Developing Mammalian Cell Culture Capabilities for Process Science at Ajinomoto Althea, Inc.

This Spring 2017 Semester-in- Residence was conducted at Ajinomoto Althea, Inc. in the Process Science department located in San Diego, CA. Ajinomoto Althea, Inc. (also known as, “Althea”) is a contract manufacturing organization known for providing clinical and commercial product development services (Althea, 2015). In recent years, the company has expanded its services; however, Althea still does not have the capability to take on mammalian cell culture services due to a lack of necessary infrastructure. The project goal of this Semester-in- Residence was to determine the equipment needed to commission a new laboratory for the Process Science department, design a floor map with the proposed equipment, use a cost-profit analysis to determine the profitability of adding on this new service and to map the capabilities of scaling up. This project establishes the necessary framework and infrastructure needed for Althea to expand its cell culture services, and will also position the company to move forward with the ability to take on new and more diverse clients. Determining the equipment needed for such an expansion and designing a layout that meets Althea’s needs demanded a high level of familiarity with mammalian cell culture labs. To establish this familiarity it was necessary to work with experienced professionals in existing culture labs, and meet with vendors to obtain quotes and gain more knowledge about the equipment that will be routinely used by the lab. The cost-profit analysis that was conducted relied heavily on consultation with financial experts, and the results of this analysis illustrated the profitability of this mammalian cell culture laboratory. With the addition of a Process Science mammalian cell culture laboratory, Althea will be required to grow with regards to personnel and physical laboratory space in order to later establish the extension of Technology Transfer (TT) and a Good Manufacturing Practices (GMP) facility. Future implications involve more work and research to further scale-up the process established in this project. Althea will need to take on a client in the Process Development scale, establish the client process and perform evaluations on different larger bioreactors before purchasing equipment for scale up. However, in order for Althea to stay competitive and progress in the biotechnology industry, it will be necessary for Althea to establish mammalian cell culture capabilities.