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Following creation of a new cell line, or receipt of an existing cell line, we will begin to establish a program of development and scale-up work that is suitable for transfer to a manufacturing facility. Typical studies at this stage would include selection of a culture medium, definition of an inoculum expansion and production process, including feeding strategies and cell line stability studies. We have experience in developing hundreds of scaleable processes for mammalian production including, CHO, hybridoma, mouse myeloma (NS0) and a variety of human cell lines.
Lonza has made a considerable investment in culture media development programs resulting in the yields of existing cell lines often being significantly improved in Lonza proprietary media. Lonza's new Version 8 Media and Feeds System can expedite cGMP production as specifications of the raw materials and their sourcing are already established as well as significant process optimization to reach 9.6 g/l of intended antibody.
Additional process optimization studies can be performed, if necessary, to meet the requirements of individual customers. Such cell line specific optimization programs are often performed in parallel with early clinical evaluation of the product for our customers using one of Lonza generic platform production processes.
Cell removal is an often ignored area of process development. Lonza has developed scaled-down methodologies that ensure maximum product recovery upon transfer of the process to commercial-scale production. The development team works closely with the manufacturing and quality assurance groups to define and document all new processes and to create robust manufacturing procedures.
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