Cell line development constitutes an important first step in the manufacturing of biotherapeutic drugs. Chinese hamster ovary (CHO) cells represent the most widely used host cell line for production of a variety of complex biotherapeutic drugs. Obtaining a commercially viable and yet robust and high performance CHO cell line is a very critical process and depends on several factors such as achieving consistent growth profiles and desired product quality. These factors can make meeting increasingly shortened timelines challenging with the conventional shake flask based cell line development workflow as it takes several months before a stable clone can be attained, thereby significantly delaying product delivery. With the advent of new automation technologies, now it is possible to implement a high throughput automation platform which not only allows significantly shortened timeline by using parallel processing but also allows notably increased final clone quality. We custom created an automated cell line development platform by combining an automated liquid handling system with an automated bioreactor system to perform cell passaging and production in deep well plates and spin tubes and substantially reduced timeline for cell line screening and clone selection. We performed cell culture suitability assessment using different culture vessels and cell lines as well as production suitability assessment using various validated protein products and achieved improved production performance in addition to much reduced overall cost and manual labor involvement. Automated systems demonstrated here can be used in the biotherapeutic drugs manufacturing process for the collection of immense quantities of cell culture data thereby allowing a rapid, cost-efficient, and a minimal labor requirement approach for cell line engineering and clone selection.

Cell line development strategies using a high throughput automated platform

2019 Spring National Meeting

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