USP/DSP development and modeling
Optimization of bioprocessThe optimization of a bioprocess is very important for large-scale production as it greatly impacts several parameters, such as target biological productivity, the quality profile of the product, or production costs.
In a typical bioproduction workflow, process optimization is done during cell culture and biological production (upstream processing – USP) and during product purification, formulation, and stabilization (downstream processing – DSP).
Our production platforms include:
- state-of-the-art cryo-storage capabilities associated with robust research cell bank production services
- an upstream platform for adherent and suspension cells, up to 10 l stirred-tank bioreactor for both E. coli and mammalian cells, and fixed-bed bioreactors
- a downstream platform for UF/DF (Akta Crossflow) and purification optimization (Akta Avant), scale-up (up to 100 ml/min), and stabilization (freeze-drying platform)
- an analytical platform for process monitoring (cell culture analyzer, automated cell counters) and characterizing products and impurities (immuno-assays, molecular biology, flow cytometry, mass spectrometry)
- a quality-management system that ensures rigorous data traceability
A solid track record of process development projects
This type of study is also very important for generating robust data, which enables the development of mathematical models using machine learning or other artificial intelligence technologies that can be used for in silico-prediction studies and to further optimize the process.
Our bioprocess platform provides flexible solutions for developing new applications, optimizing specific processes, or generating robust data for mathematical modeling.
CER Groupe has a solid track record of process-development projects and offers services at the development stage of both E. coli or mammalian cell-expression systems for different biological entities. Our analytical platforms are used to support these modeling/optimization campaigns, in order to meet requirements regardless of the project objective and the sponsor: data scientists, bioreactor engineers, biotech firms outsourcing their process development, etc.
Key figures
7 bioreactors available
>2,000 samples per year
3 projects granted for process modeling
CASE STUDY
Characterization of an initial AAV2 DSP protocol throughcombined TFF and two-step chromatography
Viral vectors are complex biological products that require advanced DSP strategies to obtain significant yields of high-quality products for pre-clinical evaluation.