Abstract
Biopharmaceutical products are emerging within the pharmaceutical industry. However, biopharmaceuticals are often unstable in aqueous solution. Freeze-drying (lyophilisation) is the preferred method to achieve a stable product with an increased shelf-life. During batch freeze-drying, there are only two adaptable process variables, i.e. the shelf temperature and the pressure in the drying chamber. The value of both should be optimized, preferably in a dynamic way, to minimise the primary drying time while respecting process and equipment constraints and ensuring end product quality. A mechanistic model is used to determine the optimal values for the adaptable variables, hereby accounting for the uncertainty in all involved model parameters. A dynamic Design Space was constructed with a risk of failure acceptance level of 0.01%, i.e. a 'zero-failure' situation. Even for a risk of failure of 0.01%, the computed settings resulted in a reduction of the drying time by over 50% compared to current practice.
Original language | English |
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Journal | Chimica Oggi |
Volume | 34 |
Issue number | 3 |
Pages (from-to) | 59-61 |
Number of pages | 3 |
ISSN | 0392-839X |
Publication status | Published - 2016 |
Keywords
- Dynamic Design Space
- Freeze-drying
- Mathematic modeling