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Amanullah, A., Otero, J.M., Mikola, M., Hsu, A., Zhang, J., Aunins, J., Schreyer, B.H., Hope, J.A. and Russo, P.A. (2010) Novel micro-bioreactor high throughput technology for cell culture process development: Reproducibility and scalability assessment of fed-batch CHO cultures. Biotechnology Bioengineering, 106, 57-67.

has been cited by the following article:

• TITLE: Assessment of AMBRTM as a model for high-throughput cell culture process development strategy

  AUTHORS: Sarath Moses, Matthew Manahan, Alexandre Ambrogelly, Wai Lam W. Ling

  KEYWORDS: Microbioreactors; High-Throughput; DoE; Process Ranging; Process Development; Cell Culture

  JOURNAL NAME: Advances in Bioscience and Biotechnology, Vol.3 No.7, November 28, 2012

  ABSTRACT: The development and delivery of high quality therapeutic products necessitates the need for highthrough-put (HTP) process development tools. Traditionally, these works requires a combination of shake flask and small-scale stirred tank bioreactor (STR) which are labor and resource intensive and time-consuming. Here we demonstrate a strategy for rapid and robust cell culture process development by evaluating and implementing the use of a new HTP disposable micro bioreactor (MBR) called AMBRTM system (Advanced Microscale Bioreactor) that has the capabilities for automated sampling, feed addition, pH, dissolved oxygen (DO), gassing and agitation controls. In these studies the performance of two monoclonal antibody (MAb) producing cell lines (MAb1 and MAb2) was evaluated both in the AMBR system and 3-L STR. We demonstrated that cell culture performance (growth and viability, production titer and product quality) were similar in both vessel systems. Furthermore, process control and feed optimization were demonstrated in an additional cell line (MAb3) in the disposable MBR and its performance confirmed at STR scale. The results indicate that the AMBR system can be used to streamline the process development effort and facilitate a rapid and robust cell culture process development effort for MAb programs in a HTP manner.