Bioprocess development (USP & DSP)
Your partner from the start
Yposkesi is fully equipped to handle your process development projects from small-scale process evaluations to process scale-ups and the eventual execution of full-scale feasibility batches in pilot labs. We can support the initial stages of your bioprocess project such as productivity evaluation, comparison of different vector constructions and your choice of industrial processes (adherent vs. suspension processes).
Small-scale process development
Working with Yposkesi, you will have access to a process development team dedicated to small-scale evaluations and process optimizations. Our team performs process evaluation and optimization studies at a scale of 2 to 10L bioreactor for suspension processes, and in cell factories for adherent processes. We master several types of purification technologies, amongst which are chromatography (multiple sorbents used) as well as tangential flow filtration.
We use Design of Experiment models in our development studies to identify and optimize several Key Process Parameters of your process (e.g. the concentration ratio of plasmid DNA/Transfection reagent/cell density) to optimize the Critical Quality Attributes of your product such as the ratio of full/empty particles. We provide a comparison of several vector constructions on your different available platforms.
Our Industrial Development group will meet your requirements for process scale-up and transfer of your final process to cGMP manufacturing. Process scale-up experiments can be performed for up to 200 liters in a Single Use Bioreactor or up to 24CF10 Cell Factory for adherent cells.
Our industrialization development team is also in charge of the preparation of all the documentation required to produce clinical lots such as the Bill of Material, the registration of new raw materials, etc.