Actualités
Clean Mails – June 2024
Increasing biologics manufacturing capacities
Biologics manufacturing encompasses all the processes which allow living material to be transformed into therapies, or biopharmaceuticals. Part of biologics production requires the generation of banks of cells and viruses which are further used to produce large molecules therapeutics. Cell and virus bank manufacturing requires both technical knowledge and strict compliance to cGMP guidelines to provide safe and potent material to biologics manufacturing.
With 23+ years of experience handling hundreds of cell and virus models, Clean Cells has positioned itself as a leader in cell and virus banking, providing complementary characterization and storage services.
Our state-of-the-art cGMP facility launched last year welcomes our biologics manufacturing capacities, providing 8 new clean rooms designed for all types of biopharma projects and equipped to meet production specifications for both adherent and suspension cells. A newly implemented cell cloning platform further integrates our capacities, from initial cloning and selection of the most potent cell lines to fully characterized, ready-to-use cGMP cell & virus banks.
BSL2 and BSL3 laboratories within cGMP environment
Biologics production laboratories are part of a larger setup of cGMP-certified clean rooms, audited multiple times by healthy agencies and clients globally and subject to extensive environmental controls.
Laboratories are qualified for operations involving BSL2 and BSL3 material and genetically modified organisms (GMO).
One-stop-shop CDMO services for bioprocess-ready banks
Clean Cells’ new site of operations includes cell cloning, manufacturing, quality control and storage areas to provide cell and virus banks ready to use for biologics manufacturing.
Our bioprocesses and long-term expertise guarantee potent, safe, and stable banks (MCB, WCB, EOPC) and seed stocks (MVSS, WVSS) with a comprehensive repertoire of characterization and release assays according to worldwilde requirements.
In addition, liquid nitrogen in vapor phase and -80°C short- or long-term storage are proposed in qualified equipments until further use in biologics production.
Extended CDMO services as part of Clean Biologics
Clean Cells is a founding member of life science group Clean Biologics, including CDMOs Biodextris and Noabios, providing development and clinical biomanufacturing services directly complementing Clean Cells’ biologics manufacturing capabilities.