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.
Development of the first dedicated single-use mAb production process for education, training, testing and development.
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.
Single-use Center of Excellence Based on a Simulated-GMP Process for mAb Production (NMBL-002), NIIMBL Member Forum, Virtual, April 23, 2020.
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North Carolina State University
