Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT)

Aksu, Buket; Beer, Thomas De; Folestad, Staffan; Ketolainen, Jarkko; Lindén, Hans H.; Lopes, João A.; Matas, Marcel de; Oostra, W.; Rantanen, Jukka; Weimer, Marco

doi:10.1016/j.ejps.2012.06.009

Cited by 54 publications

(26 citation statements)

References 11 publications

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“…Furthermore, after the optimization problem is solved based on the MOM model, the full CSD can be recovered by solving the full model of eqs. (8) and (9). In such a way, less-expensive function evaluations are possible for the optimization algorithms 24 .…”

Section: Mathematical Modelling Of Plug-flow Crystallizermentioning

confidence: 99%

“…Over the last decade, the development of continuous manufacturing and purification processes, particularly crystallization, has mainly focused on the modification of existing batch units [8][9][10] , in addition to studying innovative equipment design. Batch crystallizers are often based around stirred-tank technologies, which can be converted to continuous mode as multi-stage mixed-suspension and mixed product removal (MSMPR) operations [11][12][13][14][15][16] , but they suffer from broad residence time distributions, leading to broad crystal size distributions and problems in downstream processes, such as filtration, isolation, drying and solids mixing.…”

Section: Introductionmentioning

confidence: 99%

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Mathematical Modeling, Design, and Optimization of a Multisegment Multiaddition Plug-Flow Crystallizer for Antisolvent Crystallizations

Benyahia

Nagy

et al. 2015

Org. Process Res. Dev.

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Just Accepted "Just Accepted" manuscripts have been peer-reviewed and accepted for publication. They are posted online prior to technical editing, formatting for publication and author proofing. The American Chemical Society provides "Just Accepted" as a free service to the research community to expedite the dissemination of scientific material as soon as possible after acceptance. "Just Accepted" manuscripts appear in full in PDF format accompanied by an HTML abstract. "Just Accepted" manuscripts have been fully peer reviewed, but should not be considered the official version of record. They are accessible to all readers and citable by the Digital Object Identifier (DOI®). "Just Accepted" is an optional service offered to authors. Therefore, the "Just Accepted" Web site may not include all articles that will be published in the journal. After a manuscript is technically edited and formatted, it will be removed from the "Just Accepted" Web site and published as an ASAP article. Note that technical editing may introduce minor changes to the manuscript text and/or graphics which could affect content, and all legal disclaimers and ethical guidelines that apply to the journal pertain. ACS cannot be held responsible for errors or consequences arising from the use of information contained in these "Just Accepted" manuscripts. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2 TABLE OF CONTENTS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 The configuration in which anti-solvent could be added at a variety of different locations along the tube length and at optimal flow rates was able to outperform previous designs in the literature which considered equally-spaced anti-solvent additions. The use of dynamic models to detect problems during startup of an MSMA-PFC was also highlighted.

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Section: Mathematical Modelling Of Plug-flow Crystallizermentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Mathematical Modeling, Design, and Optimization of a Multisegment Multiaddition Plug-Flow Crystallizer for Antisolvent Crystallizations

Benyahia

Nagy

et al. 2015

Org. Process Res. Dev.

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“…In the spirit of the QbD (Quality by Design) methodology (Aksu et al, 2012;Loh et al, 2015;Rathore, 2016), a detailed mapping of the parametric space has been performed in order to identify the sensitivity of the milling kinetics (the time evolution of the particle size distribution) on the design and process parameters, and to use this knowledge for scale-up from batch to flow-trough process.…”

Section: Accepted M Manuscriptmentioning

confidence: 99%

Scale-up from batch to flow-through wet milling process for injectable depot formulation

Lehocký

Pěček²,

Štěpánek

2016

European Journal of Pharmaceutical Sciences

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Injectable depot formulations are aimed at providing long-term sustained release of a drug into systemic circulation, thus reducing plasma level fluctuations and improving patient compliance. The particle size distribution of the formulation in the form of suspension is a key parameter that controls the release rate. In this work, the process of wet stirred media milling (ball milling) of a poorly water-soluble substance has been investigated with two main aims: (i) to determine the parametric sensitivity of milling kinetics; and (ii) to develop scaleup methodology for process transfer from batch to flow-through arrangement. Ball milling experiments were performed in two types of ball mills, a batch mill with a 30 ml maximum working volume, and a flow-through mill with a 250 ml maximum working volume. Milling parameters were investigated in detail by methodologies of QbD to map the parametric space.Specifically, the effects of ball size, ball fill level, and rpm on the particle breakage kinetics were systematically investigated at both mills, with an additional parameter (flow-rate) in the case of the flow-through mill. The breakage rate was found to follow power-law kinetics with respect to dimensionless time, with an asymptotic d 50 particle size in the range of 200-300 nm.In the case of the flow-through mill, the number of theoretical passes through the mill was found to be an important scale-up parameter.

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“…Guidelines such as ICH Q8, ICH Q9, ICH Q10, ICH Q11 and ICH Q12 published by the International Harmonization Commission (ICH) detail the scientific and innovative design and quality perception required to ensuring consistent product quality [3]. When the literature is examined, while there are a large number of studies [4][5][6][7][8][9][10][11][12] in which QbD and Process Analytical Technology (PAT) applications are analyzed, it is obvious that conducting more research in this area is necessary as the benefits of the field are taken into consideration. The approach of designing pharmaceutical products with quality rather than testing the final product during the pharmaceutical product development process, which is difficult and costly, is a topic that attracts growing interest.…”

Section: Introductionmentioning

confidence: 99%

Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry

2017

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Quality by Design (QbD) for the pharmaceutical industry includes the design, development and production control of products and production processes from the beginning to the end of the product development phase for ensuring the consistent quality of a pharmaceutical product. The QbD is a systematic scientific approach aimed at meeting the needs of the patient in the desired and targeted quality and aiming to produce the same quality pharmaceutical product in this direction. Process Analytical Technology, which is assessed in that regard, is part of a design quality approach that is used to design, analyze, and control real-time measurements of quality and performance criteria for raw and processed materials to achieve the desired final product. This scientific and systematic approach to pharmaceutical product development, which is also acknowledged and supported by the health authorities, serves to the changing and developing pharmaceutical sector.

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Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT)

Cited by 54 publications

References 11 publications

Mathematical Modeling, Design, and Optimization of a Multisegment Multiaddition Plug-Flow Crystallizer for Antisolvent Crystallizations

Mathematical Modeling, Design, and Optimization of a Multisegment Multiaddition Plug-Flow Crystallizer for Antisolvent Crystallizations

Scale-up from batch to flow-through wet milling process for injectable depot formulation

Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry

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