KUBiobox: Filling the current gap in viral vector manufacturing

The industry is experiencing significant growth in cell and gene therapies, fueled by positive clinical results. This growth has created a shortage in manufacturing capacity. Speed, flexibility, and potential for future expansion are key elements of a solution. A modular approach with KUBio box, which incorporates a single-use environment, can help to advance and accelerate access to these life saving therapeutics.

Speaker:
Ellen Johnson, Enterprise Solutions Technology Leader, Cytiva

In Ellen’s role, she identifies new internal and external technologies for incorporation into next generation Enterprise Solutions FlexFactoryᵀᴹ and KUBio offerings. Prior to joining the GE Healthcare’s Life Sciences business, now Cytiva, Ellen held various process engineering and management roles at Amgen, Inc. She progressed the next generation (single-use) mAb manufacturing platform through design and implementation of innovative technologies related to equipment, automation and consumables. She also developed and maintained corporate (stainless steel) mAb manufacturing platform defining best practices related to process and equipment and participated in new plant start-up activities. She and her teams supported process development, characterization, transfer, validation and monitoring activities. She has acted as process team leader as well as lead process engineer for an entire microbial drug substance process. Additionally, she has authored portions of CMC regulatory submissions and responses to filing questions and inspection observations and presented to auditors from various jurisdictions.