Process developmentBioprocess development and optimization: building your manufacturing program with expert companies
GMP-certified companies Naobios and Clean Cells, subsidiaries to Clean Biologics, both have taken part into numerous development projects for innovative virus-based biopharmaceuticals:
Process engineering, particularly when considering biologics, requires detailed knowledge and specific equipment to manage the following steps:
- UpStream Processing (USP): cells, also known as cell substrates, form the basis of bioprocesses and are a key-parameter to control. They may be of eukaryotic or prokaryotic nature and adherence- or suspension-based.
Clean Cells and Naobios are using state-of-the art technologies to perfect processes based on static methods, roller bottles, micro-carries and bioreactors.
- Downstream Processing (DSP): biologics need a purification step and, in case of vaccines, an inactivation stage. Naobios and Clean Cells offer downstream process development and optimization during the critical steps of clarification, concentration and impurity removal to maximize yields.
Single-use systems, in particular in bioreactors and filtration steps, are used as often as possible to mitigate cross-contamination risks.
Our companies manage scaling-up programs, an essential step to ensure process continuity from small R&D scale to larger laboratory scale needed for clinical production.
This stage allows manufacturers to maintain or optimize key parameters of bioprocesses and may be performed up to 200L within our facilities.
Transfer to GMP and analytical support
Through extensive knowledge of Good Manufacturing Practices and certifications, the teams at Clean Cells and Naobios perform qualitative bioprocess development activities, closest to clinical requirements, for an easy transfer to pharmaceutical production.
They are helped by expert R&D and GMP quality control teams which develop and validate associated analytical methods needed to track procedures and products attributes and to optimize efficiency.