N-mAb

Project status

100% Completed

Solution

The A-mAb case study (2009) created value in the biopharmaceutical industry by bringing industry and regulatory stakeholders together to develop shared expectations and vocabulary for quality by design. Participation included key thought leaders in industry and from relevant federal agencies. NIIMBL is committed to supporting and accelerating the adoption of integrated and continuous processes for manufacturing biopharmaceuticals.

The goal of the N-mAb initiative is to convene thought leaders to establish shared vocabulary and understanding by which the industry can think about integrated/continuous processes with respect to regulatory considerations. Specifically the key deliverable of this project is a published control strategy framework for a hypothetical integrated/continuous monoclonal antibody manufacturing process.

View and download N-mAb at https://niimbl.force.com/s/n-mab.

Impacts

Case study that supports teaching and learning for both industry and regulators around adoption of advanced manufacturing process technologies for mAbs

Publications

Schaefer, G., Balchunas, J., Charlebois, T., Erickson, J., Hart, R., Kedia, S. B., & Lee, K. H. (2023). Driving adoption of new technologies in biopharmaceutical manufacturing. Biotechnology and Bioengineering, 120(9), 2765–2770. https://doi.org/10.1002/bit.28395

Brower, K., Wiltberger, K., Berdugo, C., Bosley, A., Goodrich, E., Pferdeort, V., & Schaefer, G. (2024). Process development and characterization for integrated continuous bioprocesses-Highlights from N-mAb. Biotechnology Progress, , e3425. https://doi.org/10.1002/btpr.3425

Grampp, G., Bosley, A., Qadan, M., Schiel, J., Spasoff, A., Valax, P., & Schaefer, G. (2024). Managing integrated continuous bioprocesses in real time: Deviations in product quality. Biotechnology Progress, 40(2), e3414. https://doi.org/10.1002/btpr.3414