Tuesday, 19. October 2021 | 13:30 - 14:00

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«Mini-Monoplant Technology for Pharmaceutical Manufacturing»

Dominique M. Roberge, Brendon J. Doyle*, Petteri Elsner, Bernhard Gutmann, Olivier Hannaerts, Christof Aellig, and Arturo Macchi* API Development Services, Lonza AG, Visp, Switzerland, and *Department of Chemical and Biological Engineering, University of Ottawa, Ottawa, Canada dominique.roberge@lon

Pharmaceutical production has historically relied on multipurpose batch vessels in order to produce material through scheduled production campaigns. Although this method is flexible, it is becoming less effective in addressing the changing landscape of pharmaceutical production, where more complex and potent molecules are required to be produced more rapidly and can have fluctuations in their demand.

This presentation describes a method for developing intensified and dedicated pharmaceutical processes, known as mini-monoplants. Key value-generating aspects are described at each stage of development, from lab-based development of best-in-class processes to factory-based development for an accelerated time to market and finally to mini-monoplant technology for production at commercial scale.

The road to development of a mini-monoplant for pharmaceutical production occurs through three main stages, namely, lab-based development, factory-based development, and mini-monoplant production at the commercial scale. In lab-based development, miniplant process development occurs within the safety of a laboratory, where chemists and engineers can focus on valuegenerating features such as novel reaction pathways, intensified reactors, automation, and dedication. Here, novel and innovative continuous processes can be developed with a small footprint with throughputs that can span from 1 to 50 kg of product per day. Upon completion of the lab-scale development, the miniplant can then be moved to an available cabin within the existing plant infrastructure, allowing for access to large-volume feed and product storage tanks. This provides a similar flexibility as was available in the laboratory, and the usage of predesigned (and potentially GMP-prequalified) multipurpose unit operation modules can greatly reduce the development time and time to market for introducing new technology into the pharmaceutical production process. The first stage of process scale-up occurs in factory-based development, where throughputs can be increased to meet the demands of clinical trials. Finally, when the product has gone commercial, dedicated production assets can be acquired, and the process can be installed in a designated area within the plant. It is at this stage that the process can be considered a minimonoplant, and the final temporal scale-up occurs with respect to the overall operating time of the process, of which dedication allows year-round operation if required in order to meet fluctuations and uncertainty in product demand.

As this processing mode becomes more commonly adopted, it is expected these technologies will develop and become more readily available, especially when/if regulatory and tax incentives that can help address the financial hesitation toward widespread adoption of novel technologies becomeavailable.

 

[1] B.J. Doyle, P. Elsner, B. Gutmann, O. Hannaerts, C. Aellig, A. Macchi,* and D.M. Roberge, Organic Process Research & Development, 2020, 24, 2169-2182.

 

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