Performance of hybridoma cell culture in a computer-controoled research-scale to pilot-scale hollow-fiber bioreactor system

摘要

Scientists faced with the task of investigating hollow-fiber systems with new hybridomas and developing scaleable protocols for producing monoclonal antibodies (MAb) were dependent on manual systems through the research and pilot stages. Only when the process reached production scale was some level of automation available. This usually resulted in either a production protocol that mimicked manual procedures or a lengthy adaptation or revalidation of the method to take advantage of the automation, monitoring, and control processes that are available in production systems and are required for Good Manufacturing Practice (GMP) production.