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Looking inside the ‘black box’: Freezing engineering to ensure the quality of freeze-dried biopharmaceuticals

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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Looking inside the ‘black box’: Freezing engineering to ensure the quality of freeze-dried biopharmaceuticals. / Capozzi, Luigi C.; Pisano, Roberto.
In: European Journal of Pharmaceutics and Biopharmaceutics, Vol. 129, 01.08.2018, p. 58-65.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Capozzi, LC & Pisano, R 2018, 'Looking inside the ‘black box’: Freezing engineering to ensure the quality of freeze-dried biopharmaceuticals', European Journal of Pharmaceutics and Biopharmaceutics, vol. 129, pp. 58-65. https://doi.org/10.1016/j.ejpb.2018.05.020

APA

Capozzi, L. C., & Pisano, R. (2018). Looking inside the ‘black box’: Freezing engineering to ensure the quality of freeze-dried biopharmaceuticals. European Journal of Pharmaceutics and Biopharmaceutics, 129, 58-65. https://doi.org/10.1016/j.ejpb.2018.05.020

Vancouver

Capozzi LC, Pisano R. Looking inside the ‘black box’: Freezing engineering to ensure the quality of freeze-dried biopharmaceuticals. European Journal of Pharmaceutics and Biopharmaceutics. 2018 Aug 1;129:58-65. doi: 10.1016/j.ejpb.2018.05.020

Author

Capozzi, Luigi C. ; Pisano, Roberto. / Looking inside the ‘black box’ : Freezing engineering to ensure the quality of freeze-dried biopharmaceuticals. In: European Journal of Pharmaceutics and Biopharmaceutics. 2018 ; Vol. 129. pp. 58-65.

Bibtex

@article{a2eeeb3003d74e92b5680a5c51031dee,
title = "Looking inside the {\textquoteleft}black box{\textquoteright}: Freezing engineering to ensure the quality of freeze-dried biopharmaceuticals",
abstract = "The freezing step plays a central role in reaching the most stringent requirements of quality, homogeneity and standardization of freeze-dried products. In this paper, a systematic procedure has been proposed to obtain a quantitative estimation of the pore-size variability of lyophilized products resulting from uncontrollable variations of the nucleation temperature. This procedure consisted in collecting the nucleation temperature from a statistically significant number of samples and correlating each nucleation temperature to the corresponding product morphology, using a mathematical model, to obtain a statistical description of the lyophilized product structure. This approach can also be used to obtain an estimation of the variability of the mass transfer resistance to vapor flow and, finally, of the drying time. Two different freezing configurations, i.e., conventional and suspended-vial freezing, have been used as case studies since they can produce significantly different freezing rates.",
keywords = "Freeze-drying, Freezing, Ice nucleation, Lyophilization, Mass transfer resistance, Uncertainty",
author = "Capozzi, {Luigi C.} and Roberto Pisano",
year = "2018",
month = aug,
day = "1",
doi = "10.1016/j.ejpb.2018.05.020",
language = "English",
volume = "129",
pages = "58--65",
journal = "European Journal of Pharmaceutics and Biopharmaceutics",
issn = "0939-6411",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Looking inside the ‘black box’

T2 - Freezing engineering to ensure the quality of freeze-dried biopharmaceuticals

AU - Capozzi, Luigi C.

AU - Pisano, Roberto

PY - 2018/8/1

Y1 - 2018/8/1

N2 - The freezing step plays a central role in reaching the most stringent requirements of quality, homogeneity and standardization of freeze-dried products. In this paper, a systematic procedure has been proposed to obtain a quantitative estimation of the pore-size variability of lyophilized products resulting from uncontrollable variations of the nucleation temperature. This procedure consisted in collecting the nucleation temperature from a statistically significant number of samples and correlating each nucleation temperature to the corresponding product morphology, using a mathematical model, to obtain a statistical description of the lyophilized product structure. This approach can also be used to obtain an estimation of the variability of the mass transfer resistance to vapor flow and, finally, of the drying time. Two different freezing configurations, i.e., conventional and suspended-vial freezing, have been used as case studies since they can produce significantly different freezing rates.

AB - The freezing step plays a central role in reaching the most stringent requirements of quality, homogeneity and standardization of freeze-dried products. In this paper, a systematic procedure has been proposed to obtain a quantitative estimation of the pore-size variability of lyophilized products resulting from uncontrollable variations of the nucleation temperature. This procedure consisted in collecting the nucleation temperature from a statistically significant number of samples and correlating each nucleation temperature to the corresponding product morphology, using a mathematical model, to obtain a statistical description of the lyophilized product structure. This approach can also be used to obtain an estimation of the variability of the mass transfer resistance to vapor flow and, finally, of the drying time. Two different freezing configurations, i.e., conventional and suspended-vial freezing, have been used as case studies since they can produce significantly different freezing rates.

KW - Freeze-drying

KW - Freezing

KW - Ice nucleation

KW - Lyophilization

KW - Mass transfer resistance

KW - Uncertainty

U2 - 10.1016/j.ejpb.2018.05.020

DO - 10.1016/j.ejpb.2018.05.020

M3 - Journal article

C2 - 29787801

AN - SCOPUS:85047244012

VL - 129

SP - 58

EP - 65

JO - European Journal of Pharmaceutics and Biopharmaceutics

JF - European Journal of Pharmaceutics and Biopharmaceutics

SN - 0939-6411

ER -