At Pfizer, ambr15™ has been implemented for use early in the development of monoclonal antibodies in CHO cells. This is consistent with industry trends of using automated, high-throughput platforms to improve process consistency and to accelerate the process development timeline. In this presentation we will highlight several solutions to challenges in developing ambr15™ scale down models for processes that require the use of a high end pH delivery of glucose and high density fed batch culture approaches. Here we compare the cell culture performance using complex control strategies in the ambr15™ reactors to those in the traditional lab scale 2 L vessels and then to 500L, 2500L and 12,000 L to demonstrate the suitability of using these strategies for process development in ambr15™. We applied this technique to at least two different cell lines. Cell culture performance, including growth profiles and product titers, were shown to be comparable across the different scales. Aligning dissolved carbon dioxide profiles of scale down models to manufacturing scale vessels is usually a scale-up challenge, here we applied a gassing strategy in the ambr15™ that closely mimics the large scale dissolved carbon dioxide profiles, and is broadly applicable to multiple cell lines . This works shows that the ambr15™ can be used as a scale down model for processes that use non-standard CHO process control strategies.

Implementing HIPDOG (High end pH controlled delivery of glucose) in the AMBR15 microbioreactor system

253rd National Meeting (2017)

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