UNICAN: Dual capability in single use bioreactors

Disposable technology is being used more each year in the biotechnology industry. Disposable bioreactors allow one to avoid expenses associated with cleaning, assembly and operations, as well as equipment validation. However, one of the biggest challenges for single use technology including single use bioreactors is the single sourcing of consumables. Typically, the consumables are tied to the hardware eliminating the flexibility and interchangeability among existing systems, which ultimately forces the end user to rely on a single vendor’s supply chain. In order to address this challenge, a 200L bottom mounted single-use bioreactor was converted into a universal can, or “Unican”, which supports the use of both bottom mounted agitator and top mounted agitator single use bioreactors. The implementation of Unican increases flexibility for cell culture operations improves assurance of supply, allows handling of any bag film changes/issues in future and reduces the dependence on single suppliers. As part of the project, mass transfer and cell culture experiments were performed to ensure optimal performance of both bags in the Unican. Cell Culture data and mass transfer were shown to be comparable in both top and bottom mounted bags with historical data. Additionally, the modification of the system was performed such that no hardware requalification was required post[1]modification. The system has been successfully implemented in a pilot plant for bioprocessing.

Presented by Ekta Mahajan, Sr. Principal Material Science Engineer at Genentech

Ekta Mahajan is Sr. Principal Material Science Engineer at Genentech/Roche in South San Francisco, CA. Ekta has 19 years of industry experience, with 15 years in process development, three patent applications, and 10 external publications.  In her regulatory role, she led the technical regulatory team for the global filing of an initial market application for the first Genentech fixed dose combination monoclonal antibody and leads a global clinical and CMC regulatory team to support product optimization.  Prior to regulatory, she has fifteen years of experience in research and manufacturing experience in biotechnology, vaccines and pharmaceuticals, and lead projects in a wide range of areas, both upstream and downstream, including commercial manufacturing support, process development, and new technology evaluations. Ekta has expertise in disposable technology and is a recognized expert and thought leader in single-use technology both within Genentech and Roche and across industry groups.

Before joining Genentech, Ekta was a process engineer at Merck, working on vaccines and process operations. Ekta was a process engineer at Merck, working on vaccines and process operations. She holds Chemical Engineering degrees from the Thapar Institute of Engineering and Technology, Punjab, India (Bachelor’s) and Bucknell University, Pennsylvania (Master’s).