Evaluation of the advanced micro-scale bioreactor (ambr™) as a highthroughput tool for cell culture process development

Abstract

Bio-pharmaceutical industries face an increasing demand to accelerate process development and reduce costs. This challenge requires high throughput tools to replace the traditional combination of shake flasks and small-scale stirred tank bioreactors. A conventional and widely used process development tool is the stirred tank reactor (STR) ranging from approximately 1L to 10L in working volume. Physical culture parameters such as pH, temperature and pO2 can be easily controlled in such systems. However preparation and operation of these systems are time and resource consuming. The ambr™ system from TAP Biosystems has the capabilities for automated sampling, feed addition, and control for pH, dissolved oxygen, gassing, agitation, and temperature. Here, through the evaluation of parameters including cell growth, viability, metabolite concentration and production titer during a fed-batch process using CHO cells producing a recombinant mAb, we assessed the reproducibility of the ambr™ system for standard conditions compared to 2L stirred tank bioreactors and the effects of parameter ranging between both culture systems, namely feed rate and pH ranging.