Editorial: Freeze-Drying and Process Analytical Technology for Pharmaceuticals

Fissore, Davide; McCoy, Timothy R.

doi:10.3389/fchem.2018.00622

Cited by 17 publications

(8 citation statements)

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“…[28,47] Moreover, most products are provided as a lyophilized premix rather than liquid and separated components. [48][49][50][51] Compared with liquid reagents, lyophilized premix products have two advantages. First, lyophilized reagents can be preserved at room temperature, which decreases the requirement for cold chain transportation and storage.…”

Section: Poctmentioning

confidence: 99%

Nucleic Acid Testing for Coronavirus Disease 2019: Demand, Research Progression, and Perspective

Zhang

Wang

et al. 2020

Critical Reviews in Analytical Chemistry

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The current coronavirus disease 2019 (COVID-19) outbreak, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a public health emergency of international concern. There has been a surge in demand for COVID-19 diagnostic reagents, as timely detection of virus carriers is one of the most important components of disease prevention and control. Nucleic acid testing (NAT), with high sensitivity and specificity, is considered the "gold standard" for the diagnosis of COVID-19. Therefore, more than 700 research units and companies have been devoted to developing NAT reagents. To date, nearly 600 research units and companies have claimed to have completed the development of NAT reagents. The use of these products has a positive effect on disease prevention and control; however, exaggerated claims and inadequate understanding of the products have led to improper access to reagents and equipment in clinics. This has resulted in chaos in the clinical diagnosis of COVID-19. Herein, we have overviewed the COVID-19 NAT products, including their principles, corresponding advantages and disadvantages, relevant circumstances for application, and respective roles in epidemic containment. Our comments may provide some references for assay developers and aid clinical staff in choosing the appropriate class of test from the different tests available.

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Section: Poctmentioning

confidence: 99%

Nucleic Acid Testing for Coronavirus Disease 2019: Demand, Research Progression, and Perspective

Zhang

Wang

et al. 2020

Critical Reviews in Analytical Chemistry

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“…However, traditional PCR reagents typically made for central laboratories are not applicable for microfluidic molecular diagnosis, unless a freeze-drying method is introduced. Firstly, traditional PCR reagents can't be stored at room temperature (RT) as the water molecules they contained drive many destabilization pathways [ 5 , 6 ]. Freeze-drying allows for the preservation of activity in qPCR reagents over the long-term storage at RT because this process removes most of the water molecules [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Transferable, easy-to-use and room-temperature-storable PCR mixes for microfluidic molecular diagnostics

Wang

et al. 2021

Talanta

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As the outbreak of coronavirus disease 2019 (COVID-19), on-site molecular diagnosis is becoming increasingly important. In this study, a freeze-drying method was introduced for PCR reagents to meet the requirements of microfluidic molecular diagnosis. Using this method, PCR components were pre-mixed and freeze-dried as a bead, which could be transferred into microfluidic chips easily. As this bead only required reconstitution in water, operational steps of PCR were simplified, pipetting errors and errors associated with improper handling of wet reagents could also be reduced. In addition, 19 PCR mixes for different targets (including both RNA and DNA) detection were stable when stored at room temperature (18–25 °C) for 1–2 years and may be stored longer as activity monitoring remains ongoing. To shorten the stability testing time, accelerated stability testing at higher temperatures was proposed. The evaluation periods of the freeze-dried PCR mixes were shortened to less than one month when stored at 56 °C and 80 °C. When attempts were further tried to predict the shelf lives for freeze-dried PCR mixes, our findings challenged the classic view of the Q 10 method as a prediction model for freeze-dried PCR mixes and confirmed for the first time that this prediction was influenced by different factors at varying degrees. These studies and findings are important for the development of molecular diagnosis at both central laboratories and resource-limited areas.

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“…Since, freeze-dying is a low-temperature process it is a very popular processing technique for heat-labile biological drug substances. Therefore, many of the approved biopharmaceuticals by the FDA and EMA are stabilized by lyophilisation [1]. However, freeze-drying is a long and costly process that require a lot of aseptic floor space [2].…”

Section: Introductionmentioning

confidence: 99%

Model-Based Optimisation and Control Strategy for the Primary Drying Phase of a Lyophilisation Process

et al. 2020

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The standard operation of a batch freeze-dryer is protocol driven. All freeze-drying phases (i.e., freezing, primary and secondary drying) are programmed sequentially at fixed time points and within each phase critical process parameters (CPPs) are typically kept constant or linearly interpolated between two setpoints. This way of operating batch freeze-dryers is shown to be time consuming and inefficient. A model-based optimisation and real-time control strategy that includes model output uncertainty could help in accelerating the primary drying phase while controlling the risk of failure of the critical quality attributes (CQAs). In each iteration of the real-time control strategy, a design space is computed to select an optimal set of CPPs. The aim of the control strategy is to avoid product structure loss, which occurs when the sublimation interface temperature ( T i ) exceeds the the collapse temperature ( T c ) common during unexpected disturbances, while preventing the choked flow conditions leading to a loss of pressure control. The proposed methodology was experimentally verified when the chamber pressure and shelf fluid system were intentionally subjected to moderate process disturbances. Moreover, the end of the primary drying phase was predicted using both uncertainty analysis and a comparative pressure measurement technique. Both the prediction of T i and end of primary drying were in agreement with the experimental data. Hence, it was confirmed that the proposed real-time control strategy is capable of mitigating the effect of moderate disturbances during batch freeze-drying.

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Editorial: Freeze-Drying and Process Analytical Technology for Pharmaceuticals

Cited by 17 publications

References 0 publications

Nucleic Acid Testing for Coronavirus Disease 2019: Demand, Research Progression, and Perspective

Nucleic Acid Testing for Coronavirus Disease 2019: Demand, Research Progression, and Perspective

Transferable, easy-to-use and room-temperature-storable PCR mixes for microfluidic molecular diagnostics

Model-Based Optimisation and Control Strategy for the Primary Drying Phase of a Lyophilisation Process

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