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| Lonza's Cell Culture & Process Development team has over 25 years of experience in the development of production processes for animal cell products. A wide range of cell types, (e.g. CHO, hybridomas, various mouse myeloma and human cell lines) have been used to produce monoclonal antibodies (mAbs) and other recombinant proteins using a variety of expression systems. |
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Cell Line Construction
A key factor in reducing the production costs of biopharmaceuticals for our customers is the development of cell lines producing a high yield of product. For recombinant monoclonal antibodies (mAbs) and proteins, Lonza can create vectors to express product using the GS gene expression technology. Antibody yields of up to 10 grams/liter have been achieved using this system in chemically defined, animal, component-free medium. Our customers' products can be expressed in either CHO or NS0 cells. The selection strategy has been designed to identify cell lines that are highly productive and have the ability to grow well in suspension culture in a state-of-the-art, fed-batch fermentation process.
The selection of cell lines compatible with production requirements can lead to significant time savings at later stages. In addition, close interaction with regulatory authorities worldwide ensures that the cell lines will be constructed, cloned and characterized according to current regulatory guidelines.
Learn about our new accelerated clonal cell line construction offering here.
WATCH: Click here to watch a recent presentation titled "Faster and More Efficient Cell Line Development for cGMP Manufacturing," presented by Dr. John Birch, CSO of Biopharmaceuticals, and Dr. Andy Racher, Senior Principal Scientist, Cell Culture Process Development.
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Cell Banking
A dedicated cGMP unit within our licensed UK manufacturing facility is used to create master and working cell banks for subsequent manufacturing use. The cell banks are characterized in accordance with FDA and European regulatory agency requirements. For safety and security considerations, dual-site storage of all cell banks are maintained between our US and UK facilities.
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Molecular Biology - A molecular biology group within the department provides genetic characterization studies on recombinant cell lines according to regulatory guidelines.
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