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Our Services

Yposkesi is a full-service CDMO, providing professional support through all stages of gene therapy development. We make available the entire viral vector manufacturing services necessary to enable you to rapidly and successfully develop ATMPs. You gain access to specialized expertise with integrated project management as well as streamlined and cost-efficient bioprocess development services:

Bioprocess development (USP & DSP)

Yposkesi is fully equipped to handle process development projects from the outset, from small scale process evaluation, process scale-up and the performance of full scale feasibility batches in pilot lab. We can support the initial stages of your project such as productivity evaluation, comparison of different vector constructions and your choice of an industrial process (adherent vs. suspension processes).

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Small-scale process development

You will have access to a Process Development team dedicated to small-scale evaluation and process optimization. This group performs process evaluation and optimization studies at a scale of 2 to 10L bioreactor (for suspension process) or in cell factories (for adherent process). We master several types of purification technologies, amongst which chromatography (multiple sorbents used) as well as tangential flow filtration.

We are using DOE in our development studies to identify and optimize efficiently several key quality attributes of your product, such the concentration ratio of plasmid DNA/Transfection reagent/cell density, the ratio full/empty particles, and the comparison of several vector constructions on the different platforms available.

Industrialization Development

Our Industrial Development group will meet your requirements for process scale-up and transfer of the final process to GMP manufacturing. Process scale-up experiments can be performed up to 200 litres in a Single Use Bioreactor or up to 24 Cell Factory 40 for adherent cells.

This team is also in charge of the preparation of all the documentation required for the production of the clinical lots: Bill Of Material, the registration of new raw material, etc.

 

Analytical Support

Our Analytical Group performs assays (in-process or product characterization) to support your bioprocess development.  

Our platform