Liaison(s): Jennifer Ton Tom Kawata
Allergan, Inc. is a global multi-specialty health care company focused on discovering, developing, and commercializing innovative pharmaceuticals, biologics, and medical devices. Founded over 60 years ago in 1948 and headquartered in Irvine, Allergan’s portfolio includes ophthalmic pharmaceuticals, neurological therapeutics, and cosmetic products. Allergan relies on microbial fermentation to produce various biologics, typically using large stainless steel fermenters. Allergan would like to test the production capability and economic feasibility of new disposable bioreactor technology that has been adapted for microbial expression systems. The use of a disposable system might create value by lowering costs and time associated with system validations in addition to improving safety and ergonomic outcomes. The Allergan TMP Team was asked to evaluate the performance of a disposable bioreactor technology and develop a cost/benefit analysis which compares these systems to the typical stainless steel systems. To accomplish this goal, the team conducted cell-free testing which characterized the capabilities and limitations of a new, first of its kind, modified single use bioreactor and compared this system to a commercially available system. After analyzing the initial data and establishing optimal microbial fermentation parameters achieved with the new system, the Allergan TMP Team conducted several fermentation runs with E.coli and P.pastoris. Protein yields were analyzed and served as a basis for the economic evaluation of a disposable system. To develop an economic model, the Allergan TMP team analyzed the system productivity as well as variable and partial fixed costs in addition to safety and ergonomic issues. Upon completion of this project, Allergan will be able to assess the economic value and commercial potential of disposable fermentation technology in comparison to the stainless steel standard systems.