Regulatory and Quality Considerations for Continuous Manufacturing

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles L.; Garcia, Tom; Bizjak, Tara Gooen; Holte, Øyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti D.; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

doi:10.1002/9781119001348.ch3

Cited by 25 publications

(31 citation statements)

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“…Pharmaceutical regulatory agencies are driving the industry to adopt quality-by-design (QbD) methods 13,14 to enhance quality and reduce variability. Process cost reductions and maximising operation efficiency are key drivers for change and continuous manufacturing (CM) is widely used to address these challenges in the production of commodity products.…”

Section: Introductionmentioning

confidence: 99%

Enabling precision manufacturing of active pharmaceutical ingredients: workflow for seeded cooling continuous crystallisations

Brown

McGlone

Yerdelen

et al. 2018

Mol. Syst. Des. Eng.

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Section: Introductionmentioning

confidence: 99%

Enabling precision manufacturing of active pharmaceutical ingredients: workflow for seeded cooling continuous crystallisations

Brown

McGlone

Yerdelen

et al. 2018

Mol. Syst. Des. Eng.

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“…Combining portable Raman spectroscopy with dissolution methods opens up opportunities to monitor processes without further sample preparation or aliquot removal. This may have application in the area of monitoring real-time API release [24] using small-footprint spectrometers [25] that can be implemented in the continuous process environment [26].…”

Section: Resultsmentioning

confidence: 99%

Quantitative determinations using portable Raman spectroscopy

Navin

Tondepu

Toth

et al. 2017

Journal of Pharmaceutical and Biomedical Analysis

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A portable Raman spectrometer was used to develop chemometric models to determine percent (%) drug release and potency for 500mg ciprofloxacin HCl tablets. Parallel dissolution and chromatographic experiments were conducted alongside Raman experiments to assess and compare the performance and capabilities of portable Raman instruments in determining critical drug attributes. All batches tested passed the 30min dissolution specification and the Raman model for drug release was able to essentially reproduce the dissolution profiles obtained by ultraviolet spectroscopy at 276nm for all five batches of the 500mg ciprofloxacin tablets. The five batches of 500mg ciprofloxacin tablets also passed the potency (assay) specification and the % label claim for the entire set of tablets run were nearly identical, 99.4±5.1 for the portable Raman method and 99.2±1.2 for the chromatographic method. The results indicate that portable Raman spectrometers can be used to perform quantitative analysis of critical product attributes of finished drug products. The findings of this study indicate that portable Raman may have applications in the areas of process analytical technology and rapid pharmaceutical surveillance.

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“…Schaber et al predicted cost savings of up to 40% with CM compared to traditional batch manufacturing, once the capital investment paid off and sufficient experience in CM-process development was collected; other sources claim even higher savings [8,9]. Factors responsible for such saving potential in regards to resource consumption, foot-print reduction, efficiency, advanced process control and safety have been discussed in detail in literature before [10][11][12][13][14][15][16][17][18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

Predictive Model-Based Process Start-Up in Pharmaceutical Continuous Granulation and Drying

2020

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Continuous manufacturing (CM) is a promising strategy to achieve various benefits in the context of quality, flexibility, safety and cost in pharmaceutical production. One of the main technical challenges of CM is that the process needs to handle transient conditions such as the start-up phase before state of control operation is reached, which can potentially cause out-of-specification (OOS) material. In this context, the presented paper aims to demonstrate that suitable process control strategies during start-up of a continuous granulation and drying operation can limit or even avoid OOS material production and hence can ensure that the provided benefits of CM are not compromised by poor production yields. In detail, heat-up of the drying chamber prior the start of production can lead to thermal energy being stored inside of the stainless-steel housing, acting as an energy buffer that is known to cause over-dried granules in the first few minutes of the drying process. To compensate this issue, an automatic ramping procedure of dryer rotation speed (and hence drying time) was introduced into the plant’s process control system, which counteracts the excessive drying capacity during start-up. As a result, dry granules exiting the dryer complied with the targeted intermediate critical quality attribute loss-on-drying (LOD) from the very beginning of production.

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Regulatory and Quality Considerations for Continuous Manufacturing

Cited by 25 publications

References 0 publications

Enabling precision manufacturing of active pharmaceutical ingredients: workflow for seeded cooling continuous crystallisations

Enabling precision manufacturing of active pharmaceutical ingredients: workflow for seeded cooling continuous crystallisations

Quantitative determinations using portable Raman spectroscopy

Predictive Model-Based Process Start-Up in Pharmaceutical Continuous Granulation and Drying

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