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Single-use Center of Excellence Based on a Simulated-GMP Process for mAb Production

This project that will assemble single-use equipment and develop a process for monoclonal antibody (mAb) production in CHO to be used for education/training and development projects.
Categories
Proteins/ Antibodies
Drug substance
Equipment and Supplies
Incumbent worker training
Project status
100% Completed

Solution

Performance Period: 2/1/2019 to 12/31/2020

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

Updates, Related Publications, and Deliverables

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Project Lead

North Carolina State University

North Carolina State University