Development of a novel continuous filtration unit for pharmaceutical process development and manufacturing

Sara Ottoboni; Chris J. Price; Christopher Steven; Elizabeth Meehan; Alastair Barton; Paul Firth; Andy Mitchell; Furqan  Tahir

doi:10.1016/j.xphs.2018.07.005

Development of a novel continuous filtration unit for pharmaceutical process development and manufacturing

Sara Ottoboni, Chris J. Price, Christopher Steven, Elizabeth Meehan, Alastair Barton, Paul Firth, Andy Mitchell, Furqan Tahir

Research output: Contribution to journal › Article

2 Citations (Scopus)

Abstract

The lack of a commercial laboratory, pilot and small manufacturing scale dead end continuous filtration and drying unit it is a significant gap in the development of continuous pharmaceutical manufacturing processes for new active pharmaceutical ingredients (APIs). To move small-scale pharmaceutical isolation forward from traditional batch Nutsche filtration to continuous processing a continuous filter dryer prototype unit (CFD20) was developed in collaboration with Alconbury Weston Ltd. The performance of the prototype was evaluated by comparison with manual best practice exemplified using a modified Biotage VacMaster unit to gather data and process understanding for API filtration and washing. The ultimate objective was to link the chemical and physical attributes of an API slurry with equipment and processing parameters to improve API isolation processes. Filtration performance was characterized by assessing filtrate flow rate by application of Darcy's law, the impact on product crystal size distribution and product purity were investigated using classical analytical methods. The overall performance of the 2 units was similar, showing that the prototype CFD20 can match best manual lab practice for filtration and washing while allowing continuous processing and real-time data logging. This result is encouraging and the data gathered provides further insight to inform the development of CFD20.

Language	English
Pages	372-381
Number of pages	10
Journal	Journal of Pharmaceutical Sciences
Volume	108
Issue number	1
Early online date	6 Sep 2018
DOIs	10.1016/j.xphs.2018.07.005
Publication status	Published - 31 Jan 2019

Fingerprint

Drug products

Pharmaceutical Preparations

Washing

Processing

Practice Guidelines

Drying

Flow rate

Equipment and Supplies

Crystals

Keywords

continuous filtration
washing
drying
agglomeration
impurity
optimisation

Cite this

Ottoboni, S., Price, C. J., Steven, C., Meehan, E., Barton, A., Firth, P., ... Tahir, F. (2019). Development of a novel continuous filtration unit for pharmaceutical process development and manufacturing. Journal of Pharmaceutical Sciences, 108(1), 372-381. https://doi.org/10.1016/j.xphs.2018.07.005

Ottoboni, Sara ; Price, Chris J. ; Steven, Christopher ; Meehan, Elizabeth ; Barton, Alastair ; Firth, Paul ; Mitchell, Andy ; Tahir, Furqan . / Development of a novel continuous filtration unit for pharmaceutical process development and manufacturing. In: Journal of Pharmaceutical Sciences. 2019 ; Vol. 108, No. 1. pp. 372-381.

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abstract = "The lack of a commercial laboratory, pilot and small manufacturing scale dead end continuous filtration and drying unit it is a significant gap in the development of continuous pharmaceutical manufacturing processes for new active pharmaceutical ingredients (APIs). To move small-scale pharmaceutical isolation forward from traditional batch Nutsche filtration to continuous processing a continuous filter dryer prototype unit (CFD20) was developed in collaboration with Alconbury Weston Ltd. The performance of the prototype was evaluated by comparison with manual best practice exemplified using a modified Biotage VacMaster unit to gather data and process understanding for API filtration and washing. The ultimate objective was to link the chemical and physical attributes of an API slurry with equipment and processing parameters to improve API isolation processes. Filtration performance was characterized by assessing filtrate flow rate by application of Darcy's law, the impact on product crystal size distribution and product purity were investigated using classical analytical methods. The overall performance of the 2 units was similar, showing that the prototype CFD20 can match best manual lab practice for filtration and washing while allowing continuous processing and real-time data logging. This result is encouraging and the data gathered provides further insight to inform the development of CFD20.",

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Ottoboni, S , Price, CJ, Steven, C, Meehan, E, Barton, A, Firth, P, Mitchell, A & Tahir, F 2019, 'Development of a novel continuous filtration unit for pharmaceutical process development and manufacturing' Journal of Pharmaceutical Sciences, vol. 108, no. 1, pp. 372-381. https://doi.org/10.1016/j.xphs.2018.07.005

Development of a novel continuous filtration unit for pharmaceutical process development and manufacturing. / Ottoboni, Sara ; Price, Chris J.; Steven, Christopher; Meehan, Elizabeth; Barton, Alastair; Firth, Paul; Mitchell, Andy; Tahir, Furqan .

In: Journal of Pharmaceutical Sciences, Vol. 108, No. 1, 31.01.2019, p. 372-381.

Research output: Contribution to journal › Article

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