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A dynamic design space for primary drying during batch freeze-drying

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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.

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Chicago
Mortier, Séverine, Pieter-Jan Van Bockstal, Ingmar Nopens, Thomas De Beer, and Krist V Gernaey. 2016. “A Dynamic Design Space for Primary Drying During Batch Freeze-drying.” Chimica Oggi-chemistry Today 34 (3): 59–61.
APA
Mortier, Séverine, Van Bockstal, P.-J., Nopens, I., De Beer, T., & Gernaey, K. V. (2016). A dynamic design space for primary drying during batch freeze-drying. CHIMICA OGGI-CHEMISTRY TODAY, 34(3), 59–61.
Vancouver
1.
Mortier S, Van Bockstal P-J, Nopens I, De Beer T, Gernaey KV. A dynamic design space for primary drying during batch freeze-drying. CHIMICA OGGI-CHEMISTRY TODAY. 2016;34(3):59–61.
MLA
Mortier, Séverine, Pieter-Jan Van Bockstal, Ingmar Nopens, et al. “A Dynamic Design Space for Primary Drying During Batch Freeze-drying.” CHIMICA OGGI-CHEMISTRY TODAY 34.3 (2016): 59–61. Print.
@article{8511731,
  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.},
  author       = {Mortier, S{\'e}verine and Van Bockstal, Pieter-Jan and Nopens, Ingmar and De Beer, Thomas and Gernaey, Krist V},
  issn         = {0392-839X},
  journal      = {CHIMICA OGGI-CHEMISTRY TODAY},
  language     = {eng},
  number       = {3},
  pages        = {59--61},
  title        = {A dynamic design space for primary drying during batch freeze-drying},
  volume       = {34},
  year         = {2016},
}

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