Single-use bioreactors are now being routinely employed for CHO cell line-based biologics manufacturing. We have previously demonstrated the use of a scale-up platform in 200 and 2000 L-scale SUBs (ACS Spring 2017) for FIH processes. Since then, an integrated cell line development, process development and clinical manufacturing paradigm has been used for many Selexis cell lines (Selexis-KBI integrated approach), which leads to completion of the first FIH clinical manufacturing batch within 11 months after transfection. This work will show scale-up results for several new molecules using our platform cell culture process highlighting two types of project paradigms: 1) rapid commercialization of CHO cell culture processes and 2) impact of high titer cell culture processes on bioreactor volume and process duration. Constant factors for scale-up such as power per volume input, kLa and volumetric gas flow rates are applied to move processes from ambr15 to 2000 L-scale SUBs. Based on this analysis, we have further improved our record of seamless scale-up in single-use systems for clinical products and shown the ability to support commercial launch of new biologics.

Clinical and commercial-launch process scalability in a single-use bioreactor platform

2019 Spring National Meeting

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