve the desired quantity combined with the required quality and purity.
Custom-made and transferable processes
Naobios benefits from an experienced bioprocess development team able to work in development, optimization and scale up of upstream processes. Our expertise in adherent and suspension cell lines guarantees the best selection and optimization of critical process parameters for cell growth or virus productivity.
We ensure that process development is both bespoke and scalable through the performance of specific assessments including media screening and other process parameters as multiplicity of infection, day of harvest, and other parameters established under a development plan conceived together with your team and readily transferable to the GMP manufacturing group inhouse.
Dedicated and high-quality equipments
The team can use a myriad of cell culture technologies available on site for suspension cell lines and adherent cell lines from small scale (2 to 10L) up to larger 250L scales. The following equipment may be used for various cell lines are:
- Static containers
- Single-use bioreactors (up to 250L).
- Fixed bed bioreactors (iCELLis® Nano and 500 systems)
R&D cell banks and R&D viral seed stocks can also be produced for development activities.
Naobios is able to scale-up your bioprocess up to 250L in stirred tank single use bioreactors, or 500m² in fixed-bed bioreactors.