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ORIGINAL RESEARCH article

Front. Bioeng. Biotechnol.
Sec. Industrial Biotechnology
Volume 12 - 2024 | doi: 10.3389/fbioe.2024.1461253

A new strategy in bioreactor scale-up and process transfer using a dynamic initial vvm according to different aeration pore size

Provisionally accepted
Huaping Ding Huaping Ding 1Zhenggang Xie Zhenggang Xie 2*Siti Aisyah Mualif Siti Aisyah Mualif 1*Huanghe Cheng Huanghe Cheng 2Jiaxian Wu Jiaxian Wu 3Fan Zhang Fan Zhang 3Can Cao Can Cao 2
  • 1 School of Biomedical Engineering & Health Sciences, Faculty of Engineering, University of Technology Malaysia, Johor Bahru, Malaysia
  • 2 T&J Bio-engineering (Shanghai) Co., Ltd., Department of Biosciences, Faculty of Sciences, University Technology Malaysia, johor, Malaysia
  • 3 Dartsbio Pharmaceuticals Ltd., School of Biomedical Engineering & Health Sciences, Faculty of Engineering, University of Technology Malaysia, Johor Bahru, Malaysia

The final, formatted version of the article will be published soon.

    Monoclonal antibody drugs have grown into a drug category with a market size of over $100 billion since the first product was launched on the market, which naturally creates a large demand for production. At the same time, the $100 billion market is distributed among more than 200 listed drugs, which indicates that the production demand for monoclonal antibody drugs is diverse. To meet this demand, major suppliers offer single-use bioreactors of all sizes. These single-use bioreactors with different specifications, especially the inconsistency of aeration pore sizes, pose great challenges for technology transfer and scale-up production, and the conventional scale-up strategies of constant Power input/volume ratio (P/V) and constant vessel volume per minute (vvm) can no longer meet the needs. This study simplified the selection of technical parameters in bioreactors based on the differences in aeration pore size. Innovatively combined the aeration pore sizes with initial aeration vvm, and comprehensively investigated the relationship between P/V, vvm and aeration pore size by designing experiments (DoE) using the orthogonal test method. The results showed a quantitative relationship between the aeration pore size and the initial aeration vvm in the P/V range of 20±5 W/m 3 . The appropriate initial aeration was between 0.01-0.005 m 3 /min for aeration pore size ranging from 1 mm to 0.3 mm, which was the optimal incubation condition in the bioreactors. The choice of initial ventilation was

    Keywords: Scale-up, Cho, Aeration pore size, Initial ventilation volume, VVM

    Received: 08 Jul 2024; Accepted: 26 Aug 2024.

    Copyright: © 2024 Ding, Xie, Mualif, Cheng, Wu, Zhang and Cao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Zhenggang Xie, T&J Bio-engineering (Shanghai) Co., Ltd., Department of Biosciences, Faculty of Sciences, University Technology Malaysia, johor, 81310, Malaysia
    Siti Aisyah Mualif, School of Biomedical Engineering & Health Sciences, Faculty of Engineering, University of Technology Malaysia, Johor Bahru, Malaysia

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.