Single-use technology has been widely adopted in the biopharmaceutical industry. Results from a 2015 survey reported in BioPharm International show that 87% of respondents to a “manufacturing trends and outlook” survey reported using single-use components in their processes[1]. Despite the wide adoption of single-use technology, the availability of hands-on training opportunities, particularly those that incorporate an actual bioprocess, are limited.
This is the first phase of a larger project that will assemble the single-use equipment and develop a process for monoclonal antibody (mAb) production in CHO to be used for education/training and development projects. The project would lead to the first dedicated single-use mAb production process for education, training, testing and development of which we are aware.
[1] R. Peters, "Technologies and Practices Must Evolve to Meet Demand,” BioPharm International, Vol 28 (1) 2015
· A single-use process for producing monoclonal antibody (mAb) VRCO1 using a CHO cell line at 50 L bioreactor scale has been developed. The process will be used to support courses and to provide a test bed for process and analytical technologies being developed for mAb production.
· The upstream portion of the hands-on short course (for professionals) Single-use Processing for mAbs was developed. The downstream portion of the course will be developed as part of phase 2 of the project.
· A single-use chromatography system (Mobius FlexReady Solution for Chromatography with Smart Flexware Assemblies (XM02)) was procured in preparation for development of a single-use downstream process (harvest, purification and bulk fill) of the mAb VRC01 to complete the mAb production process. Downstream development will be undertaken as part of phase 2 of this project.
The Single-use Processing for mAbs course will become a part of BTEC’s existing short course program, which has trained nearly 4000 industry professionals since its inception in 2009. We expect that this course will be offered at least annually well into the future.
Development of the first dedicated single-use mAb production process for education, training, testing and development
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North Carolina State University
