On-Demand Webinar

Improvement of Cell-Freezing Technologies and Disposable Bioreactors: Toward a Fully Closed USP Process

Duration: 1 Hour
Speaker: Aurore Lahille, New Technology Supervisor, Biodevelopment, MilliporeSigma

Abstract: Biotech processes still contain a number of open and at risk transfer steps including the cell culture step when transferring from a frozen vial to containers such as shake flasks. This critical expansion step may take several days or weeks and can delay development or production timelines due to contamination. In order to mitigate risk, a study on bag freezing conditions and the scalability of single-use bioreactors (SUB) was performed coupling traditional technologies and new technologies (disposable bags, cases and bioreactor), in order to define a fully-closed USP process. This study evaluated cells in bags in a fully-closed operation for freezing, thawing and inoculation in a 1250 L bioreactor. The first trial of seven different CHO cell lines was performed, demonstrating the feasibility of this approach. This method was combined with SUBs commonly used for process development and as seeding or production bioreactors. From 2010 to 2013, a study was conducted to evaluate the performance of SUBs at various scales from 3 L to 200 L. This evaluation was performed for seeding applications and clinical material production. Several clinical runs at 200 L and 1250 L were completed to ensure a meaningful comparison. In addition, glass and stainless steel bioreactors of different sizes ranging from 3.6 L to 1250 L were compared. This presentation discusses how to develop a fully-closed USP process by coupling cell freezing in bags and single-use bioreactors up to production scale.

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