Abstract
AT-cut quartz crystals vibrating in the thickness-shear mode (TSM), especially quartz crystal resonators (QCRs), are well known as very efficient mass sensitive systems because of their sensitivity, accuracy, and biofunctionalization capacity. They are highly reliable in the measurement of the mass of deposited samples, in both gas and liquid matrices. Moreover, they offer real-time monitoring, as well as relatively low production and operation costs. These features make mass sensitive systems applicable in a wide range of different applications, including studies on protein and peptide primary packaging, formulation, and drug product manufacturing process development. This review summarizes the information on some particular implementations of quartz crystal microbalance (QCM) instruments in protein and peptide drug product development as well as their future prospects.
Highlights
Biologics are currently one of the fastest growing sectors of the pharmaceutical industry [1].this group of modern and dynamically developing therapeutics constituted the majority of best-selling drugs in 2019 [2]
Development of drug products based on the abovementioned molecules is challenging and at the same time burdened by a high failure risk
More than 40 diseases in humans, including Alzheimer’s, Parkinson’s, Huntington’s, and prion diseases, non-neuropathic systemic amyloidosis, and various non-neuropathic localized diseases, such as cataract and type 2 diabetes mellitus [74], have been associated with aggregation of unfolded peptides and proteins into cytotoxic amyloid aggregates via the formation of intermolecular β-sheets [75]. They are likely to play a key role in numerous biological processes occurring in different organisms, e.g., human premelanosome amyloids can sequester highly reactive oxidative intermediates generated from melanin synthesis, and thereby protect melanocytes from oxidative damage [76]
Summary
Biologics are currently one of the fastest growing sectors of the pharmaceutical industry [1]. Development of drug products based on the abovementioned molecules is challenging and at the same time burdened by a high failure risk This results from the fact that both proteins and peptides, because of their structural complexity, are characterized by an enhanced susceptibility to various environmental factors [4]. Aggregation, as one of the physical degradation pathways in both protein and peptide drug products, has raised great concern among biopharmaceutical companies, academia, and regulatory agencies. This is due to the potential impact of some aggregates on Molecules 2020, 25, 3950; doi:10.3390/molecules25173950 www.mdpi.com/journal/molecules.
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